Overview

This trial is active, not recruiting.

Condition primary open-angle glaucoma
Treatment istent
Phase phase 4
Sponsor Glaukos Corporation
Start date September 2013
End date August 2019
Trial size 500 participants
Trial identifier NCT01841437, GTS100-PAR

Summary

The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
istent

Primary Outcomes

Measure
Rate of sight-threatening adverse events
time frame: 36 months

Secondary Outcomes

Measure
Other ocular adverse events
time frame: 36 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Consecutive subjects in whom implantation of the iStent is attempted Exclusion Criteria: - Please refer to approved indications in Directions for Use

Additional Information

Official title Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Glaukos Corporation.