Status:

COMPLETED

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

Lead Sponsor:

Glaukos Corporation

Conditions:

Primary Open-angle Glaucoma

Eligibility:

All Genders

45+ years

Phase:

NA

Brief 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...

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, compa...

Eligibility Criteria

Inclusion

  • 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

  • Pigmentary or pseudoexfoliative glaucoma
  • Prior incisional glaucoma surgery

Key Trial Info

Start Date :

January 16 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2018

Estimated Enrollment :

505 Patients enrolled

Trial Details

Trial ID

NCT01461291

Start Date

January 16 2012

End Date

October 1 2018

Last Update

May 19 2022

Active Locations (1)

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1

Eye Centers of Racine and Kenosha

Racine, Wisconsin, United States, 53405