Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 3/10/2019 |
| Start Date: | November 30, 2011 |
| End Date: | December 2019 |
A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
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.
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.
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.
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.
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
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