Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
This trial is active, not recruiting.
|Condition||primary open angle glaucoma (poag)|
|Start date||December 2010|
|End date||July 2016|
|Trial size||120 participants|
|Trial identifier||NCT01252849, GCF-016|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
time frame: 12 Months
Mean diurnal IOP <18 mmHg at month 12
time frame: 12 months
Male or female participants at least 18 years old.
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
|Official title||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|
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