NCT00323284

A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Detailed description

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.

Conditions

• Open-Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	iStent plus Cataract Surgery	ab interno trabecular bypass stent surgery
PROCEDURE	Cataract surgery only	Cataract surgery only

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-07-01
• Completion: 2010-03-01
• First posted: 2006-05-09
• Last updated: 2018-01-12
• Results posted: 2012-10-04

Locations

31 sites across 1 country: United States