Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort
- Conditions
- Primary Open Angle Glaucoma
- Registration Number
- NCT01836042
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.
- Detailed Description
The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study
- Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
- Patients not previously enrolled in Glaukos Study GC-003
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Sight-threatening Adverse Events 80 Month average The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.
- Secondary Outcome Measures
Name Time Method