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

Glaukos

Status and phase: Completed; Phase 4

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

Treatments: Device: iStent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01252862

GCF-017

Details and patient eligibility

About

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects 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: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosed with primary open-angle glaucoma (POAG)
• Subject on one topical hypotensive medication

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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40 participants in 1 patient group

Two iStents devices

Experimental group

Description:

Two iStents devices will be implanted

Treatment:

Device: iStent