Trial Outcomes & Findings for Post Approval Study of the CyPass System (NCT NCT03273907)

Last Updated: 2024-02-16

Results Overview

Device-related complications, as specified in the protocol, included: * Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass. * Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that: * The device is not in the supraciliary space, or * Clinical sequela resulting from device position including, but not limited to: * Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation) * Corneal endothelial touch by device * Corneal edema leading to loss of BCDVA \> 2 lines at the last postoperative visit, in comparison with preoperative BCDVA * Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up).

Recruitment status

TERMINATED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

Up to Month 36 postoperative

Results posted on

2024-02-16

Participant Flow

Participants were enrolled at 20 investigative sites located in the United States. Due to the CyPass voluntary global market withdrawal, enrollment was permanently suspended for this study starting 29 August 2018.

Of the 79 enrolled, 36 subjects were exited from the study prior to attempted implantation with the CyPass Micro-Stent. This reporting group includes all subjects with attempted implantation (43). Only one eye per subject was implanted.

Participant milestones

Participant milestones
Measure	CyPass System CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Overall Study STARTED	43
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	CyPass System CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Overall Study Death	1
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2
Overall Study COVID 19	2

Baseline Characteristics

Post Approval Study of the CyPass System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CyPass System n=43 Participants CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Age, Continuous	71.4 years STANDARD_DEVIATION 5.31 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Month 36 postoperative

Population: Intent-to-Treat (ITT) Analysis Set

Outcome measures

Outcome measures
Measure	CyPass System n=43 eyes CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36	2.3 percentage of eyes

SECONDARY outcome

Timeframe: Baseline, Month 36 postoperative

Population: ITT Analysis Set with data at visit

Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement.

Outcome measures

Outcome measures
Measure	CyPass System n=34 eyes CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Mean Change in IOP From Baseline at Month 36	-3.71 mmHg Standard Deviation 4.881

SECONDARY outcome

Timeframe: Baseline, Month 36 postoperative

Population: ITT Analysis Set with data at visit

Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	CyPass System n=34 eyes CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36	41.2 percentage of eyes Interval 24.6 to 59.3

SECONDARY outcome

Timeframe: Month 36 postoperative

Population: ITT Analysis Set with data at visit

Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). Only one eye per subject was implanted.

Outcome measures

Outcome measures
Measure	CyPass System n=34 eyes CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36	61.8 percentage of eyes Interval 43.6 to 77.8

SECONDARY outcome

Timeframe: Up to Month 36 postoperative

Population: ITT Analysis Set

Sight-threatening adverse events, as specified in the protocol, included: * Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more * Endophthalmitis * Corneal decompensation * Retinal detachment * Severe choroidal hemorrhage or detachment * Aqueous misdirection. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE.

Outcome measures

Outcome measures
Measure	CyPass System n=43 eyes CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Percentage of Eyes With Sight-threatening Adverse Events (AEs)	2.3 percentage of eyes Interval 0.1 to 12.3

SECONDARY outcome

Timeframe: Up to Month 36 postoperative

Population: ITT Analysis Set

A secondary surgical intervention may have occurred for any of the following reasons: * CyPass device explantation associated with CyPass placement and stability * CyPass device explantation NOT associated with CyPass placement and stability * Unplanned ocular surgical reintervention associated with CyPass placement and stability * Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol). Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE

Outcome measures

Outcome measures
Measure	CyPass System n=43 eyes CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)	7.0 percentage of eyes Interval 1.5 to 19.1

SECONDARY outcome

Timeframe: Up to Month 36 postoperative

Population: ITT Analysis Set

A secondary surgical intervention may have occurred for either of the following reasons: * CyPass device explantation associated with CyPass placement and stability * Unplanned ocular surgical reintervention associated with CyPass placement and stability. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE

Outcome measures

Outcome measures
Measure	CyPass System n=43 eyes CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability	2.3 percentage of eyes Interval 0.1 to 12.3

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CyPass Study Eye

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

CyPass Systemic

Serious events: 7 serious events

Other events: 21 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=43 participants at risk Events reported in this group occurred prior to attempted implantation with the test article	CyPass Study Eye n=43 participants at risk Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye	CyPass Systemic n=43 participants at risk Events reported in this group occurred after attempted implantation with the test article and include systemic adverse events plus ocular events in the non-study eye
Cardiac disorders Cardiac failure	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Cardiac disorders Cardiac failure congestive	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Eye disorders Visual acuity reduced	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Hepatobiliary disorders Cholecystitis	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Investigations Intraocular pressure increased	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	4.7% 2/43 • Number of events 2 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Investigations Paracentesis eye	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	4.7% 2/43 • Number of events 2 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Nervous system disorders Visual field defect	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Renal and urinary disorders Renal failure	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Surgical and medical procedures Glaucoma drainage device placement	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.

Other adverse events

Other adverse events
Measure	Pretreatment n=43 participants at risk Events reported in this group occurred prior to attempted implantation with the test article	CyPass Study Eye n=43 participants at risk Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye	CyPass Systemic n=43 participants at risk Events reported in this group occurred after attempted implantation with the test article and include systemic adverse events plus ocular events in the non-study eye
Eye disorders Posterior capsule opacification	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	14.0% 6/43 • Number of events 6 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Eye disorders Visual acuity reduced	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	7.0% 3/43 • Number of events 3 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Investigations Intraocular pressure increased	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	9.3% 4/43 • Number of events 4 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	7.0% 3/43 • Number of events 3 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Nervous system disorders Visual field defect	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	7.0% 3/43 • Number of events 4 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	2.3% 1/43 • Number of events 1 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Surgical and medical procedures Cataract operation	7.0% 3/43 • Number of events 3 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	0.00% 0/43 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.	44.2% 19/43 • Number of events 19 • Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.

Additional Information

CDMA Clinical Lead, 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.
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