Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents

Glaukos

Status and phase: Completed; Phase 4

Conditions: Subjects With Primary Open-angle Glaucoma (POAG)

Treatments: Device: iStents

Study type: Interventional

Funder types: Industry

Identifiers

NCT01252888

GCF-018

Details and patient eligibility

About

The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.

Full description

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Two iStent devices and medication

Experimental group

Description:

Implantation of two iStents through small temporal clear corneal incision

Treatment:

Device: iStents