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

NCT01517477

GCF-033

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

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

Experimental group

Description:

Device: One iStent

Treatment:

Device: iStent

Device: iStent

Device: iStent

Second Arm: Two iStents

Experimental group

Description:

Device: Two iStent devices

Treatment:

Device: iStent

Device: iStent

Device: iStent

Third Arm: Three iStents

Experimental group

Description:

Device: Three iStent devices

Treatment:

Device: iStent

Device: iStent

Device: iStent