A Study of the Glaukos Trabecular Micro-Bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2

This study is ongoing, but not recruiting participants.

First Received: May 12, 2006 Last Updated: February 5, 2009 History of Changes

Sponsored by:	Glaukos Corporation
Information provided by:	Glaukos Corporation
ClinicalTrials.gov Identifier:	NCT00326079

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 subjects with open-angle glaucoma.

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of the Glaukos Trabecular Micro-Bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2 Stents

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:

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

Enrollment:	61
Study Start Date:	August 2004
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Active Comparator	Device: Stent implantation of 1 Glaukos iStent versus 2 Glaukos iStents
2: Active Comparator	Device: Stent implantation of 1 Glaukos iStent versus 2 Glaukos iStents

Detailed Description:

The study compares 1 stent versus 2 stents.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosed with open-angle glaucoma (OAG)
Subject on at least one glaucoma medication
Signed informed consent

Exclusion Criteria:

Angle closure glaucoma
Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
Fellow eye already enrolled

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326079

Locations

Austria
Vienna Medical University
Vienna, Austria, A-1090
Germany
Klinik Vincentinum
Augsburg, Germany, 86150
Mainz University
Mainz, Germany
Private Practice
Weinheim, Germany, D-69469
Spain
Instituto Oftalmológico de Aragón
Zaragoza, Spain, 50007
Hospital Clínico San Carlos
Madrid, Spain, 28040
Turkey
Beyoglu Eye Research and Education Hospital
Istanbul, Turkey

Sponsors and Collaborators

Glaukos Corporation

Investigators

Study Director:

Head of Clinical Affairs

Glaukos Corporation

More Information

No publications provided

Responsible Party:	Glaukos Corporation ( Head of Clinical Affairs )
Study ID Numbers:	GCF-005
Study First Received:	May 12, 2006
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00326079 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Glaukos Corporation:

Open angle
Glaucoma
Surgery

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Ocular Hypertension

ClinicalTrials.gov processed this record on May 07, 2009