NCT00326066

A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (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 newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.

Detailed description

The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.

Conditions

• Open-Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Glaucoma Surgery	Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.
PROCEDURE	cataract surgery only	Subjects will undergo routine cataract surgery only (no stent implant).

Timeline

• Start date: 2005-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2006-05-16
• Last updated: 2018-03-09

Locations

9 sites across 5 countries: Austria, Germany, Netherlands, Spain, Turkey (Türkiye)