A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

Glaukos Corporation1 site in 1 country65 target enrollmentJuly 10, 2018

ConditionsGlaucoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Glaucoma
Sponsor: Glaukos Corporation
Enrollment: 65
Locations: 1
Primary Endpoint: Primary effectiveness endpoint
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.

Detailed Description

This is a prospective, multi-center, single arm, open-label clinical trial of the iS3 system. Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively.

Registry

clinicaltrials.gov

Start Date

July 10, 2018

End Date

September 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Glaukos Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of refractory open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior conventional incisional intraocular glaucoma surgeries.
•Phakic or pseudophakic.
•Males or females, 45 years of age or older.

Exclusion Criteria

•Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with vascular disorders.
•Active corneal inflammation or edema.
•Retinal disorders not associated with glaucoma.