Overview

This trial is active, not recruiting.

Condition open-angle glaucoma
Treatment istent and istent supra
Sponsor Glaukos Corporation
Start date September 2011
End date January 2017
Trial size 80 participants
Trial identifier NCT01456390, GCF-023

Summary

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Implantation of two iStent devices and one iStent supra device
istent and istent supra
Implantation of two iStent devices and one iStent supra device

Primary Outcomes

Measure
Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
time frame: 12 Months

Secondary Outcomes

Measure
Mean diurnal IOP < 18mm Hg
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs) - Open-angle glaucoma (including pseudoexfoliative) Exclusion Criteria: - Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs) - Prior ALT - Prior SLT within 90 days of screening visit

Additional Information

Official title A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents and a Postoperative Prostaglandin
Principal investigator Lilit A Voskanyan, MD, PhD
Description Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Glaukos Corporation.