Status:
COMPLETED
Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort
Lead Sponsor:
Glaukos Corporation
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
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 ...
Eligibility Criteria
Inclusion
- Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01836042
Start Date
July 1 2013
End Date
April 1 2014
Last Update
April 15 2016
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Beverly Hills, California, United States, 90210
2
Petaluma, California, United States, 94954
3
Sacramento, California, United States, 95817
4
San Clemente, California, United States, 92673