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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-16

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Open-angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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iStent inject

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

Group Type EXPERIMENTAL

iStent inject

Intervention Type DEVICE

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

Cataract surgery

Cataract surgery alone

Group Type ACTIVE_COMPARATOR

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery alone

Interventions

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iStent inject

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

Intervention Type DEVICE

Cataract surgery

Cataract surgery alone

Intervention Type PROCEDURE

Eligibility Criteria

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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