Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Not Applicable
Completed
- Conditions
- Primary Open-angle Glaucoma
- Interventions
- Procedure: Cataract surgeryDevice: iStent inject
- Registration Number
- NCT01461291
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
- Detailed Description
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system 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/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 alone iStent inject iStent inject Implantation of two GTS400 stents using G2-M-IS iStent inject
- 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