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||January 2012|
|End date||September 2017|
|Trial size||251 participants|
|Trial identifier||NCT01517477, GCF-033|
The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Mean diurnal intraocular pressure (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|
Call for more information