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

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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.

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.

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
We found this trial at
1
site
Racine, Wisconsin 53405
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mi
from
Racine, WI
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