A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

This study is ongoing, but not recruiting participants.

Sponsored by:	Glaukos Corporation
Information provided by:	Glaukos Corporation
ClinicalTrials.gov Identifier:	NCT00326014

Purpose

To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract 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 Combination With Cataract Surgery in 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:	58
Study Start Date:	April 2003
Estimated Study Completion Date:	December 2007

Arms	Assigned Interventions
A: Experimental	Device: iStent Glaucoma Surgery

Detailed Description:

Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

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 at least one glaucoma medication
Patient requiring cataract surgery and an intraocular lens implantation

Exclusion Criteria:

Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
Angle closure glaucoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326014

Locations

Germany
Klinik Vincentinum
Augsburg, Germany, 86150
Klinikum Neubrandenburg
Neubrandenburg, Germany, 17033
Rotkreuz Krankenhaus
München, Germany, 80637
Augenaerztliche Gemeinschaftspraxis
Weinheim, Germany, D69469
Universitats Augenklinik
Freiburg, Germany, 79106
Spain
Clinico San Carlos
Madrid, Spain, 28040
Instituto Oftalmológico de Aragón
Zaragoza, Spain, 50007
Switzerland
Augenklinik Kantonsspital
Winterthur, Switzerland, CH-8401

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-002
Study First Received:	May 12, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00326014
Health Authority:	Germany: Ethics Commission

Keywords provided by Glaukos Corporation:

Open angle
Glaucoma
Cataract
Surgery

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Cataract
Glaucoma, Open-Angle

Lens Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 14, 2009