Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
NCT01841450 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2021-10-20
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 subjects with mild to moderate open-angle glaucoma.
Conditions
- Primary Open Angle Glaucoma
Interventions
- DEVICE
-
iStent
Implantation of one iStent in conjunction with cataract surgery
- PROCEDURE
-
Cataract surgery
Cataract surgery alone
Sponsors & Collaborators
-
Glaukos Corporation
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2021-08-31
- Completion
- 2021-11-30
Countries
- United States
Study Locations
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