N/A
Completed N=282
A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial
Primary Open Angle Glaucoma (POAG)
Source: ClinicalTrials.gov NCT02700984 ↗
Enrolled (actual)
282
Serious AEs
4.4%
Results posted
May 2019
Primary outcomePrimary: 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group — 0.19; 0.30 rate (percentage) of adverse events
Summary
The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group |
0.19; 0.30 | — |
| SECONDARY Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit |
14; 2; 55; 17; 106; 34 | — |
| SECONDARY Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye |
60; 13 | — |
| SECONDARY Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema |
167; 50; 1; 0; 190; 55 | — |
| SECONDARY Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion |
159; 48; 8; 2; 1; 0 | — |
| SECONDARY Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells |
168; 50; 189; 55; 1; 0 | — |
| SECONDARY Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare |
168; 50; 190; 55; 200; 53 | — |
| SECONDARY Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion |
163; 49; 1; 1; 189; 55 | — |
| SECONDARY Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking |
163; 50; 1; 0; 188; 55 | — |
| SECONDARY Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis |
164; 50; 190; 55; 200; 53 | — |
| SECONDARY Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity |
114; 42; 27; 3; 17; 2 | — |
| SECONDARY Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only |
47; 1; 133; 7; 162; 15 | — |
| SECONDARY Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations |
0; 0; 1; 1; 3; 2 | — |
| SECONDARY Change From Month 24 in Visual Field Mean Deviation |
-2.8; -3.2; -0.0; -0.2; -0.7; -0.2 | — |
| SECONDARY Change From Month 24 in Central Corneal Thickness |
553.8; 558.1; 4.7; -0.6; -1.4; -3.8 | — |
| SECONDARY Central Corneal Endothelial Cell Density (ECD) by Visit |
2432.6; 2434.5; 2199.2; 2227.0; 2195.9; 2209.2 | — |
| SECONDARY Number of Subjects With CyPass Device Malposition, Dislodgement or Movement |
6 | — |
| SECONDARY Mean Reduction From Baseline in Intraocular Pressure (IOP) |
24.5; 24.8; 8.9; 8.2; 8.4; 7.9 | — |
| SECONDARY Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications |
57.9; 41.3; 50.0; 28.8; 46.0; 32.1 | — |
| SECONDARY Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg |
54.7; 45.7; 46.2; 30.8; 44.0; 28.3 | — |
Eligibility Criteria
Inclusion Criteria
- Completed the COMPASS Trial
- Understands study requirements and is willing to follow study instructions and return for study visits
Exclusion Criteria
- Systemic disease that would put subject health at risk and/or prevent completion of required study visits.
- Early termination from the COMPASS Trial.
Data sourced from ClinicalTrials.gov (NCT02700984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.