Trial Outcomes & Findings for A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial (NCT NCT02700984)
NCT ID: NCT02700984
Last Updated: 2024-01-24
Results Overview
Sight-threatening adverse events occurring in the study eye included, but were not limited to: BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection. The number of events at the end of Year 5 was divided by the number of eyes at risk at the beginning of Year 1 for a 5-year annualized rate. The 5-year annualized rate is reported as a percentage, with the last annual non-censored rate divided by 5. Inferential testing was not planned for this endpoint.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
282 participants
Primary outcome timeframe
Up to Month 60 postoperative
Results posted on
2024-01-24
Participant Flow
Subjects were recruited from 23 study sites located in the US.
This reporting group includes all enrolled subjects (282).
Participant milestones
| Measure |
Cataract Surgery + CyPass
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|
|
Overall Study
STARTED
|
215
|
67
|
|
Overall Study
COMPLETED
|
200
|
53
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
| Measure |
Cataract Surgery + CyPass
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
|
Overall Study
Reason not specified
|
3
|
2
|
Baseline Characteristics
A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial
Baseline characteristics by cohort
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 7.9 • n=93 Participants
|
70.8 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
69.7 years
STANDARD_DEVIATION 7.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
153 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
129 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
204 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
267 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
191 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
249 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to Month 60 postoperativePopulation: All enrolled subjects with available data
Sight-threatening adverse events occurring in the study eye included, but were not limited to: BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection. The number of events at the end of Year 5 was divided by the number of eyes at risk at the beginning of Year 1 for a 5-year annualized rate. The 5-year annualized rate is reported as a percentage, with the last annual non-censored rate divided by 5. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 eyes
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 eyes
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group
|
0.19 rate (percentage) of adverse events
Interval 0.05 to 0.76
|
0.30 rate (percentage) of adverse events
Interval 0.04 to 2.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24, 36, 48, 60 postoperativePopulation: All enrolled subjects with available data
Best corrected (with spectacles or other visual corrective devices) VA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 1 or 4 meters and determined by total number of letters read correctly. 20/20 Snellen is considered 'normal' vision. A larger denominator indicates a lower visual acuity. Baseline, Month 12, and Month 24 data derived from previous COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/20 or Better @ Month 36
|
72 subjects
|
27 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/25 or Better @ Month 36
|
105 subjects
|
34 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/20 or Better @ Baseline
|
14 subjects
|
2 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/25 or Better @ Baseline
|
55 subjects
|
17 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/32 or Better @ Baseline
|
106 subjects
|
34 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/40 or Better @ Baseline
|
171 subjects
|
52 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Worse than 20/40 @ Baseline
|
44 subjects
|
15 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/20 or Better @ Month 12
|
145 subjects
|
49 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/25 or Better @ Month 12
|
192 subjects
|
59 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/32 or Better @ Month 12
|
212 subjects
|
64 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/40 or Better @ Month 12
|
213 subjects
|
66 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Worse than 20/40 @ Month 12
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/20 or Better @ Month 24
|
150 subjects
|
46 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/25 or Better @ Month 24
|
198 subjects
|
60 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/32 or Better @ Month 24
|
213 subjects
|
63 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/40 or Better @ Month 24
|
215 subjects
|
66 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Worse than 20/40 @ Month 24
|
0 subjects
|
1 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/32 or Better @ Month 36
|
121 subjects
|
42 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/40 or Better @ Month 36
|
132 subjects
|
43 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Worse than 20/40 @ Month 36
|
2 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/20 or Better @ Month 48
|
102 subjects
|
33 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/25 or Better @ Month 48
|
143 subjects
|
43 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/32 or Better @ Month 48
|
165 subjects
|
50 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/40 or Better @ Month 48
|
172 subjects
|
52 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Worse than 20/40 @ Month 48
|
2 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/20 or Better @ Month 60
|
126 subjects
|
33 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/25 or Better @ Month 60
|
165 subjects
|
45 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/32 or Better @ Month 60
|
185 subjects
|
50 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
20/40 or Better @ Month 60
|
192 subjects
|
51 subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Worse than 20/40 @ Month 60
|
4 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Month 60 postoperativePopulation: All enrolled subjects
Ocular adverse events in the study eye could include, but were not limited to, BCVA loss of 2 lines (10 letters) or more on the ETDRS chart in comparison with the best BCVA reported in Study Protocol TMI-09-01, endophthalmitis, corneal edema, and corneal decompensation. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye
|
60 Subjects
|
13 Subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subjects with available data at that visit
Corneal Edema (swelling of the cornea) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (transparent and clear or less than mild), Mild (dull glassy appearance), Moderate (Dull glassy appearance of epithelium with large number of vacuoles), and Severe (epithelial bullae and/or stromal edema, localized or diffuse, with or without stromal striae). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=200 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=55 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
None at Month 36
|
167 subjects
|
50 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
Mild at Month 36
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
None at Month 48
|
190 subjects
|
55 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
None at Month 60
|
199 subjects
|
53 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
Mild at Month 60
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subjects with available data at that visit
Corneal Staining (appearance of tissue disruption and other pathophysiological changes) and erosion (abrasion) were assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (no fluorescein staining of epithelium, OR less than mild), Mild (slight fluorescein staining confined to a small focus), Moderate (regionally dense fluorescein staining (1 mm or greater in diameter) with underlying structure moderately visible), and Severe (marked fluorescein staining or epithelial loss). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=200 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=55 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Mild at Month 48
|
8 subjects
|
3 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
None at Month 60
|
191 subjects
|
51 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Mild at Month 60
|
6 subjects
|
2 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
None at Month 48
|
181 subjects
|
52 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Moderate at Month 48
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
None at Month 36
|
159 subjects
|
48 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Mild at Month 36
|
8 subjects
|
2 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Moderate at Month 36
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Moderate at Month 60
|
3 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subjects with available data at that visit
Inflammatory anterior chamber cells (cells in the front portion of the eye) were assessed by the investigator during slit-lamp examination and reported in one of 6 categories according to cells per 1x1 mm slit: 0-\<1 cell, 1-5 cells, 6-15 cells, 16-25 cells, and 26-50 cells, and \>50 cells. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=200 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=55 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells
0 - < 1 cell at Month 36
|
168 subjects
|
50 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells
0 - < 1 cell at Month 48
|
189 subjects
|
55 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells
1 - 5 cells at Month 48
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells
0 - < 1 cell at Month 60
|
200 subjects
|
53 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subjects with available data at that visit
Anterior Chamber Flare (protein escaping from dilated vessels) was assessed by the investigator during slit-lamp examination and rated on a 5-point scale: None, Faint, Moderate (iris and lens details clear), Marked (iris and lens details hazy), and Intense (fibrin or plastic aqueous). The presence of flare is a sign of intraocular inflammation. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=200 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=55 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare
None at Month 60
|
200 subjects
|
53 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare
None at Month 36
|
168 subjects
|
50 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare
None at Month 48
|
190 subjects
|
55 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subjects with available data at that visit
Iris Atrophy/Erosion (deterioration) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=200 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=55 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
None at Month 60
|
198 subjects
|
53 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
None at Month 36
|
163 subjects
|
49 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
Mild at Month 36
|
1 subjects
|
1 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
None at Month 48
|
189 subjects
|
55 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
Mild at Month 48
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
Mild at Month 60
|
2 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subjects with available data at that visit
Iris Peaking (one part of the iris pulled to a peak resulting in an irregular pupil) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=200 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=55 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking
None at Month 36
|
163 subjects
|
50 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking
Mild at Month 36
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking
None at Month 48
|
188 subjects
|
55 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking
Mild at Month 48
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking
None at Month 60
|
200 subjects
|
53 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subjects with available data at that visit
Iris Rubeosis (abnormal blood vessels (formed by neovascularization) found on the surface of the iris) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=200 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=55 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis
None at Month 36
|
164 subjects
|
50 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis
None at Month 48
|
190 subjects
|
55 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis
None at Month 60
|
200 subjects
|
53 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subjects with available data at that visit
PCO (cloudy layer of scar tissue behind the lens implant) Severity was assessed by the investigator during slit-lamp examination and rated on a 6-point scale: None, Minimal, Mild, Moderate, Severe, and Unspecified. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=200 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=55 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
None at Month 36
|
114 subjects
|
42 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Minimal at Month 36
|
27 subjects
|
3 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Moderate at Month 36
|
5 subjects
|
2 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Unspecified at Month 36
|
3 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
None at Month 48
|
132 subjects
|
43 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Minimal at Month 48
|
29 subjects
|
8 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Mild at Month 48
|
25 subjects
|
4 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Moderate at Month 48
|
4 subjects
|
0 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
None at Month 60
|
138 subjects
|
41 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Minimal at Month 60
|
32 subjects
|
7 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Mild at Month 60
|
26 subjects
|
4 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Moderate at Month 60
|
4 subjects
|
1 subjects
|
—
|
—
|
—
|
—
|
|
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Mild at Month 36
|
17 subjects
|
2 subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: Number of eyes with available data and CyPass not explanted before visit
For subjects in the CyPass group, gonioscopic examination was performed to assess the position of the CyPass Micro-Stent in the angle and with respect to the iris and the corneal endothelium. A visible CyPass Micro-Stent indicated a lack of adhesions (favorable). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=177 eyes
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=177 eyes
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only
Month 36
|
47 eyes
|
1 eyes
|
—
|
—
|
—
|
—
|
|
Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only
Month 48
|
133 eyes
|
7 eyes
|
—
|
—
|
—
|
—
|
|
Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only
Month 60
|
162 eyes
|
15 eyes
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: Subjects with available data at each visit
The dilated fundus examination was performed by the investigator to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. Clinically significant findings are reported categorically. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=103 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=168 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
n=196 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
n=26 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
n=44 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
n=49 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Dry age-related macular degeneration
|
0 subjects
|
0 subjects
|
1 subjects
|
—
|
—
|
—
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Retinal drusen
|
0 subjects
|
0 subjects
|
1 subjects
|
1 subjects
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Retinal haemorrhage
|
—
|
—
|
—
|
0 subjects
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Glaucomatous optic disc atrophy
|
1 subjects
|
3 subjects
|
2 subjects
|
0 subjects
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Macular degeneration
|
0 subjects
|
0 subjects
|
1 subjects
|
—
|
—
|
—
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Macular fibrosis
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
—
|
—
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Macular hole
|
0 subjects
|
0 subjects
|
1 subjects
|
—
|
—
|
—
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Macular oedema
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
—
|
—
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Neovascular age-related macular degeneration
|
0 subjects
|
1 subjects
|
0 subjects
|
—
|
—
|
—
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Optic atrophy
|
0 subjects
|
0 subjects
|
1 subjects
|
—
|
—
|
—
|
|
Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Optic nerve disorder
|
2 subjects
|
1 subjects
|
1 subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 24, 36, 48, 60 postoperativePopulation: All subject eyes for which data was available at the visit
Visual field (how much one can see to each side while focusing the eyes on a central point (peripheral vision)) deviations were obtained with a Humphrey automated perimeter using the 24-2 SITA standard testing method. Normal deviation values are typically within 0 to -2 decibels (dB) and become more negative as the overall field worsens. Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=66 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Change From Month 24 in Visual Field Mean Deviation
Change at Month 48
|
-0.7 dB
Standard Deviation 2.3
|
-0.2 dB
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
|
Change From Month 24 in Visual Field Mean Deviation
Month 24
|
-2.8 dB
Standard Deviation 3.3
|
-3.2 dB
Standard Deviation 4.0
|
—
|
—
|
—
|
—
|
|
Change From Month 24 in Visual Field Mean Deviation
Change at Month 36
|
-0.0 dB
Standard Deviation 2.6
|
-0.2 dB
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
|
Change From Month 24 in Visual Field Mean Deviation
Change at Month 60
|
-0.8 dB
Standard Deviation 3.6
|
-0.6 dB
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 24, 36, 48, 60 postoperativePopulation: Subject eyes for which data was available at the visit
Central corneal thickness was evaluated by Pachymetry and measured in micrometers (μm). A negative number indicates a decrease in corneal thickness (unfavorable). Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Change From Month 24 in Central Corneal Thickness
Month 24
|
553.8 micrometers
Standard Deviation 35.1
|
558.1 micrometers
Standard Deviation 31.9
|
—
|
—
|
—
|
—
|
|
Change From Month 24 in Central Corneal Thickness
Change at Month 36
|
4.7 micrometers
Standard Deviation 16.3
|
-0.6 micrometers
Standard Deviation 10.6
|
—
|
—
|
—
|
—
|
|
Change From Month 24 in Central Corneal Thickness
Change at Month 48
|
-1.4 micrometers
Standard Deviation 16.2
|
-3.8 micrometers
Standard Deviation 13.3
|
—
|
—
|
—
|
—
|
|
Change From Month 24 in Central Corneal Thickness
Change at Month 60
|
-1.7 micrometers
Standard Deviation 18.8
|
-4.3 micrometers
Standard Deviation 14.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 24, 36, 48, 60 postoperativePopulation: All subject eyes for which data was available at the visit
The endothelium maintains corneal hydration and reduced cell density can disrupt vision. Central endothelial cell counts were assessed using non-contact specular microscopy. Specular images were taken of the corneal endothelium and submitted to a reading center in order to standardize readings across all sites and optimize reading reliability. Baseline through Month 24 data were derived from COMPASS trial. A higher cell density indicates improvement. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=214 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Central Corneal Endothelial Cell Density (ECD) by Visit
Month 36
|
2148.1 cells/mm2
Standard Deviation 382.7
|
2258.0 cells/mm2
Standard Deviation 338.9
|
—
|
—
|
—
|
—
|
|
Central Corneal Endothelial Cell Density (ECD) by Visit
Month 48
|
1992.9 cells/mm2
Standard Deviation 460.8
|
2303.2 cells/mm2
Standard Deviation 334.5
|
—
|
—
|
—
|
—
|
|
Central Corneal Endothelial Cell Density (ECD) by Visit
Month 60
|
1931.2 cells/mm2
Standard Deviation 517.5
|
2189.1 cells/mm2
Standard Deviation 375.6
|
—
|
—
|
—
|
—
|
|
Central Corneal Endothelial Cell Density (ECD) by Visit
Baseline
|
2432.6 cells/mm2
Standard Deviation 369.7
|
2434.5 cells/mm2
Standard Deviation 319.6
|
—
|
—
|
—
|
—
|
|
Central Corneal Endothelial Cell Density (ECD) by Visit
Month 3
|
2199.2 cells/mm2
Standard Deviation 445.5
|
2227.0 cells/mm2
Standard Deviation 422.4
|
—
|
—
|
—
|
—
|
|
Central Corneal Endothelial Cell Density (ECD) by Visit
Month 6
|
2195.9 cells/mm2
Standard Deviation 431.4
|
2209.2 cells/mm2
Standard Deviation 412.2
|
—
|
—
|
—
|
—
|
|
Central Corneal Endothelial Cell Density (ECD) by Visit
Month 12
|
2194.3 cells/mm2
Standard Deviation 448.6
|
2210.9 cells/mm2
Standard Deviation 383.8
|
—
|
—
|
—
|
—
|
|
Central Corneal Endothelial Cell Density (ECD) by Visit
Month 24
|
2142.6 cells/mm2
Standard Deviation 423.3
|
2218.9 cells/mm2
Standard Deviation 376.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 months postoperativelyPopulation: Total number of subjects in the treatment group
Device position was a qualitative and subjective assessment by the investigator and evaluated based on visible number of rings of the device under the gonioscopic exam. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. This outcome measure was prespecified for Cataract Surgery + CyPass arm only.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Number of Subjects With CyPass Device Malposition, Dislodgement or Movement
|
6 subjects
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 36, 48, 60 postoperativePopulation: All subject eyes for which data was available at the visit
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher reduction from baseline (ie, a greater postitive number) indicates greater improvement. Baseline was derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Mean Reduction From Baseline in Intraocular Pressure (IOP)
Baseline
|
24.5 mmHg
Standard Deviation 2.9
|
24.8 mmHg
Standard Deviation 3.1
|
—
|
—
|
—
|
—
|
|
Mean Reduction From Baseline in Intraocular Pressure (IOP)
Reduction at Month 36
|
8.9 mmHg
Standard Deviation 4.2
|
8.2 mmHg
Standard Deviation 4.6
|
—
|
—
|
—
|
—
|
|
Mean Reduction From Baseline in Intraocular Pressure (IOP)
Reduction at Month 48
|
8.4 mmHg
Standard Deviation 4.5
|
7.9 mmHg
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
|
Mean Reduction From Baseline in Intraocular Pressure (IOP)
Reduction at Month 60
|
8.4 mmHg
Standard Deviation 4.0
|
8.0 mmHg
Standard Deviation 4.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 36, 48, 60 postoperativePopulation: All subject eyes for which data was available at the visit
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications
Month 48
|
50.0 percentage of subjects
|
28.8 percentage of subjects
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications
Month 36
|
57.9 percentage of subjects
|
41.3 percentage of subjects
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications
Month 60
|
46.0 percentage of subjects
|
32.1 percentage of subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 36, 48, 60 postoperativePopulation: All subject eyes with data available at the visit
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.
Outcome measures
| Measure |
Cataract Surgery + CyPass
n=215 Participants
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only
n=67 Participants
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery + CyPass, Month 60
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
|
Cataract Surgery Only, Month 36
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 48
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
Cataract Surgery Only, Month 60
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg
Month 36
|
54.7 percentage of subjects
|
45.7 percentage of subjects
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg
Month 48
|
46.2 percentage of subjects
|
30.8 percentage of subjects
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg
Month 60
|
44.0 percentage of subjects
|
28.3 percentage of subjects
|
—
|
—
|
—
|
—
|
Adverse Events
CyPass Micro-Stent + Cataract Surgery (Study Eye)
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Cataract Surgery Only (Study Eye)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
CyPass Micro-Stent + Cataract Surgery (Systemic)
Serious events: 17 serious events
Other events: 0 other events
Deaths: 2 deaths
Cataract Surgery Only (Systemic)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CyPass Micro-Stent + Cataract Surgery (Study Eye)
n=215 participants at risk
All eyes implanted with CyPass Micro-Stent at the conclusion of cataract surgery. At risk population is reported in units of eye.
|
Cataract Surgery Only (Study Eye)
n=67 participants at risk
All eyes wherein cataract surgery occurred. At risk population is reported in units of eye
|
CyPass Micro-Stent + Cataract Surgery (Systemic)
n=215 participants at risk
All subjects implanted with CyPass Micro-Stent at the conclusion of cataract surgery (non-study eye or not eye-related).
|
Cataract Surgery Only (Systemic)
n=67 participants at risk
All subjects who underwent cataract surgery (non-study eye or not eye-related).
|
|---|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
1.5%
1/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Eye disorders
Visual acuity reduced
|
0.93%
2/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
1.5%
1/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Eye disorders
Conjunctival bleb
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
1.5%
1/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
1.5%
1/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
1.5%
1/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
1.5%
1/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.93%
2/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.47%
1/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
General disorders
Death
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.93%
2/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
Other adverse events
| Measure |
CyPass Micro-Stent + Cataract Surgery (Study Eye)
n=215 participants at risk
All eyes implanted with CyPass Micro-Stent at the conclusion of cataract surgery. At risk population is reported in units of eye.
|
Cataract Surgery Only (Study Eye)
n=67 participants at risk
All eyes wherein cataract surgery occurred. At risk population is reported in units of eye
|
CyPass Micro-Stent + Cataract Surgery (Systemic)
n=215 participants at risk
All subjects implanted with CyPass Micro-Stent at the conclusion of cataract surgery (non-study eye or not eye-related).
|
Cataract Surgery Only (Systemic)
n=67 participants at risk
All subjects who underwent cataract surgery (non-study eye or not eye-related).
|
|---|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
11.2%
24/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
6.0%
4/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
|
Investigations
Visual field tests abnormal
|
10.2%
22/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
9.0%
6/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/215 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
0.00%
0/67 • Study enrollment through study completion (Month 60)
This analysis population includes all enrolled subjects. Safety was assessed at each visit.
|
Additional Information
Sr Clinical Project Lead, CDMA Surgical
Alcon Research
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