NCT01461291

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 505 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open-angle Glaucoma

Interventions

Type	Name	Description
DEVICE	iStent inject	Implantation of two GTS400 stents using G2-M-IS iStent inject
PROCEDURE	Cataract surgery	Cataract surgery alone

Timeline

• Start date: 2012-01-16
• Primary completion: 2017-08-04
• Completion: 2018-10-01
• First posted: 2011-10-28
• Last updated: 2022-05-19

Locations

1 site across 1 country: United States