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Completed

NCT Number: NCT01461291

Multicenter Study Using 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.

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Key information

Conditions

Primary Open-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Centers of Racine and Kenosha

Racine, Wisconsin, 53405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iStent inject

Device

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

cataract surgery

Procedure

Cataract surgery alone

Primary outcomes

  1. ≥ 20% Reduction in Intraocular Pressure (IOP)

    Time frame: Baseline and Month 24

Secondary outcomes

  1. Diurnal IOP Reduction from Baseline

    Time frame: Baseline and Month 24

Other outcomes

  1. Safety follow-up post-PMA to be through 36 months

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Oct 28, 2011
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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