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

NCT ID: NCT00326040

Last Updated: 2008-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Open-Angle Glaucoma

Keywords

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Open angle Glaucoma Refractory Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Glaucoma Surgery

Intervention Type DEVICE

Interventions

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Glaucoma Surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Glaukos Corporation

Principal Investigators

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Head of Clinical Affairs

Role: STUDY_DIRECTOR

Glaukos Corporation

Locations

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University of Cologne

Cologne, , Germany

Site Status

Klinik für Augenheilkunde

Neubradenbrug, , Germany

Site Status

University Eye Clinic

Genova, , Italy

Site Status

Instituto di Oftalmologia

Parma, , Italy

Site Status

Ophthalmic Clinic

Rotterdam, , Netherlands

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Instituo Oftalmologico de Aragon

Zaragoza, , Spain

Site Status

Countries

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Germany Italy Netherlands Spain

Other Identifiers

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GC-001A

Identifier Type: -

Identifier Source: org_study_id