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

COMPLETEDNA

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

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

NCT01461291•Glaukos Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

January 16, 2012

Primary Completion Date

August 4, 2017

Completion Date

October 1, 2018

Last Updated

May 19, 2022

Enrollment

505

ACTUAL participants

Conditions

Primary Open-angle Glaucoma

Interventions

iStent inject

DEVICE

Cataract surgery

PROCEDURE

PRESERFLO® MicroShunt Extension Study

NCT04333433

Primary Open-angle Glaucoma

View study

UNKNOWN

Efficacy and Safety Outcomes of Optometrist Performed Selective Laser Trabeculoplasty (SLT)

NCT04036214

Primary Open-Angle Glaucoma, Unspecified EyeOcular Hypertension

View study

COMPLETEDNA

Modified Trabeculectomy With an ESST Versus Conventional SST for Management of Primary Open Angle Glaucoma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

PRESERFLO® MicroShunt Extension Study

Efficacy and Safety Outcomes of Optometrist Performed Selective Laser Trabeculoplasty (SLT)

Modified Trabeculectomy With an ESST Versus Conventional SST for Management of Primary Open Angle Glaucoma

Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients

Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6

Dose-Ranging Study of the Bimatoprost Ocular Insert