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

This study has been completed.

Sponsored by:	Glaukos Corporation
Information provided by:	Glaukos Corporation
ClinicalTrials.gov Identifier:	NCT00326040

Purpose

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.

Condition	Intervention	Phase
Open-Angle Glaucoma	Device: Glaucoma Surgery	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:

Efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	April 2003
Study Completion Date:	August 2007

Arms	Assigned Interventions
A: Experimental	Device: Glaucoma Surgery

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326040

Locations

Germany
University of Cologne
Cologne, Germany, 50931
Klinik für Augenheilkunde
Neubradenbrug, Germany, 17033
Italy
University Eye Clinic
Genova, Italy, 16132
Instituto di Oftalmologia
Parma, Italy, 43100
Netherlands
Ophthalmic Clinic
Rotterdam, Netherlands
Spain
Instituo Oftalmologico de Aragon
Zaragoza, Spain, 5007
Hospital Clínico San Carlos
Madrid, Spain, 28040

Sponsors and Collaborators

Glaukos Corporation

Investigators

Study Director:

Head of Clinical Affairs

Glaukos Corporation

More Information

Responsible Party:	Glaukos Corporation ( Head of Clinical Affairs )
Study ID Numbers:	GC-001A
Study First Received:	May 12, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00326040
Health Authority:	Italy: Ethics Committee

Keywords provided by Glaukos Corporation:

Open angle
Glaucoma
Refractory
Surgery

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 14, 2009