A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2 Stents

Glaukos Corporation7 sites in 4 countries61 target enrollmentAugust 2004

ConditionsOpen-Angle Glaucoma

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Open-Angle Glaucoma
Sponsor: Glaukos Corporation
Enrollment: 61
Locations: 7
Primary Endpoint: Efficacy
Last Updated: 13 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 subjects with open-angle glaucoma.

Detailed Description

The study compares 1 stent versus 2 stents.

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

May 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Glaukos Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosed with open-angle glaucoma (OAG)
•Subject on at least one glaucoma medication
•Signed informed consent

Exclusion Criteria

•Angle closure glaucoma
•Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
•Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
•Fellow eye already enrolled