NCT01841450

Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Detailed description

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	iStent	Implantation of one iStent in conjunction with cataract surgery
PROCEDURE	Cataract surgery	Cataract surgery alone

Timeline

• Start date: 2013-07-01
• Primary completion: 2021-08-01
• Completion: 2021-11-01
• First posted: 2013-04-26
• Last updated: 2021-10-20

Locations

14 sites across 1 country: United States