Overview

This trial is active, not recruiting.

Condition open-angle glaucoma
Treatment stent
Phase phase 4
Sponsor Glaukos Corporation
Start date August 2004
End date May 2013
Trial size 61 participants
Trial identifier NCT00326079, GCF-005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
stent Stent
implantation of 1 Glaukos iStent versus 2 Glaukos iStents
(Active Comparator)
stent Stent
implantation of 1 Glaukos iStent versus 2 Glaukos iStents

Primary Outcomes

Measure
Efficacy
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2 Stents
Description The study compares 1 stent versus 2 stents.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Glaukos Corporation.