NCT01252849CompletedNot Applicable
A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Glaukos Corporation
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosed with primary open-angle glaucoma (POAG)
- •Subject on two topical hypotensive medications
Exclusion Criteria
- •Traumatic, uveitic, neovascular, or angle closure glaucoma
- •Fellow eye already enrolled
Arms & Interventions
First Arm: One iStent, medication
Experimental
Device: One iStent, medication
Intervention: iStent (Device)
Second Arm: Two iStents, medication
Experimental
Device: Two iStent devices, medication
Intervention: iStent (Device)
Third Arm: Three iStents, medication
Experimental
Device: Three iStent devices, medication
Intervention: iStent (Device)
Outcomes
Primary Outcomes
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
Time Frame: 12 Months
Secondary Outcomes
- Mean diurnal IOP <18 mmHg at month 12(12 months)
Investigators
Study Sites (1)
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