Overview

This trial is active, not recruiting.

Condition subject with primary open-angle glaucoma (poag)
Treatment istent supra stent
Phase phase 4
Sponsor Glaukos Corporation
Start date December 2010
End date June 2017
Trial size 80 participants
Trial identifier NCT01252914, GCF-019

Summary

The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma
istent supra stent
Implantation of one iStent Supra Stent through a small temporal clear corneal incision

Primary Outcomes

Measure
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
time frame: 12 months

Secondary Outcomes

Measure
Mean diurnal Intraocular Pressure < 18 mmHg at month 12
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with primary open-angle glaucoma (POAG) - Subjects on two topical hypotensive medications Exclusion Criteria: - Traumatic, uveitic, neovascular, or angle closure glaucoma - Fellow eye already enrolled

Additional Information

Official title A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent
Principal investigator Lilit Voskanyan, MD
Description The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Glaukos Corporation.