Overview

This trial is active, not recruiting.

Condition open-angle glaucoma
Treatments istent, slt
Phase phase 4
Sponsor Glaukos Corporation
Start date September 2011
End date January 2017
Trial size 80 participants
Trial identifier NCT01444105, GCF-028

Summary

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

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 two iStent devices
istent
Implantation of two iStent devices
(Active Comparator)
Laser treatment
slt
Laser treatment

Primary Outcomes

Measure
Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
Principal investigator Lilit A Voskanyan, MD, PhD
Description Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Glaukos Corporation.