A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.

Glaukos Corporation7 sites in 4 countries45 target enrollmentApril 2003

ConditionsOpen-Angle Glaucoma

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Open-Angle Glaucoma
Sponsor: Glaukos Corporation
Enrollment: 45
Locations: 7
Primary Endpoint: Efficacy
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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 refractory open-angle glaucoma subjects.

Detailed Description

Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

August 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Glaukos Corporation

Eligibility Criteria

Inclusion Criteria

•Diagnosed with primary open-angle glaucoma (POAG)
•Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
•Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)