Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery
Not Applicable
Completed
- Conditions
- Primary Open-angle Glaucoma
- Interventions
- Procedure: Cataract surgeryDevice: iStent supra
- Registration Number
- NCT01461278
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
- Detailed Description
This is an IDE trial to evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 505
Inclusion Criteria
- Mild to moderate open-angle glaucoma
- Characteristics consistent with mild to moderate glaucoma
- Use of one (1) to three (3) medications at time of screening exam
Exclusion Criteria
- Pigmentary or pseudoexfoliative glaucoma
- Prior incisional glaucoma surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cataract surgery Cataract surgery - Cataract surgery plus iStent supra Cataract surgery - Cataract surgery plus iStent supra iStent supra -
- Primary Outcome Measures
Name Time Method ≥ 20% Reduction in Intraocular Pressure (IOP) Baseline and Month 24
- Secondary Outcome Measures
Name Time Method Diurnal IOP Reduction from Baseline Baseline and Month 24
Trial Locations
- Locations (1)
Eye Centers of Racine and Kenosha
🇺🇸Racine, Wisconsin, United States