Status:
UNKNOWN
Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
Lead Sponsor:
Glaukos Corporation
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjec...
Detailed Description
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, i...
Eligibility Criteria
Inclusion
- mild to moderate primary open-angle glaucoma
- currently treated with ocular hypotensive medication
- pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
- subject scheduled to undergo cataract surgery
Exclusion
- primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
- retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01841450
Start Date
July 1 2013
End Date
November 1 2021
Last Update
October 20 2021
Active Locations (14)
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1
Irvine, California, United States, 92604
2
Montebello, California, United States, 90640
3
Aurora, Colorado, United States, 80045
4
Atlanta, Georgia, United States, 30342