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A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial (COMPASS-XT)

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ClinicalTrials.gov Identifier: NCT02700984
Recruitment Status : Completed
First Posted : March 7, 2016
Results First Posted : May 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Transcend Medical, Inc.
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Primary Open Angle Glaucoma (POAG)
Interventions Device: CyPass Micro-Stent
Procedure: Cataract Surgery
Enrollment 282
Recruitment Details Subjects were recruited from 23 study sites located in the US.
Pre-assignment Details This reporting group includes all enrolled subjects (282).
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial) Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Period Title: Overall Study
Started [1] 215 67
Completed [2] 200 53
Not Completed 15 14
Reason Not Completed
Death             2             1
Lost to Follow-up             2             1
Physician Decision             0             1
Withdrawal by Subject             8             9
Reason not specified             3             2
[1]
All enrolled subjects
[2]
All subjects who completed the 60-month assessment
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only Total
Hide Arm/Group Description CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial) Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation Total of all reporting groups
Overall Number of Baseline Participants 215 67 282
Hide Baseline Analysis Population Description
This analysis population includes all enrolled subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 215 participants 67 participants 282 participants
69.4  (7.9) 70.8  (7.5) 69.7  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 67 participants 282 participants
Female
116
  54.0%
37
  55.2%
153
  54.3%
Male
99
  46.0%
30
  44.8%
129
  45.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 67 participants 282 participants
Hispanic or Latino
11
   5.1%
4
   6.0%
15
   5.3%
Not Hispanic or Latino
204
  94.9%
63
  94.0%
267
  94.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 67 participants 282 participants
White
191
  88.8%
58
  86.6%
249
  88.3%
Black or African American
21
   9.8%
7
  10.4%
28
   9.9%
American Indian or Alaska Native
1
   0.5%
1
   1.5%
2
   0.7%
Asian
2
   0.9%
1
   1.5%
3
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group
Hide Description 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.
Time Frame Up to Month 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects with available data
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 215 67
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
215 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: rate (percentage) of adverse events
0.19
(0.05 to 0.76)
0.30
(0.04 to 2.03)
2.Secondary Outcome
Title Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Hide Description 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.
Time Frame Baseline, Month 12, 24, 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects with available data
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 215 67
Measure Type: Number
Unit of Measure: subjects
20/20 or Better @ Baseline Number Analyzed 215 participants 67 participants
14 2
20/25 or Better @ Baseline Number Analyzed 215 participants 67 participants
55 17
20/32 or Better @ Baseline Number Analyzed 215 participants 67 participants
106 34
20/40 or Better @ Baseline Number Analyzed 215 participants 67 participants
171 52
Worse than 20/40 @ Baseline Number Analyzed 215 participants 67 participants
44 15
20/20 or Better @ Month 12 Number Analyzed 214 participants 66 participants
145 49
20/25 or Better @ Month 12 Number Analyzed 214 participants 66 participants
192 59
20/32 or Better @ Month 12 Number Analyzed 214 participants 66 participants
212 64
20/40 or Better @ Month 12 Number Analyzed 214 participants 66 participants
213 66
Worse than 20/40 @ Month 12 Number Analyzed 214 participants 66 participants
1 0
20/20 or Better @ Month 24 Number Analyzed 215 participants 67 participants
150 46
20/25 or Better @ Month 24 Number Analyzed 215 participants 67 participants
198 60
20/32 or Better @ Month 24 Number Analyzed 215 participants 67 participants
213 63
20/40 or Better @ Month 24 Number Analyzed 215 participants 67 participants
215 66
Worse than 20/40 @ Month 24 Number Analyzed 215 participants 67 participants
0 1
20/20 or Better @ Month 36 Number Analyzed 134 participants 43 participants
72 27
20/25 or Better @ Month 36 Number Analyzed 134 participants 43 participants
105 34
20/32 or Better @ Month 36 Number Analyzed 134 participants 43 participants
121 42
20/40 or Better @ Month 36 Number Analyzed 134 participants 43 participants
132 43
Worse than 20/40 @ Month 36 Number Analyzed 134 participants 43 participants
2 0
20/20 or Better @ Month 48 Number Analyzed 174 participants 52 participants
102 33
20/25 or Better @ Month 48 Number Analyzed 174 participants 52 participants
143 43
20/32 or Better @ Month 48 Number Analyzed 174 participants 52 participants
165 50
20/40 or Better @ Month 48 Number Analyzed 174 participants 52 participants
172 52
Worse than 20/40 @ Month 48 Number Analyzed 174 participants 52 participants
2 0
20/20 or Better @ Month 60 Number Analyzed 196 participants 51 participants
126 33
20/25 or Better @ Month 60 Number Analyzed 196 participants 51 participants
165 45
20/32 or Better @ Month 60 Number Analyzed 196 participants 51 participants
185 50
20/40 or Better @ Month 60 Number Analyzed 196 participants 51 participants
192 51
Worse than 20/40 @ Month 60 Number Analyzed 196 participants 51 participants
4 0
3.Secondary Outcome
Title Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye
Hide Description 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.
Time Frame Up to Month 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 215 67
Measure Type: Number
Unit of Measure: Subjects
60 13
4.Secondary Outcome
Title Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data at that visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 200 55
Measure Type: Number
Unit of Measure: subjects
None at Month 36 Number Analyzed 168 participants 50 participants
167 50
Mild at Month 36 Number Analyzed 168 participants 50 participants
1 0
None at Month 48 Number Analyzed 190 participants 55 participants
190 55
None at Month 60 Number Analyzed 200 participants 53 participants
199 53
Mild at Month 60 Number Analyzed 200 participants 53 participants
1 0
5.Secondary Outcome
Title Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data at that visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 200 55
Measure Type: Number
Unit of Measure: subjects
None at Month 36 Number Analyzed 168 participants 50 participants
159 48
Mild at Month 36 Number Analyzed 168 participants 50 participants
8 2
Moderate at Month 36 Number Analyzed 168 participants 50 participants
1 0
None at Month 48 Number Analyzed 190 participants 55 participants
181 52
Mild at Month 48 Number Analyzed 190 participants 55 participants
8 3
Moderate at Month 48 Number Analyzed 190 participants 55 participants
1 0
None at Month 60 Number Analyzed 200 participants 53 participants
191 51
Mild at Month 60 Number Analyzed 200 participants 53 participants
6 2
Moderate at Month 60 Number Analyzed 200 participants 53 participants
3 0
6.Secondary Outcome
Title Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data at that visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 200 55
Measure Type: Number
Unit of Measure: subjects
0 - < 1 cell at Month 36 Number Analyzed 168 participants 50 participants
168 50
0 - < 1 cell at Month 48 Number Analyzed 190 participants 55 participants
189 55
1 - 5 cells at Month 48 Number Analyzed 190 participants 55 participants
1 0
0 - < 1 cell at Month 60 Number Analyzed 200 participants 53 participants
200 53
7.Secondary Outcome
Title Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data at that visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 200 55
Measure Type: Number
Unit of Measure: subjects
None at Month 36 Number Analyzed 168 participants 50 participants
168 50
None at Month 48 Number Analyzed 190 participants 55 participants
190 55
None at Month 60 Number Analyzed 200 participants 53 participants
200 53
8.Secondary Outcome
Title Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data at that visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 200 55
Measure Type: Number
Unit of Measure: subjects
None at Month 36 Number Analyzed 164 participants 50 participants
163 49
Mild at Month 36 Number Analyzed 164 participants 50 participants
1 1
None at Month 48 Number Analyzed 190 participants 55 participants
189 55
Mild at Month 48 Number Analyzed 190 participants 55 participants
1 0
None at Month 60 Number Analyzed 200 participants 53 participants
198 53
Mild at Month 60 Number Analyzed 200 participants 53 participants
2 0
9.Secondary Outcome
Title Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data at that visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 200 55
Measure Type: Number
Unit of Measure: subjects
None at Month 36 Number Analyzed 164 participants 50 participants
163 50
Mild at Month 36 Number Analyzed 164 participants 50 participants
1 0
None at Month 48 Number Analyzed 189 participants 55 participants
188 55
Mild at Month 48 Number Analyzed 189 participants 55 participants
1 0
None at Month 60 Number Analyzed 200 participants 53 participants
200 53
10.Secondary Outcome
Title Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data at that visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 200 55
Measure Type: Number
Unit of Measure: subjects
None at Month 36 Number Analyzed 164 participants 50 participants
164 50
None at Month 48 Number Analyzed 190 participants 55 participants
190 55
None at Month 60 Number Analyzed 200 participants 53 participants
200 53
11.Secondary Outcome
Title Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data at that visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 200 55
Measure Type: Number
Unit of Measure: subjects
None at Month 36 Number Analyzed 166 participants 49 participants
114 42
Minimal at Month 36 Number Analyzed 166 participants 49 participants
27 3
Mild at Month 36 Number Analyzed 166 participants 49 participants
17 2
Moderate at Month 36 Number Analyzed 166 participants 49 participants
5 2
Unspecified at Month 36 Number Analyzed 166 participants 49 participants
3 0
None at Month 48 Number Analyzed 190 participants 55 participants
132 43
Minimal at Month 48 Number Analyzed 190 participants 55 participants
29 8
Mild at Month 48 Number Analyzed 190 participants 55 participants
25 4
Moderate at Month 48 Number Analyzed 190 participants 55 participants
4 0
None at Month 60 Number Analyzed 200 participants 53 participants
138 41
Minimal at Month 60 Number Analyzed 200 participants 53 participants
32 7
Mild at Month 60 Number Analyzed 200 participants 53 participants
26 4
Moderate at Month 60 Number Analyzed 200 participants 53 participants
4 1
12.Secondary Outcome
Title Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Number of eyes with available data and CyPass not explanted before visit
Arm/Group Title CyPass Visible Cypass Not Visible
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial) and visible by gonioscopy
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial) and not visible by gonioscopy
Overall Number of Participants Analyzed 177 177
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
177 177
Measure Type: Number
Unit of Measure: eyes
Month 36 Number Analyzed 48 eyes 48 eyes
47 1
Month 48 Number Analyzed 140 eyes 140 eyes
133 7
Month 60 Number Analyzed 177 eyes 177 eyes
162 15
13.Secondary Outcome
Title Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available data at each visit
Arm/Group Title Cataract Surgery + CyPass, Month 36 Cataract Surgery + CyPass, Month 48 Cataract Surgery + CyPass, Month 60 Cataract Surgery Only, Month 36 Cataract Surgery Only, Month 48 Cataract Surgery Only, Month 60
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 103 168 196 26 44 49
Measure Type: Number
Unit of Measure: subjects
Dry age-related macular degeneration Number Analyzed 103 participants 168 participants 196 participants 0 participants 0 participants 0 participants
0 0 1
Glaucomatous optic disc atrophy Number Analyzed 103 participants 168 participants 196 participants 26 participants 44 participants 49 participants
1 3 2 0 1 1
Macular degeneration Number Analyzed 103 participants 168 participants 196 participants 0 participants 0 participants 0 participants
0 0 1
Macular fibrosis Number Analyzed 103 participants 168 participants 196 participants 0 participants 0 participants 0 participants
0 1 1
Macular hole Number Analyzed 103 participants 168 participants 196 participants 0 participants 0 participants 0 participants
0 0 1
Macular oedema Number Analyzed 103 participants 168 participants 196 participants 0 participants 0 participants 0 participants
0 1 1
Neovascular age-related macular degeneration Number Analyzed 103 participants 168 participants 196 participants 0 participants 0 participants 0 participants
0 1 0
Optic atrophy Number Analyzed 103 participants 168 participants 196 participants 0 participants 0 participants 0 participants
0 0 1
Optic nerve disorder Number Analyzed 103 participants 168 participants 196 participants 0 participants 0 participants 0 participants
2 1 1
Retinal drusen Number Analyzed 103 participants 168 participants 196 participants 26 participants 44 participants 49 participants
0 0 1 1 1 0
Retinal haemorrhage Number Analyzed 0 participants 0 participants 0 participants 26 participants 44 participants 49 participants
0 1 0
14.Secondary Outcome
Title Change From Month 24 in Visual Field Mean Deviation
Hide Description 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.
Time Frame Month 24, 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subject eyes for which data was available at the visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 215 66
Mean (Standard Deviation)
Unit of Measure: dB
Month 24 Number Analyzed 215 participants 66 participants
-2.8  (3.3) -3.2  (4.0)
Change at Month 36 Number Analyzed 58 participants 17 participants
-0.0  (2.6) -0.2  (1.5)
Change at Month 48 Number Analyzed 142 participants 41 participants
-0.7  (2.3) -0.2  (2.3)
Change at Month 60 Number Analyzed 181 participants 47 participants
-0.8  (3.6) -0.6  (2.2)
15.Secondary Outcome
Title Change From Month 24 in Central Corneal Thickness
Hide Description 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.
Time Frame Month 24, 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Subject eyes for which data was available at the visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 215 67
Mean (Standard Deviation)
Unit of Measure: micrometers
Month 24 Number Analyzed 215 participants 67 participants
553.8  (35.1) 558.1  (31.9)
Change at Month 36 Number Analyzed 23 participants 8 participants
4.7  (16.3) -0.6  (10.6)
Change at Month 48 Number Analyzed 130 participants 37 participants
-1.4  (16.2) -3.8  (13.3)
Change at Month 60 Number Analyzed 175 participants 42 participants
-1.7  (18.8) -4.3  (14.1)
16.Secondary Outcome
Title Central Corneal Endothelial Cell Density (ECD) by Visit
Hide Description 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.
Time Frame Baseline, Month 3, 6, 12, 24, 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subject eyes for which data was available at the visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 214 67
Mean (Standard Deviation)
Unit of Measure: cells/mm2
Baseline Number Analyzed 214 participants 67 participants
2432.6  (369.7) 2434.5  (319.6)
Month 3 Number Analyzed 210 participants 65 participants
2199.2  (445.5) 2227.0  (422.4)
Month 6 Number Analyzed 211 participants 64 participants
2195.9  (431.4) 2209.2  (412.2)
Month 12 Number Analyzed 207 participants 66 participants
2194.3  (448.6) 2210.9  (383.8)
Month 24 Number Analyzed 213 participants 67 participants
2142.6  (423.3) 2218.9  (376.0)
Month 36 Number Analyzed 11 participants 5 participants
2148.1  (382.7) 2258.0  (338.9)
Month 48 Number Analyzed 116 participants 33 participants
1992.9  (460.8) 2303.2  (334.5)
Month 60 Number Analyzed 163 participants 40 participants
1931.2  (517.5) 2189.1  (375.6)
17.Secondary Outcome
Title Number of Subjects With CyPass Device Malposition, Dislodgement or Movement
Hide Description 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.
Time Frame Up to 60 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of subjects in the treatment group
Arm/Group Title Cataract Surgery + CyPass
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CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Overall Number of Participants Analyzed 215
Measure Type: Number
Unit of Measure: subjects
6
18.Secondary Outcome
Title Mean Reduction From Baseline in Intraocular Pressure (IOP)
Hide Description 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.
Time Frame Baseline, Month 36, 48, 60 postoperative
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All subject eyes for which data was available at the visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
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CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 215 67
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline Number Analyzed 215 participants 67 participants
24.5  (2.9) 24.8  (3.1)
Reduction at Month 36 Number Analyzed 155 participants 46 participants
8.9  (4.2) 8.2  (4.6)
Reduction at Month 48 Number Analyzed 182 participants 52 participants
8.4  (4.5) 7.9  (4.1)
Reduction at Month 60 Number Analyzed 200 participants 52 participants
8.4  (4.0) 8.0  (4.4)
19.Secondary Outcome
Title Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications
Hide Description 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.
Time Frame Baseline, Month 36, 48, 60 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All subject eyes for which data was available at the visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 215 67
Measure Type: Number
Unit of Measure: percentage of subjects
Month 36 Number Analyzed 159 participants 46 participants
57.9 41.3
Month 48 Number Analyzed 186 participants 52 participants
50.0 28.8
Month 60 Number Analyzed 200 participants 53 participants
46.0 32.1
20.Secondary Outcome
Title Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg
Hide Description 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.
Time Frame Month 36, 48, 60 postoperative
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Hide Analysis Population Description
All subject eyes with data available at the visit
Arm/Group Title Cataract Surgery + CyPass Cataract Surgery Only
Hide Arm/Group Description:
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Overall Number of Participants Analyzed 215 67
Measure Type: Number
Unit of Measure: percentage of subjects
Month 36 Number Analyzed 159 participants 46 participants
54.7 45.7
Month 48 Number Analyzed 186 participants 52 participants
46.2 30.8
Month 60 Number Analyzed 200 participants 53 participants
44.0 28.3
Time Frame Study enrollment through study completion (Month 60)
Adverse Event Reporting Description This analysis population includes all enrolled subjects. Safety was assessed at each visit.
 
Arm/Group Title CyPass Micro-Stent + Cataract Surgery (Study Eye) Cataract Surgery Only (Study Eye) CyPass Micro-Stent + Cataract Surgery (Systemic) Cataract Surgery Only (Systemic)
Hide Arm/Group Description All eyes implanted with CyPass Micro-Stent at the conclusion of cataract surgery. At risk population is reported in units of eye. All eyes wherein cataract surgery occurred. At risk population is reported in units of eye All subjects implanted with CyPass Micro-Stent at the conclusion of cataract surgery (non-study eye or not eye-related). All subjects who underwent cataract surgery (non-study eye or not eye-related).
All-Cause Mortality
CyPass Micro-Stent + Cataract Surgery (Study Eye) Cataract Surgery Only (Study Eye) CyPass Micro-Stent + Cataract Surgery (Systemic) Cataract Surgery Only (Systemic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/215 (0.00%)   0/67 (0.00%)   2/215 (0.93%)   1/67 (1.49%) 
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CyPass Micro-Stent + Cataract Surgery (Study Eye) Cataract Surgery Only (Study Eye) CyPass Micro-Stent + Cataract Surgery (Systemic) Cataract Surgery Only (Systemic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/215 (0.93%)   1/67 (1.49%)   17/215 (7.91%)   5/67 (7.46%) 
Cardiac disorders         
Arrhythmia  1  0/215 (0.00%)  0/67 (0.00%)  0/215 (0.00%)  1/67 (1.49%) 
Cardiac failure congestive  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Eye disorders         
Retinal detachment  1  0/215 (0.00%)  1/67 (1.49%)  0/215 (0.00%)  0/67 (0.00%) 
Visual acuity reduced  1  2/215 (0.93%)  0/67 (0.00%)  0/215 (0.00%)  0/67 (0.00%) 
Conjunctival bleb  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Retinal vein occlusion  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  1/67 (1.49%) 
Gastrointestinal disorders         
Dieulafoy's vascular malformation  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Oesophageal rupture  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
General disorders         
Death  1  0/215 (0.00%)  0/67 (0.00%)  2/215 (0.93%)  0/67 (0.00%) 
Injury, poisoning and procedural complications         
Incisional hernia  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Patella fracture  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Metabolism and nutrition disorders         
Hyperkalaemia  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthritis  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Osteoporosis  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer stage I  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Carcinoid tumour pulmonary  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Lung neoplasm malignant  1  0/215 (0.00%)  0/67 (0.00%)  0/215 (0.00%)  1/67 (1.49%) 
Renal cell carcinoma  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Squamous cell carcinoma of skin  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  1/67 (1.49%) 
Cervical myelopathy  1  0/215 (0.00%)  0/67 (0.00%)  0/215 (0.00%)  1/67 (1.49%) 
Renal and urinary disorders         
Renal failure  1  0/215 (0.00%)  0/67 (0.00%)  2/215 (0.93%)  0/67 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory failure  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
Vascular disorders         
Aortic aneurysm  1  0/215 (0.00%)  0/67 (0.00%)  1/215 (0.47%)  0/67 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CyPass Micro-Stent + Cataract Surgery (Study Eye) Cataract Surgery Only (Study Eye) CyPass Micro-Stent + Cataract Surgery (Systemic) Cataract Surgery Only (Systemic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/215 (20.00%)   10/67 (14.93%)   0/215 (0.00%)   0/67 (0.00%) 
Eye disorders         
Visual acuity reduced  1  24/215 (11.16%)  4/67 (5.97%)  0/215 (0.00%)  0/67 (0.00%) 
Investigations         
Visual field tests abnormal  1  22/215 (10.23%)  6/67 (8.96%)  0/215 (0.00%)  0/67 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr Clinical Project Lead, CDMA Surgical
Organization: Alcon Research
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02700984     History of Changes
Other Study ID Numbers: TMI-09-01-E
GLD122b-C001 ( Other Identifier: Alcon )
First Submitted: February 28, 2016
First Posted: March 7, 2016
Results First Submitted: April 10, 2019
Results First Posted: May 6, 2019
Last Update Posted: May 7, 2019