A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects

Glaukos

Status and phase: Completed; Phase 4

Conditions: Open-Angle Glaucoma

Treatments: Device: Glaucoma Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326040

GC-001A

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma subjects.

Full description

Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with primary open-angle glaucoma (POAG)
• Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
• Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)

Exclusion criteria

• Angle closure glaucoma
• Fellow eye already enrolled

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

A

Experimental group

Treatment:

Device: Glaucoma Surgery