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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150037 / PAS003 |
| Date Original Protocol Accepted |
04/09/2020
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| Date Current Protocol Accepted |
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| Study Name |
COMPASS XXT Post-Approval Study
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| Device Name |
CyPass Micro-Stent
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| Clinical Trial Number(s) |
NCT01085357
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up PAS (COMPASS XXT; protocol GLD122-P004) is a long-term safety, multicenter, observational study with no planned interventions. The aim of the study is to evaluate the long-term safety of CyPass® Micro-Stent glaucoma implant in subjects who have completed participation of the IDE clinical trial (COMPASS trial; G080209; TMI-09-01).
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| Study Population |
Subjects who completed the COMPASS trial, are able to understand the study requirements and willing to follow study instructions and are willing to return for required study follow-up visits.
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| Sample Size |
374 eyes of 374 subjects. This is based on the number of subjects implanted with the CyPass Micro-Stent, completed 24-month follow-up in study Protocol TMI-09-01 and will meet the study eligibility criteria.
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| Key Study Endpoints |
Safety outcome:
Rate of occurrence of sight-threatening adverse events (AEs)
Rate of occurrence of ocular AEs
Central and peripheral (nasal) endothelial cell density (ECD) measurements
Analyses of rate of loss and rate of low ECD (i.e., less than or equal to 1000 cells/mm2)
Assessment of stabilization of endothelial cell loss (ECL)
Corneal sequelae associated with ECL
Association between peripheral and central ECD count and number of observed rings
Secondary surgical interventions (SSIs) to modify the device position (e.g., repositioning, trimming, explanation)
Effects of SSIs on central and peripheral ECD
CyPass® Micro-Stent movement and/or malposition
Corneal AEs (e.g., corneal decompensation, tube corneal touch, corneal edema, etc.) caused by CyPass® Micro-Stent
Losses in Best Corrected Visual Acuity (BCVA) greater than or equal to 10 letters
Change in visual field mean deviation (MD)
Change in central corneal thickness
Effectiveness outcomes:
Mean intraocular pressure (IOP)
Proportion of subjects with a 20% or better reduction in IOP from COMPASS washed out baseline and on zero medication
Proportion of subjects with mean IOP less than or equal to 18 mmHg
Number of ocular hypotensive medications
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| Follow-up Visits and Length of Follow-up |
10 years after CyPass stent implantation
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
54
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| Actual Number of Sites Enrolled |
13
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| Patient Follow-up Rate |
Of the 374 subjects implanted in the COMPASS study, 210 (56.1%) were eligible for recruitment. Of these, 156/210 (74.3%) were unavailable (e.g., not qualified, deceased, declined enrollment, no reason provided) and 54/210 (25.7%) agreed to enroll. Forty-six of 210 subjects (21.9% of the total number of subjects available for recruitment) completed the study.
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| Final Safety Findings |
The mean central ECD at baseline (N=373) was 2429.1 cells/mm^2. Mean central ECD was 1668.80 cells/mm^2 at 108 months (42/53) and 1574.73 cells/mm^2 at 120 months (38/53) postoperative. Mean peripheral ECD was 1739.44 cells/mm^2 for available participants at 108 months (42/53) and 1688.74 cells/mm^2 at 120 months (30/53) postoperative. The mean peripheral ECD was not available at baseline. The bullets below represent the changes in central ECD. There were no subjects available at 6 and 7 years. Due to small sample size (N=7), there is no meaningful information that can be drawn from the data at 8 years.
At 3 months, 9.6% (5/52) of the participants had ECL >30%.
At 2 years, 9.4% (5/52) had loss >30%, and one (1/53) had ECD < 1000 cells/mm^2.
At 5 years, the proportion of participants with ECD < 1000 cells/mm^2 increased to 6.7% (3/45) and the proportion of those with ECL >30% increased to 26.7% (12/45).
At 9 years, the proportion of participants with ECD <1000 cells/mm^2 increased to 26.2% (11/42) and the proportion of those with ECL >30% increased to 40.5% (n=17/42).
At 10 years, the proportion of participants with ECD <1000 cells/mm^2 increased to 31.6% (12/38) and the proportion of those with ECL >30% increased to 52.6% (n=20/38).
Sixteen ocular serious AEs (SAEs) were reported in 12 participants. Persistent best-corrected distance visual acuity (BCDVA) loss of 3 lines or more was reported in 21.7% (10/46) of the study participants. In two of these cases, the persistent BCDVA loss of 3 lines or more was assessed as related to the CyPass device (serious adverse device events [SADEs]). The other ocular SAEs were trabeculectomy (4.3% [2/46]), visual field defect (4.3% [2/46]), post-procedural complication (2.2% [1/46]), and trabeculoplasty (2.2% [1/46]).
Ocular adverse events (AEs) occurring over 5% in the study were reduced visual acuity (45.7% [21/46]), visual field defect (43.5% [20/46]), corneal endothelial cell loss (13.0% [6/46]), post-procedural complication (device obstruction; 10.9% [5/46]), device placement issues (device malposition resulting in progressive ECL; 6.5% [3/46]). Non-optimal position of the device without associated clinical sequelae was reported in 50% (23/46) of participants. Worsening of visual field mean deviation (MD) >2.5 dB was reported in 39.1% (18/46) of participants at Month 120.
Three participants underwent secondary surgical interventions (SSIs) to lower intraocular pressure (IOP) (trabeculectomy, glaucoma drainage device implantation after prior trabeculectomy during the COMPASS XT study, selective laser trabeculoplasty [SLT]). In the interim period between exit from the COMPASS XT study and participation in the COMPASS XXT study, one participant was reported with device malposition and two participants underwent device trimming due to corneal edema and corneal endothelial cell loss.
These data highlight that the elevated rate of ECL continued even at 10 years after implantation without signs of stabilization.
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| Final Effect Findings |
Effectiveness outcomes in this study are considered exploratory. Mean intraocular pressure (IOP) for the study participants was below the baseline mean (24.98 mm Hg, measured at the screening visit in the COMPASS study), ranging between 15.85 – 17.12 mm Hg at the postoperative visits in the study. At 120 months, participants had a mean IOP reduction of 8.90 mm Hg (35.04% decrease from baseline). At 120 months postoperative, 17.4% (8/46) of the participants who were not taking IOP-reducing medications achieved IOP reduction greater than or equal to 20% compared to their preoperative unmedicated IOP. At 120 months, mean IOP for 73.9% (34/46) of study participants was 18 mm Hg or lower
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| Study Strengths & Weaknesses |
Enrollment was significantly underachieved due to low site participation and unavailability of the previously implanted cohort. Protocol deviations were reported for 96.3% of enrolled participants; 41% of these deviations were related to missing assessments or incorrectly performed assessments. Visualization of the device on gonioscopy was reported for only 35 participants. These issues impact the reliability of the information reported from the study, including whether gonioscopy alone is sufficient method to monitor for device position
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| Recommendations for Labeling Changes |
The applicant voluntarily removed the CyPass Micro-Stent from the global market on August 29, 2018. Given that the device is not available for distribution, labeling changes are not recommended. However, on July 9, 2025, the applicant notified their customers of the results of this PAS and of their intent to not re-introduce the device into the market. Healthcare professionals should discuss with their patients the results of the COMPASS XXT 10-year PAS and available options that patients may want to pursue.
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