Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

Glaukos Corporation505 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

505

Conditions

Primary Open-angle Glaucoma

Interventions

iStent injectDEVICE

Implantation of two GTS400 stents using G2-M-IS iStent inject

Cataract surgeryPROCEDURE

Cataract surgery alone

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Eye Centers of Racine and Kenosha

Racine, Wisconsin, United States

Outcomes

Primary Outcomes

≥ 20% Reduction in Intraocular Pressure (IOP)

Time frame: Baseline and Month 24

Secondary Outcomes

Diurnal IOP Reduction from Baseline

Time frame: Baseline and Month 24

Data from ClinicalTrials.gov

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