Trial Outcomes & Findings for Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent (NCT NCT04629521)

Results Overview

An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes sight-threatening adverse events as specified in the protocol. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

Month 96 (Year 8) to Month 120 (Year 10) postoperative

Results posted on

2024-04-26

Participant Flow

Participants were enrolled from 12 investigative sites located in the United States.

This reporting group includes all enrolled participants.

Participant milestones

Participant milestones
Measure	Cataract Surgery + CyPass CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Overall Study STARTED	54
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Cataract Surgery + CyPass CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Overall Study Death	1
Overall Study Lost to Follow-up	3
Overall Study Subject withdrew consent	3
Overall Study Enrolled in error	1

Baseline Characteristics

Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cataract Surgery + CyPass n=54 Participants CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Age, Continuous	78.3 years STANDARD_DEVIATION 6.87 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	50 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants
Race/Ethnicity, Customized White	48 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized \Native Hawaiian or Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Region of Enrollment United States	54 Participants n=5 Participants
Endothelial Cell Density (ECD)	2403.93 cells per square millimeter STANDARD_DEVIATION 362.028 • n=5 Participants

PRIMARY outcome

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes sight-threatening adverse events as specified in the protocol. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes With Sight-threatening Adverse Events (AEs) Persistent BCDVA loss of 3 lines or more compared to best BCDVA collected at any time during study	18.5 percentage of eyes Interval 9.3 to 31.4	—	—	—	—	—
Percentage of Eyes With Sight-threatening Adverse Events (AEs) Endophthalmitis	0.0 percentage of eyes Interval 0.0 to 6.6	—	—	—	—	—
Percentage of Eyes With Sight-threatening Adverse Events (AEs) Corneal decompensation	0.0 percentage of eyes Interval 0.0 to 6.6	—	—	—	—	—
Percentage of Eyes With Sight-threatening Adverse Events (AEs) Retinal detachment	0.0 percentage of eyes Interval 0.0 to 6.6	—	—	—	—	—
Percentage of Eyes With Sight-threatening Adverse Events (AEs) Severe choroidal hemorrhage or detachment	0.0 percentage of eyes Interval 0.0 to 6.6	—	—	—	—	—
Percentage of Eyes With Sight-threatening Adverse Events (AEs) Aqueous misdirection	0.0 percentage of eyes Interval 0.0 to 6.6	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes ocular events other than sight-threatening adverse events. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes With Ocular Adverse Events Visual Field Defect	37.0 percentage of eyes Interval 24.3 to 51.3	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Corneal Endothelial Cell Loss	11.1 percentage of eyes Interval 4.2 to 22.6	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Trabeculectomy	3.7 percentage of eyes Interval 0.5 to 12.7	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Cystoid Macular Oedema	1.9 percentage of eyes Interval 0.0 to 9.9	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Visual Acuity Reduced	38.9 percentage of eyes Interval 25.9 to 53.1	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Post Procedural Complication	9.3 percentage of eyes Interval 3.1 to 20.3	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Device Placement Issue	5.6 percentage of eyes Interval 1.2 to 15.4	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Hypotony Of Eye	3.7 percentage of eyes Interval 0.5 to 12.7	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Intraocular Pressure Increased	3.7 percentage of eyes Interval 0.5 to 12.7	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Optic Nerve Cup/Disc Ratio	3.7 percentage of eyes Interval 0.5 to 12.7	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Dermatitis	1.9 percentage of eyes Interval 0.0 to 9.9	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Device Dislocation	1.9 percentage of eyes Interval 0.0 to 9.9	—	—	—	—	—
Percentage of Eyes With Ocular Adverse Events Trabeculoplasty	1.9 percentage of eyes Interval 0.0 to 9.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation Month 96 (Year 8)	1802.49 cells per millimeter squared Standard Deviation 520.329	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation Month 108 (Year 9)	1668.80 cells per millimeter squared Standard Deviation 707.729	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation Month 120 (Year 10)	1574.73 cells per millimeter squared Standard Deviation 714.996	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval Month 96 (Year 8)	1802.49 cells per millimeter squared Interval 1321.26 to 2283.71	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval Month 108 (Year 9)	1668.80 cells per millimeter squared Interval 1448.26 to 1889.35	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval Month 120 (Year 10)	1574.73 cells per millimeter squared Interval 1339.73 to 1809.74	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 0 percentile	909.7 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 5th percentile	909.7 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 25th percentile	1412.5 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 50th percentile	1959.2 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 75th percentile	2185.3 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 95th percentile	2460.0 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 100th percentile	2460.0 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 108 (Year 9) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=42 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 0 percentile	458.8 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 95th percentile	2546.0 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 5th percentile	561.0 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 25th percentile	805.7 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 50th percentile	1867.0 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 75th percentile	2222.8 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 100th percentile	2660.8 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=38 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 0 percentile	413.5 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 5th percentile	415.7 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 25th percentile	796.6 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 50th percentile	1640.0 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 75th percentile	2165.3 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 95th percentile	2597.5 cells per millimeter squared	—	—	—	—	—
Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 100th percentile	2800.8 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation Month 96 (Year 8)	1844.51 cells per millimeter squared Standard Deviation 684.727	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation Month 108 (Year 9)	1739.44 cells per millimeter squared Standard Deviation 779.814	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation Month 120 (Year 10)	1688.74 cells per millimeter squared Standard Deviation 803.605	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval Month 96 (Year 8)	1844.51 cells per millimeter squared Interval 1211.25 to 2477.78	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval Month 108 (Year 9)	1739.44 cells per millimeter squared Interval 1496.44 to 1982.45	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval Month 120 (Year 10)	1688.74 cells per millimeter squared Interval 1388.87 to 1988.61	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) postoperative

Population: All enrolled with data at visit

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 0 percentile	489.7 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 5th percentile	489.7 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 25th percentile	1390.6 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 50th percentile	2132.7 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 75th percentile	2227.0 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 95th percentile	2465.2 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) 100th percentile	2465.2 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 108 (Year 9) postoperative

Population: All enrolled with data at visit

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=42 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 100th percentile	2814.0 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 0 percentile	449.5 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 5th percentile	510.0 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 25th percentile	1024.5 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 50th percentile	2020.5 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 75th percentile	2341.0 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) 95th percentile	2772.0 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=30 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 0 percentile	353.3 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 5th percentile	477.0 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 25th percentile	856.5 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 50th percentile	1865.4 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 75th percentile	2345.5 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 95th percentile	2637.3 cells per millimeter squared	—	—	—	—	—
Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) 100th percentile	3183.7 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation Month 96 (Year 8)	28.19 unitless Standard Deviation 3.189	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation Month 108 (Year 9)	29.25 unitless Standard Deviation 5.507	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation Month 120 (Year 10)	30.57 unitless Standard Deviation 5.001	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) postoperative

Population: All enrolled with data at visit

The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) 0 percentile	23.8 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) 95th percentile	32.3 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) 5th percentile	23.8 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) 25th percentile	24.8 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) 50th percentile	28.2 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) 75th percentile	31.0 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8) 100th percentile	32.3 unitless	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 108 (Year 9) postoperative

Population: All enrolled with data at visit

The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=42 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) 0 percentile	8.0 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) 5th percentile	20.5 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) 25th percentile	27.0 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) 50th percentile	29.4 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) 75th percentile	32.2 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) 95th percentile	36.3 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9) 100th percentile	39.5 unitless	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

The CECCV is a measurement used in assessing the variability and quantifying the degree of variation in endothelial cell size within the central cornea. The CECCV measurements were obtained using specular microscopy from endothelial cells within the central region of the cornea. A higher CECCV suggests greater variability in endothelial cell size within the central cornea and may suggest underlying endothelial cell pathology, such as stress, aging, or certain corneal diseases (e.g. Fuch's endothelial dystrophy). A lower CECCV indicates more uniform cell size distribution, which is typically associated with a healthier endothelial function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=38 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) 50th percentile	30.8 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) 75th percentile	33.8 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) 0 percentile	16.5 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) 5th percentile	21.5 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) 25th percentile	27.8 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) 95th percentile	38.8 unitless	—	—	—	—	—
Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10) 100th percentile	40.5 unitless	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation Month 96 (Year 8)	64.33 percentage of hexagonality Standard Deviation 5.223	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation Month 108 (Year 9)	60.96 percentage of hexagonality Standard Deviation 8.235	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation Month 120 (Year 10)	62.09 percentage of hexagonality Standard Deviation 8.589	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) postoperative

Population: All enrolled with data at visit

The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) 0 percentile	57.7 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) 5th percentile	57.7 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) 25th percentile	59.3 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) 50th percentile	66.0 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) 75th percentile	68.3 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) 95th percentile	71.5 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8) 100th percentile	71.5 percentage of hexagonality	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 108 (Year 9) postoperative

Population: All enrolled with data at visit

The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=42 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) 0 percentile	41.0 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) 5th percentile	44.3 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) 25th percentile	57.8 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) 50th percentile	60.8 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) 75th percentile	65.7 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) 95th percentile	72.5 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9) 100th percentile	80.7 percentage of hexagonality	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

The CEH is a measurement used in assessing the regularity of endothelial cell shape within the central cornea. It provides insights into the structural integrity of the corneal endothelium, aiding in the evaluation of corneal health and diagnosis of endothelial cell-related pathologies. The CEH measurement was obtained using specular microscopy, a non-invasive imaging technique that assesses the regularity of endothelial cell shape within the central cornea. A normal cornea is of hexagonal shape. A higher CEH indicates a greater proportion of endothelial cells with a hexagonal shape, which is associated with a more regular and healthier endothelial cell morphology. A lower CEH suggests decreased hexagonality and may indicate abnormalities in endothelial cell structure or function. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=38 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) 0 percentile	43.3 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) 5th percentile	44.0 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) 25th percentile	57.8 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) 50th percentile	63.4 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) 75th percentile	68.2 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) 95th percentile	75.8 percentage of hexagonality	—	—	—	—	—
Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10) 100th percentile	78.3 percentage of hexagonality	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 96 (Year 8)	-612.31 cells per millimeter squared Standard Deviation 704.719	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 108 (Year 9)	-762.63 cells per millimeter squared Standard Deviation 706.732	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 120 (Year 10)	-819.62 cells per millimeter squared Standard Deviation 696.501	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 96 (Year 8)	-612.31 cells per millimeter squared Interval -1264.07 to 39.44	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 108 (Year 9)	-762.63 cells per millimeter squared Interval -982.86 to -542.39	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 120 (Year 10)	-819.62 cells per millimeter squared Interval -1048.56 to -590.69	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 5th percentile	-1802.6 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 25th percentile	-1246.7 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 50th percentile	-444.5 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 75th percentile	60.2 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 95th percentile	161.8 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 100th percentile	161.8 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 0 percentile	-1802.6 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=42 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 0 percentile	-2028.0 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 5th percentile	-1893.8 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 25th percentile	-1450.1 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 50th percentile	-590.3 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 75th percentile	-198.3 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 95th percentile	308.0 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 100th percentile	807.6 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative change value indicates a lessening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=38 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 0 percentile	-1937.5 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 5th percentile	-1873.7 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 25th percentile	-1416.4 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 50th percentile	-907.6 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 75th percentile	-232.0 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 95th percentile	253.8 cells per millimeter squared	—	—	—	—	—
Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 100th percentile	752.1 cells per millimeter squared	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 96 (Year 8)	-22.77 percent change Standard Deviation 26.468	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 108 (Year 9)	-30.60 percent change Standard Deviation 31.070	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 120 (Year 10)	-33.57 percent change Standard Deviation 31.673	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 96 (Year 8)	-22.77 percent change Interval -47.25 to 1.71	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 108 (Year 9)	-30.60 percent change Interval -40.28 to -20.92	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 120 (Year 10)	-33.57 percent change Interval -43.98 to -23.16	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 0 percentile	-66.5 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 5th percentile	-66.5 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 25th percentile	-46.9 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 50th percentile	-16.9 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 75th percentile	3.8 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 95th percentile	7.0 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8) 100th percentile	7.0 percent change	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=42 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 0 percentile	-79.9 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 5th percentile	-74.8 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 25th percentile	-65.5 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 50th percentile	-24.9 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 75th percentile	-8.1 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 95th percentile	18.0 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9) 100th percentile	50.1 percent change	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A negative percent change value indicates a worsening of corneal health and function. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=38 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 0 percentile	-81.9 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 5th percentile	-80.1 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 25th percentile	-61.9 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 50th percentile	-35.8 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 75th percentile	-8.6 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 95th percentile	16.7 percent change	—	—	—	—	—
Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10) 100th percentile	46.7 percent change	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 3	0.0 percentage of eyes Interval 0.0 to 6.8	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 6	0.0 percentage of eyes Interval 0.0 to 6.7	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 24 (Year 2)	1.9 percentage of eyes Interval 0.0 to 10.1	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 108 (Year 9)	26.2 percentage of eyes Interval 13.9 to 42.0	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 120 (Year 10)	31.6 percentage of eyes Interval 17.5 to 48.7	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 12 (Year 1)	0.0 percentage of eyes Interval 0.0 to 6.6	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 36 (Year 3)	0.0 percentage of eyes Interval 0.0 to 70.8	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 48 (Year 4)	9.7 percentage of eyes Interval 2.0 to 25.8	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 60 (Year 5)	6.7 percentage of eyes Interval 1.4 to 18.3	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 96 (Year 8)	14.3 percentage of eyes Interval 0.4 to 57.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 12 (Year 1)	0.0 percentage of eyes Interval 0.0 to 6.6	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 24 (Year 2)	0.0 percentage of eyes Interval 0.0 to 6.7	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 36 (Year 3)	0.0 percentage of eyes Interval 0.0 to 70.8	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 48 (Year 4)	0.0 percentage of eyes Interval 0.0 to 11.2	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 96 (Year 8)	0.0 percentage of eyes Interval 0.0 to 41.0	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 108 (Year 9)	2.4 percentage of eyes Interval 0.1 to 12.6	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 120 (Year 10)	7.9 percentage of eyes Interval 1.7 to 21.4	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 3	0.0 percentage of eyes Interval 0.0 to 6.8	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 6	0.0 percentage of eyes Interval 0.0 to 6.7	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 60 (Year 5)	0.0 percentage of eyes Interval 0.0 to 7.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS, COMPASS XT, and COMPASS XXT studies. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 3	9.6 percentage of eyes Interval 3.2 to 21.0	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 6	9.4 percentage of eyes Interval 3.1 to 20.7	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 12 (Year 1)	13.0 percentage of eyes Interval 5.4 to 24.9	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 24 (Year 2)	9.4 percentage of eyes Interval 3.1 to 20.7	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 36 (Year 3)	0.0 percentage of eyes Interval 0.0 to 70.8	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 48 (Year 4)	19.4 percentage of eyes Interval 7.5 to 37.5	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 60 (Year 5)	26.7 percentage of eyes Interval 14.6 to 41.9	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 108 (Year 9)	40.5 percentage of eyes Interval 25.6 to 56.7	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 120 (Year 10)	52.6 percentage of eyes Interval 35.8 to 69.0	—	—	—	—	—
Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline >30% Loss from Baseline at Month 96 (Year 8)	28.6 percentage of eyes Interval 3.7 to 71.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 96 (Year 8)	14.3 percentage of eyes Interval 0.4 to 57.9	—	—	—	—	—
Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 108 (Year 9)	23.8 percentage of eyes Interval 12.1 to 39.5	—	—	—	—	—
Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared Month 120 (Year 20)	30.0 percentage of eyes Interval 14.7 to 49.4	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=53 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 120 (Year 20)	6.7 percentage of eyes Interval 0.8 to 22.1	—	—	—	—	—
Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 96 (Year 8)	14.3 percentage of eyes Interval 0.4 to 57.9	—	—	—	—	—
Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared Month 108 (Year 9)	4.8 percentage of eyes Interval 0.6 to 16.2	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive annualized rate of change indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative annualized rate of change signifies a decrease in central ECD, which may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 9 to Year 10	-44.00 [cells per millimeter squared] per year Standard Deviation 221.290	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Baseline to Year 1	-267.77 [cells per millimeter squared] per year Standard Deviation 405.731	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 1 to Year 2	-23.80 [cells per millimeter squared] per year Standard Deviation 149.533	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 2 to Year 3	-118.83 [cells per millimeter squared] per year Standard Deviation 90.832	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 3 to Year 4	-63.57 [cells per millimeter squared] per year Standard Deviation 57.630	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 4 to Year 5	-95.54 [cells per millimeter squared] per year Standard Deviation 191.951	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 8 to Year 9	-138.10 [cells per millimeter squared] per year Standard Deviation 169.597	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive annualized rate of change indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative annualized rate of change signifies a decrease in central ECD, which may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Baseline to Year 1	-267.77 [cells per millimeter squared] per year Interval -378.51 to -157.02	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 4 to Year 5	-95.54 [cells per millimeter squared] per year Interval -167.22 to -23.87	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 8 to Year 9	-138.10 [cells per millimeter squared] per year Interval -316.08 to 39.88	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 9 to Year 10	-44.00 [cells per millimeter squared] per year Interval -129.81 to 41.81	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 1 to Year 2	-23.80 [cells per millimeter squared] per year Interval -65.01 to 17.42	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 2 to Year 3	-118.83 [cells per millimeter squared] per year Interval -344.47 to 106.81	—	—	—	—	—
Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 3 to Year 4	-63.57 [cells per millimeter squared] per year Interval -206.73 to 79.59	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive percent change per year indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative percent change per year may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Central ECD was measured in cells per millimeter squared. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 3 to Year 4	-2.72 percent change per year Standard Deviation 2.446	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 9 to Year 10	-2.82 percent change per year Standard Deviation 14.357	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Baseline to Year 1	-10.15 percent change per year Standard Deviation 16.780	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 1 to Year 2	-1.24 percent change per year Standard Deviation 9.180	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 2 to Year 3	-4.86 percent change per year Standard Deviation 3.780	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 4 to Year 5	-5.14 percent change per year Standard Deviation 9.946	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation Year 8 to Year 9	-8.52 percent change per year Standard Deviation 10.508	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

The annualized rate of change in central ECD is used to quantify the rate at which the central ECD changes over time. The annualized rate of change in central ECD is determined by dividing the change in ECD by the duration of observation (in years). A positive percent change per year indicates an increase in central ECD over time, suggesting a favorable outcome or the effectiveness of interventions aimed at preserving endothelial cell density. A negative percent change per year may indicate endothelial cell loss due to factors such as aging, disease progression, or the surgical interventions. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Central ECD was measured in cells per millimeter squared. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 2 to Year 3	-4.86 percent change per year Interval -14.25 to 4.53	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 3 to Year 4	-2.72 percent change per year Interval -8.79 to 3.36	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 4 to Year 5	-5.14 percent change per year Interval -8.85 to -1.43	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 8 to Year 9	-8.52 percent change per year Interval -19.54 to 2.51	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 9 to Year 10	-2.82 percent change per year Interval -8.39 to 2.74	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Baseline to Year 1	-10.15 percent change per year Interval -14.73 to -5.57	—	—	—	—	—
Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval Year 1 to Year 2	-1.24 percent change per year Interval -3.77 to 1.29	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

Corneal sequelae are occurrences of complications related to ECL in the cornea and may include corneal edema, decreased visual acuity, corneal decompensation, bullous keratopathy, etc. Corneal sequelae were quantified by counting the instances where patients experienced complications attributable to endothelial cell loss. A higher number of corneal sequelae events may indicate rapid disease progression or inadequate management of conditions leading to endothelial cell loss. A lower number of corneal sequelae events may indicate a favorable response to treatment and successful disease treatment or treatment stabilization. This analysis was performed using data from the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Number of Corneal Sequelae Events Associated With Endothelial Cell Loss (ECL)	0 corneal sequelae	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10)

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 6	1769.03 cells per millimeter squared Standard Deviation 624.608	2394.50 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	2206.81 cells per millimeter squared Standard Deviation 383.001	2226.18 cells per millimeter squared Standard Deviation 324.459	2160.54 cells per millimeter squared Standard Deviation 309.941	2012.45 cells per millimeter squared Standard Deviation 66.256
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 3	1913.03 cells per millimeter squared Standard Deviation 583.158	—	2159.24 cells per millimeter squared Standard Deviation 467.711	2154.11 cells per millimeter squared Standard Deviation 309.015	2368.27 cells per millimeter squared Standard Deviation 306.424	2035.25 cells per millimeter squared Standard Deviation 7.707
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 12 (Year 1)	2000.93 cells per millimeter squared Standard Deviation 461.735	1756.30 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	2272.34 cells per millimeter squared Standard Deviation 345.825	2261.04 cells per millimeter squared Standard Deviation 394.756	2139.71 cells per millimeter squared Standard Deviation 307.753	1492.95 cells per millimeter squared Standard Deviation 293.379
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 36 (Year 3)	—	—	2324.50 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	2338.00 cells per millimeter squared Standard Deviation 199.121	—	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 120 (Year 10)	1897.05 cells per millimeter squared Standard Deviation 730.546	1663.71 cells per millimeter squared Standard Deviation 593.233	1941.97 cells per millimeter squared Standard Deviation 661.397	1486.70 cells per millimeter squared Standard Deviation 721.315	924.90 cells per millimeter squared Standard Deviation 421.601	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 24 (Year 2)	1938.18 cells per millimeter squared Standard Deviation 529.916	2449.60 cells per millimeter squared Standard Deviation 70.295	2189.33 cells per millimeter squared Standard Deviation 388.648	2144.41 cells per millimeter squared Standard Deviation 400.509	2186.23 cells per millimeter squared Standard Deviation 362.508	1309.70 cells per millimeter squared Standard Deviation 870.024
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 48 (Year 4)	2062.20 cells per millimeter squared Standard Deviation 364.440	2555.70 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	2307.67 cells per millimeter squared Standard Deviation 280.270	2117.21 cells per millimeter squared Standard Deviation 301.552	1616.86 cells per millimeter squared Standard Deviation 601.855	742.00 cells per millimeter squared Standard Deviation 36.062
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 60 (Year 5)	2292.05 cells per millimeter squared Standard Deviation 381.087	2342.00 cells per millimeter squared Standard Deviation 27.577	2159.78 cells per millimeter squared Standard Deviation 375.998	2016.68 cells per millimeter squared Standard Deviation 495.751	1645.16 cells per millimeter squared Standard Deviation 433.827	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 96 (Year 8)	1660.70 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	1412.50 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	2185.30 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	2209.60 cells per millimeter squared Standard Deviation 354.119	1469.85 cells per millimeter squared Standard Deviation 792.172	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 108 (Year 9)	1894.88 cells per millimeter squared Standard Deviation 639.384	1735.63 cells per millimeter squared Standard Deviation 232.046	2049.77 cells per millimeter squared Standard Deviation 585.452	1720.05 cells per millimeter squared Standard Deviation 740.783	925.40 cells per millimeter squared Standard Deviation 401.250	—

PRIMARY outcome

Timeframe: Month 3 postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 0 percentile	1364.2 cells per millimeter squared	1230.3 cells per millimeter squared	1592.5 cells per millimeter squared	2179.0 cells per millimeter squared	2029.8 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 50th percentile	1920.0 cells per millimeter squared	2361.3 cells per millimeter squared	2171.5 cells per millimeter squared	2204.0 cells per millimeter squared	2035.3 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 75th percentile	2416.6 cells per millimeter squared	2506.3 cells per millimeter squared	2351.5 cells per millimeter squared	2721.8 cells per millimeter squared	2040.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 100th percentile	2447.9 cells per millimeter squared	2549.8 cells per millimeter squared	2600.8 cells per millimeter squared	2721.8 cells per millimeter squared	2040.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 5th percentile	1364.2 cells per millimeter squared	1230.3 cells per millimeter squared	1592.5 cells per millimeter squared	2179.0 cells per millimeter squared	2029.8 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 25th percentile	1409.5 cells per millimeter squared	1879.4 cells per millimeter squared	2025.1 cells per millimeter squared	2179.0 cells per millimeter squared	2029.8 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3 95th percentile	2447.9 cells per millimeter squared	2549.8 cells per millimeter squared	2600.8 cells per millimeter squared	2721.8 cells per millimeter squared	2040.7 cells per millimeter squared	—

PRIMARY outcome

Timeframe: Month 6 postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=34 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=34 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=34 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=34 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=34 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings n=34 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 0 percentile	1361.1 cells per millimeter squared	2394.5 cells per millimeter squared	1418.0 cells per millimeter squared	1672.0 cells per millimeter squared	1693.7 cells per millimeter squared	1965.6 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 5th percentile	1361.1 cells per millimeter squared	2394.5 cells per millimeter squared	1418.0 cells per millimeter squared	1672.0 cells per millimeter squared	1693.7 cells per millimeter squared	1965.6 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 25th percentile	1361.1 cells per millimeter squared	2394.5 cells per millimeter squared	2043.0 cells per millimeter squared	2109.2 cells per millimeter squared	1899.7 cells per millimeter squared	1965.6 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 75th percentile	2488.1 cells per millimeter squared	2394.5 cells per millimeter squared	2463.9 cells per millimeter squared	2558.3 cells per millimeter squared	2304.3 cells per millimeter squared	2059.3 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 50th percentile	1457.9 cells per millimeter squared	2394.5 cells per millimeter squared	2337.7 cells per millimeter squared	2257.5 cells per millimeter squared	2248.6 cells per millimeter squared	2012.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 95th percentile	2488.1 cells per millimeter squared	2394.5 cells per millimeter squared	2547.5 cells per millimeter squared	2662.3 cells per millimeter squared	2650.8 cells per millimeter squared	2059.3 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6 100th percentile	2488.1 cells per millimeter squared	2394.5 cells per millimeter squared	2547.5 cells per millimeter squared	2662.3 cells per millimeter squared	2650.8 cells per millimeter squared	2059.3 cells per millimeter squared

PRIMARY outcome

Timeframe: Month 12 (Year 1) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) 25th percentile	1666.8 cells per millimeter squared	1756.3 cells per millimeter squared	2146.8 cells per millimeter squared	2125.7 cells per millimeter squared	1907.0 cells per millimeter squared	1285.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) 0 percentile	1357.7 cells per millimeter squared	1756.3 cells per millimeter squared	1388.7 cells per millimeter squared	1340.5 cells per millimeter squared	1659.6 cells per millimeter squared	1285.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) 5th percentile	1357.7 cells per millimeter squared	1756.3 cells per millimeter squared	1388.7 cells per millimeter squared	1531.0 cells per millimeter squared	1659.6 cells per millimeter squared	1285.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) 50th percentile	2139.9 cells per millimeter squared	1756.3 cells per millimeter squared	2414.8 cells per millimeter squared	2359.3 cells per millimeter squared	2234.2 cells per millimeter squared	1493.0 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) 75th percentile	2335.1 cells per millimeter squared	1756.3 cells per millimeter squared	2480.7 cells per millimeter squared	2563.3 cells per millimeter squared	2293.8 cells per millimeter squared	1700.4 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) 95th percentile	2366.3 cells per millimeter squared	1756.3 cells per millimeter squared	2579.2 cells per millimeter squared	2666.0 cells per millimeter squared	2588.2 cells per millimeter squared	1700.4 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1) 100th percentile	2366.3 cells per millimeter squared	1756.3 cells per millimeter squared	2579.2 cells per millimeter squared	2852.3 cells per millimeter squared	2588.2 cells per millimeter squared	1700.4 cells per millimeter squared

PRIMARY outcome

Timeframe: Month 24 (Year 2) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=50 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=50 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=50 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=50 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=50 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings n=50 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) 5th percentile	1350.2 cells per millimeter squared	2370.2 cells per millimeter squared	1301.3 cells per millimeter squared	1526.7 cells per millimeter squared	1390.0 cells per millimeter squared	694.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) 50th percentile	2047.7 cells per millimeter squared	2474.7 cells per millimeter squared	2345.9 cells per millimeter squared	2152.7 cells per millimeter squared	2226.4 cells per millimeter squared	1309.7 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) 75th percentile	2318.7 cells per millimeter squared	2503.9 cells per millimeter squared	2443.3 cells per millimeter squared	2503.2 cells per millimeter squared	2373.1 cells per millimeter squared	1924.9 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) 95th percentile	2542.1 cells per millimeter squared	2503.9 cells per millimeter squared	2624.5 cells per millimeter squared	2757.6 cells per millimeter squared	2732.7 cells per millimeter squared	1924.9 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) 100th percentile	2542.1 cells per millimeter squared	2503.9 cells per millimeter squared	2624.5 cells per millimeter squared	2757.6 cells per millimeter squared	2732.7 cells per millimeter squared	1924.9 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) 0 percentile	1350.2 cells per millimeter squared	2370.2 cells per millimeter squared	1301.3 cells per millimeter squared	1526.7 cells per millimeter squared	1390.0 cells per millimeter squared	694.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2) 25th percentile	1432.2 cells per millimeter squared	2370.2 cells per millimeter squared	1961.0 cells per millimeter squared	1721.2 cells per millimeter squared	2071.9 cells per millimeter squared	694.5 cells per millimeter squared

PRIMARY outcome

Timeframe: Month 36 (Year 3) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=3 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=3 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) 0 percentile	2324.5 cells per millimeter squared	2197.2 cells per millimeter squared	—	—	—	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) 5th percentile	2324.5 cells per millimeter squared	2197.2 cells per millimeter squared	—	—	—	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) 75th percentile	2324.5 cells per millimeter squared	2478.8 cells per millimeter squared	—	—	—	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) 25th percentile	2324.5 cells per millimeter squared	2197.2 cells per millimeter squared	—	—	—	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) 50th percentile	2324.5 cells per millimeter squared	2338.0 cells per millimeter squared	—	—	—	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) 95th percentile	2324.5 cells per millimeter squared	2478.8 cells per millimeter squared	—	—	—	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3) 100th percentile	2324.5 cells per millimeter squared	2478.8 cells per millimeter squared	—	—	—	—

PRIMARY outcome

Timeframe: Month 48 (Year 4) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings n=31 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) 0 percentile	1684.7 cells per millimeter squared	2555.7 cells per millimeter squared	1678.7 cells per millimeter squared	1524.0 cells per millimeter squared	752.5 cells per millimeter squared	716.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) 5th percentile	1684.7 cells per millimeter squared	2555.7 cells per millimeter squared	1678.7 cells per millimeter squared	1524.0 cells per millimeter squared	752.5 cells per millimeter squared	716.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) 25th percentile	1684.7 cells per millimeter squared	2555.7 cells per millimeter squared	2304.0 cells per millimeter squared	2034.8 cells per millimeter squared	1468.8 cells per millimeter squared	716.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) 50th percentile	2089.9 cells per millimeter squared	2555.7 cells per millimeter squared	2334.0 cells per millimeter squared	2107.5 cells per millimeter squared	1550.2 cells per millimeter squared	742.0 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) 75th percentile	2412.0 cells per millimeter squared	2555.7 cells per millimeter squared	2475.2 cells per millimeter squared	2375.3 cells per millimeter squared	1940.5 cells per millimeter squared	767.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) 95th percentile	2412.0 cells per millimeter squared	2555.7 cells per millimeter squared	2683.7 cells per millimeter squared	2537.5 cells per millimeter squared	2372.3 cells per millimeter squared	767.5 cells per millimeter squared
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4) 100th percentile	2412.0 cells per millimeter squared	2555.7 cells per millimeter squared	2683.7 cells per millimeter squared	2537.5 cells per millimeter squared	2372.3 cells per millimeter squared	767.5 cells per millimeter squared

PRIMARY outcome

Timeframe: Month 60 (Year 5) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=43 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=43 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=43 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=43 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=43 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) 50th percentile	2342.7 cells per millimeter squared	2342.0 cells per millimeter squared	2277.9 cells per millimeter squared	2035.8 cells per millimeter squared	1743.6 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) 0 percentile	1683.7 cells per millimeter squared	2322.5 cells per millimeter squared	1345.3 cells per millimeter squared	1109.0 cells per millimeter squared	741.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) 5th percentile	1683.7 cells per millimeter squared	2322.5 cells per millimeter squared	1345.3 cells per millimeter squared	1109.0 cells per millimeter squared	741.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) 25th percentile	2050.2 cells per millimeter squared	2322.5 cells per millimeter squared	2080.0 cells per millimeter squared	1734.2 cells per millimeter squared	1372.0 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) 75th percentile	2589.3 cells per millimeter squared	2361.5 cells per millimeter squared	2411.7 cells per millimeter squared	2417.7 cells per millimeter squared	1912.5 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) 95th percentile	2743.8 cells per millimeter squared	2361.5 cells per millimeter squared	2555.8 cells per millimeter squared	2958.7 cells per millimeter squared	2242.5 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5) 100th percentile	2743.8 cells per millimeter squared	2361.5 cells per millimeter squared	2555.8 cells per millimeter squared	2958.7 cells per millimeter squared	2242.5 cells per millimeter squared	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 25th percentile	1660.7 cells per millimeter squared	1412.5 cells per millimeter squared	2185.3 cells per millimeter squared	1959.2 cells per millimeter squared	909.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 0 percentile	1660.7 cells per millimeter squared	1412.5 cells per millimeter squared	2185.3 cells per millimeter squared	1959.2 cells per millimeter squared	909.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 5th percentile	1660.7 cells per millimeter squared	1412.5 cells per millimeter squared	2185.3 cells per millimeter squared	1959.2 cells per millimeter squared	909.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 50th percentile	1660.7 cells per millimeter squared	1412.5 cells per millimeter squared	2185.3 cells per millimeter squared	2209.6 cells per millimeter squared	1469.9 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 75th percentile	1660.7 cells per millimeter squared	1412.5 cells per millimeter squared	2185.3 cells per millimeter squared	2460.0 cells per millimeter squared	2030.0 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 95th percentile	1660.7 cells per millimeter squared	1412.5 cells per millimeter squared	2185.3 cells per millimeter squared	2460.0 cells per millimeter squared	2030.0 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 100th percentile	1660.7 cells per millimeter squared	1412.5 cells per millimeter squared	2185.3 cells per millimeter squared	2460.0 cells per millimeter squared	2030.0 cells per millimeter squared	—

PRIMARY outcome

Timeframe: Month 108 (Year 9) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 0 percentile	547.5 cells per millimeter squared	1438.5 cells per millimeter squared	699.3 cells per millimeter squared	458.8 cells per millimeter squared	568.3 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 5th percentile	547.5 cells per millimeter squared	1438.5 cells per millimeter squared	699.3 cells per millimeter squared	458.8 cells per millimeter squared	568.3 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 25th percentile	1612.0 cells per millimeter squared	1583.6 cells per millimeter squared	2131.3 cells per millimeter squared	805.7 cells per millimeter squared	684.3 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 50th percentile	2180.7 cells per millimeter squared	1750.1 cells per millimeter squared	2217.2 cells per millimeter squared	2014.7 cells per millimeter squared	783.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 75th percentile	2222.8 cells per millimeter squared	1887.7 cells per millimeter squared	2362.5 cells per millimeter squared	2301.0 cells per millimeter squared	1057.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 95th percentile	2573.2 cells per millimeter squared	2003.8 cells per millimeter squared	2660.8 cells per millimeter squared	2546.0 cells per millimeter squared	1674.8 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 100th percentile	2573.2 cells per millimeter squared	2003.8 cells per millimeter squared	2660.8 cells per millimeter squared	2546.0 cells per millimeter squared	1674.8 cells per millimeter squared	—

PRIMARY outcome

Timeframe: Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed using data from the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=36 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=36 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=36 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=36 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=36 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 75th percentile	2177.4 cells per millimeter squared	2102.7 cells per millimeter squared	2359.1 cells per millimeter squared	1960.5 cells per millimeter squared	1094.2 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 95th percentile	2597.5 cells per millimeter squared	2363.3 cells per millimeter squared	2800.8 cells per millimeter squared	2479.7 cells per millimeter squared	1508.3 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 0 percentile	483.5 cells per millimeter squared	796.6 cells per millimeter squared	624.7 cells per millimeter squared	413.5 cells per millimeter squared	415.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 5th percentile	483.5 cells per millimeter squared	796.6 cells per millimeter squared	624.7 cells per millimeter squared	413.5 cells per millimeter squared	415.7 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 25th percentile	1881.9 cells per millimeter squared	951.7 cells per millimeter squared	1503.2 cells per millimeter squared	782.7 cells per millimeter squared	640.3 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 50th percentile	2121.0 cells per millimeter squared	1849.5 cells per millimeter squared	2165.3 cells per millimeter squared	1637.8 cells per millimeter squared	966.0 cells per millimeter squared	—
Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 100th percentile	2597.5 cells per millimeter squared	2363.3 cells per millimeter squared	2800.8 cells per millimeter squared	2479.7 cells per millimeter squared	1508.3 cells per millimeter squared	—

PRIMARY outcome

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=48 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 120 (Year 10)	2177.90 cells per millimeter squared Standard Deviation 988.439	1955.98 cells per millimeter squared Standard Deviation 348.144	1663.57 cells per millimeter squared Standard Deviation 730.987	1683.19 cells per millimeter squared Standard Deviation 909.922	976.46 cells per millimeter squared Standard Deviation 550.677	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 96 (Year 8)	2132.70 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	1390.60 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	2227.00 cells per millimeter squared Standard Deviation NA Standard deviation is undefined when there is no variability in the data	2103.20 cells per millimeter squared Standard Deviation 152.028	1477.45 cells per millimeter squared Standard Deviation 1396.889	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation Month 108 (Year 9)	2062.49 cells per millimeter squared Standard Deviation 728.658	1828.05 cells per millimeter squared Standard Deviation 399.061	2087.86 cells per millimeter squared Standard Deviation 599.144	1752.28 cells per millimeter squared Standard Deviation 835.401	915.63 cells per millimeter squared Standard Deviation 585.915	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) postoperative

Population: All enrolled with data at visit

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=7 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 5th percentile	2132.7 cells per millimeter squared	1390.6 cells per millimeter squared	2227.0 cells per millimeter squared	1995.7 cells per millimeter squared	489.7 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 0 percentile	2132.7 cells per millimeter squared	1390.6 cells per millimeter squared	2227.0 cells per millimeter squared	1995.7 cells per millimeter squared	489.7 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 25th percentile	2132.7 cells per millimeter squared	1390.6 cells per millimeter squared	2227.0 cells per millimeter squared	1995.7 cells per millimeter squared	489.7 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 50th percentile	2132.7 cells per millimeter squared	1390.6 cells per millimeter squared	2227.0 cells per millimeter squared	2103.2 cells per millimeter squared	1477.5 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 75th percentile	2132.7 cells per millimeter squared	1390.6 cells per millimeter squared	2227.0 cells per millimeter squared	2210.7 cells per millimeter squared	2465.2 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 95th percentile	2132.7 cells per millimeter squared	1390.6 cells per millimeter squared	2227.0 cells per millimeter squared	2210.7 cells per millimeter squared	2465.2 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8) 100th percentile	2132.7 cells per millimeter squared	1390.6 cells per millimeter squared	2227.0 cells per millimeter squared	2210.7 cells per millimeter squared	2465.2 cells per millimeter squared	—

PRIMARY outcome

Timeframe: Month 108 (Year 9) postoperative

Population: All enrolled with data at visit

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=40 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 0 percentile	516.5 cells per millimeter squared	1373.0 cells per millimeter squared	569.0 cells per millimeter squared	449.5 cells per millimeter squared	479.2 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 5th percentile	516.5 cells per millimeter squared	1373.0 cells per millimeter squared	569.0 cells per millimeter squared	449.5 cells per millimeter squared	479.2 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 25th percentile	1848.4 cells per millimeter squared	1575.9 cells per millimeter squared	2106.0 cells per millimeter squared	803.8 cells per millimeter squared	514.8 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 50th percentile	2272.0 cells per millimeter squared	1796.7 cells per millimeter squared	2262.3 cells per millimeter squared	2037.3 cells per millimeter squared	633.6 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 75th percentile	2515.5 cells per millimeter squared	2080.3 cells per millimeter squared	2331.2 cells per millimeter squared	2483.8 cells per millimeter squared	1283.2 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 95th percentile	2814.0 cells per millimeter squared	2345.8 cells per millimeter squared	2784.7 cells per millimeter squared	2772.0 cells per millimeter squared	1949.5 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9) 100th percentile	2814.0 cells per millimeter squared	2345.8 cells per millimeter squared	2784.7 cells per millimeter squared	2772.0 cells per millimeter squared	1949.5 cells per millimeter squared	—

PRIMARY outcome

Timeframe: Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can vary depending on age and individual variation. A higher value indicates better corneal health and function. A lower value suggests potential endothelial dysfunction or damage. This analysis was performed data from visits in the COMPASS XXT study. Only data for subjects with rings visible on the CyPass MicroStent device and ECD data is presented. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=30 Participants CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=30 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=30 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring n=30 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings n=30 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 0 percentile	526.5 cells per millimeter squared	1512.7 cells per millimeter squared	647.7 cells per millimeter squared	477.0 cells per millimeter squared	353.3 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 5th percentile	526.5 cells per millimeter squared	1512.7 cells per millimeter squared	647.7 cells per millimeter squared	477.0 cells per millimeter squared	353.3 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 25th percentile	2262.8 cells per millimeter squared	1695.8 cells per millimeter squared	922.5 cells per millimeter squared	683.0 cells per millimeter squared	643.2 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 50th percentile	2408.8 cells per millimeter squared	2042.5 cells per millimeter squared	1709.8 cells per millimeter squared	2080.0 cells per millimeter squared	856.5 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 75th percentile	2507.7 cells per millimeter squared	2157.6 cells per millimeter squared	2250.2 cells per millimeter squared	2412.6 cells per millimeter squared	1269.8 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 95th percentile	3183.7 cells per millimeter squared	2371.3 cells per millimeter squared	2597.0 cells per millimeter squared	2637.3 cells per millimeter squared	1759.5 cells per millimeter squared	—
Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10) 100th percentile	3183.7 cells per millimeter squared	2371.3 cells per millimeter squared	2597.0 cells per millimeter squared	2637.3 cells per millimeter squared	1759.5 cells per millimeter squared	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

SSI events are additional surgical procedures performed after the initial placement of the CyPass micro-stent device to adjust its position or address issues related to its placement. SSI were noted through adverse event reporting, clinical evaluation, comprehensive documentation of outcome assessment and data analysis. A higher number of SSI events may indicate challenges or complications related to the initial placement of the CyPass device, technical difficulties during the initial surgery, device-related issues, or patient-specific factors contributing to the need for additional interventions. A lower number of SSI events may suggest that the initial device placement was successful and well-tolerated, with fewer complications or the need for adjustments. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Number of Secondary Surgical Intervention (SSI) Events to Modify the Device Position (eg, Repositioning, Trimming, Explantation)	0 secondary surgical interventions	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

CyPass micro-stent movement and/or malposition refers to issues related to the displacement or improper positioning of the CyPass Micro-Stent in the eye's drainage angle. The investigator qualitatively and subjectively assessed the position of the device by counting the visible number of rings of the device during a gonioscopic exam, which used a specialized lens to visually assess the position and stability of the CyPass device. Movement and/or malposition may suggest a greater risk of complications or inadequate treatment of glaucoma. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes With CyPass Micro-Stent Movement and/or Malposition	7.4 percentage of eyes Interval 2.1 to 17.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

A corneal adverse event is an undesirable occurrence related to the cornea, such as inflammation, edema, epithelial defects, or other complications. The number of corneal adverse events caused by the CyPass Micro-Stent was assessed from patient reporting, clinical observation and documentation during patients' follow-up visits. This analysis was performed using data from visits in the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Number of Corneal Adverse Events Caused by CyPass MicroStent	0 events	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Population: All enrolled with data at visit

Visual acuity was measured with correction in place using letter charts. BCVA \[synonymous with Best Corrected Distance Visual Acuity (BCDVA)\] at each visit was compared to the participant's best achieved BCVA recorded throughout the 10-year period after CyPass implantation. This analysis was performed using data from the COMPASS study, the COMPASS XT study, and the COMPASS XXT study. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 Participants CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Number of Events of Best Corrected Visual Acuity (BCVA) Loss of 10 Letters or More	21 events	—	—	—	—	—

PRIMARY outcome

Timeframe: Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Visual field mean deviation is a measure used in visual field testing to assess the overall sensitivity of a patient's vision compared to a standardized norm. The Humphrey automated perimeter with the 24-2 Swedish Interactive Thresholding Algorithm (SITA) standard testing method was used. Deviations were recorded in decibels. Normal deviation values are typically within 0 to -2 decibels (dB). A more negative number indicates decreased sensitivity and worsening of the overall visual field. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation Change from Screening Visit at Month 96 (Year 8)	2.379 decibel Standard Deviation 3.7404	—	—	—	—	—
Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation Change from Screening Visit at Month 108 (Year 9)	-1.176 decibel Standard Deviation 6.1884	—	—	—	—	—
Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation Change from Screening Visit at Month 120 (Year 10)	-2.321 decibel Standard Deviation 4.6707	—	—	—	—	—

PRIMARY outcome

Timeframe: Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

Visual field mean deviation is a measure used in visual field testing to assess the overall sensitivity of a patient's vision compared to a standardized norm. The Humphrey automated perimeter with the 24-2 SITA standard testing method was used. Deviations were recorded in decibels. Normal deviation values are typically within 0 to -2 decibels (dB). A more negative number indicates decreased sensitivity and worsening of the overall visual field. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) Change from Screening Visit at Month 96 (Year 8)	42.9 percentage of eyes	51.7 percentage of eyes	0.0 percentage of eyes	—	—	—
Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) Change from Screening Visit at Month 108 (Year 9)	9.8 percentage of eyes	51.2 percentage of eyes	39.0 percentage of eyes	—	—	—
Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB) Change from Screening Visit at Month 120 (Year 10)	10.9 percentage of eyes	45.7 percentage of eyes	43.5 percentage of eyes	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

CCT is a measurement of the thickness of the cornea at its center and is assessed using a procedure called corneal pachymetry. A high CCT (thick cornea) indicates a central cornea thicker than average and may be associated with conditions such as corneal edema, Fuchs' dystrophy, or ocular hypertension. A low CCT (thin cornea) indicates a central cornea thinner than average and may be a risk factor for developing conditions such as glaucoma. A negative change value indicates a decrease in corneal thickness. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 108 (Year 9)	0.0 microns Standard Deviation 22.84	—	—	—	—	—
Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 120 (Year 10)	4.1 microns Standard Deviation 25.09	—	—	—	—	—
Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation Change from Baseline at Month 96 (Year 8)	1.9 microns Standard Deviation 22.08	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Population: All enrolled with data at visit. Overall Number of Participants Analyzed is the number of unique subjects contributing any data to this analysis at any timepoint. In this follow-on study, not all subjects are eligible for all visits.

CCT is a measurement of the thickness of the cornea at its center and is assessed using a procedure called corneal pachymetry. A high CCT (thick cornea) indicates a central cornea thicker than average and may be associated with conditions such as corneal edema, Fuchs' dystrophy, or ocular hypertension. A low CCT (thin cornea) indicates a central cornea thinner than average and may be a risk factor for developing conditions such as glaucoma. A negative change value indicates a decrease in corneal thickness. This analysis was performed using data from the COMPASS study and data from the COMPASS XXT study. No hypothesis was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Cataract Surgery + CyPass n=54 eyes CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Lumen Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	Collar Only CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	1 Ring CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	2 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)	3 Rings CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 96 (Year 8)	1.9 microns Interval -18.6 to 22.3	—	—	—	—	—
Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 108 (Year 9)	0.0 microns Interval -7.1 to 7.1	—	—	—	—	—
Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval Change from Baseline at Month 120 (Year 10)	4.1 microns Interval -3.4 to 11.5	—	—	—	—	—

Adverse Events

Cataract Surgery + CyPass - Ocular Adverse Events

Serious events: 12 serious events

Other events: 31 other events

Deaths: 0 deaths

Cataract Surgery + CyPass - Systemic Adverse Events

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cataract Surgery + CyPass - Ocular Adverse Events n=54 participants at risk Adverse events reported in this group occurred in the study eye	Cataract Surgery + CyPass - Systemic Adverse Events n=54 participants at risk Adverse events reported in this group occurred systemically and include adverse events in the non-study eye
Eye disorders Visual Acuity Reduced	18.5% 10/54 • Number of events 10 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
General disorders Death	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	1.9% 1/54 • Number of events 1 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
Injury, poisoning and procedural complications Post Procedural Complication	1.9% 1/54 • Number of events 1 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
Nervous system disorders Visual Field Defect	3.7% 2/54 • Number of events 2 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
Surgical and medical procedures Trabeculectomy	3.7% 2/54 • Number of events 2 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
Surgical and medical procedures Trabeculoplasty	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	1.9% 1/54 • Number of events 1 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.

Other adverse events

Other adverse events
Measure	Cataract Surgery + CyPass - Ocular Adverse Events n=54 participants at risk Adverse events reported in this group occurred in the study eye	Cataract Surgery + CyPass - Systemic Adverse Events n=54 participants at risk Adverse events reported in this group occurred systemically and include adverse events in the non-study eye
Eye disorders Corneal Endothelial Cell Loss	11.1% 6/54 • Number of events 6 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
Eye disorders Visual Acuity Reduced	25.9% 14/54 • Number of events 14 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
Injury, poisoning and procedural complications Device Placement Issue	5.6% 3/54 • Number of events 3 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
Injury, poisoning and procedural complications Post Procedural Complication	7.4% 4/54 • Number of events 4 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.
Nervous system disorders Visual Field Defect	33.3% 18/54 • Number of events 18 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.	0.00% 0/54 • Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment. This analysis population includes all enrolled subjects. Safety was assessed at each visit. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more arms.

Additional Information

Director, Clinical Projects - CDMA Surgical

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER