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

Glaukos Corporation65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma

Interventions

Model iS3 three-stent trabecular micro-bypass systemDEVICE

Provided in Arm/Group descriptions.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Glaucoma Associates of Tx

Dallas, Texas, United States

Outcomes

Primary Outcomes

Primary effectiveness endpoint

The change in mean diurnal IOP from baseline at 12 months

Time frame: Month 12 postoperative

Data from ClinicalTrials.gov

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