Overview

This trial is active, not recruiting.

Condition open-angle glaucoma
Treatments one istent, two istent
Phase phase 4
Sponsor Glaukos Corporation
Start date September 2011
End date January 2017
Trial size 80 participants
Trial identifier NCT01455467, GCF-024

Summary

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

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)
Implantation of one iStent in conjunction with cataract surgery
one istent
Implantation of one iStent in conjunction with cataract surgery
(Active Comparator)
Implantation of two iStent devices in conjunction with cataract surgery
two istent
Implantation of two iStent in conjunction with cataract surgery

Primary Outcomes

Measure
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation - Primary open-angle glaucoma (including pigmentary or pseudoexfoliative) Exclusion Criteria: - Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye) - Prior stent implantations (study eye)

Additional Information

Official title A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
Principal investigator Lilit A Voskanyan, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Glaukos Corporation.