Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

Glaukos

Status: Completed

Conditions: Primary Open Angle Glaucoma (POAG)

Treatments: Device: iStent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01252849

GCF-016

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosed with primary open-angle glaucoma (POAG)
• Subject on two topical hypotensive medications

Exclusion criteria

• Traumatic, uveitic, neovascular, or angle closure glaucoma
• Fellow eye already enrolled

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 3 patient groups

First Arm: One iStent, medication

Experimental group

Description:

Device: One iStent, medication

Treatment:

Device: iStent

Device: iStent

Device: iStent

Second Arm: Two iStents, medication

Experimental group

Description:

Device: Two iStent devices, medication

Treatment:

Device: iStent

Device: iStent

Device: iStent

Third Arm: Three iStents, medication

Experimental group

Description:

Device: Three iStent devices, medication

Treatment:

Device: iStent

Device: iStent

Device: iStent