Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/21/2016 |
Start Date: | July 2013 |
End Date: | April 2014 |
Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort
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.
Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos
Study GC-003.
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%.
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%.
Inclusion Criteria:
- Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to
participate in this extended follow-up study
Exclusion Criteria:
- 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
We found this trial at
26
sites
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