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

Glaukos Corporation45 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open-Angle Glaucoma

Interventions

Glaucoma SurgeryDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

University of Cologne

Cologne, Germany

Klinik für Augenheilkunde

Neubradenbrug, Germany

University Eye Clinic

Genova, Italy

Instituto di Oftalmologia

Parma, Italy

Outcomes

Primary Outcomes

Efficacy

Time frame: 24 months

Data from ClinicalTrials.gov

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