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

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ClinicalTrials.gov Identifier: NCT00326040
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : July 25, 2008
Sponsor:
Information provided by:
Glaukos Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Open-Angle Glaucoma Device: Glaucoma Surgery Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.
Study Start Date : April 2003
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: A Device: Glaucoma Surgery



Primary Outcome Measures :
  1. Efficacy [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Hospital Clínico San Carlos
Madrid, Spain, 28040
Instituo Oftalmologico de Aragon
Zaragoza, Spain, 5007
Sponsors and Collaborators
Glaukos Corporation
Investigators
Study Director: Head of Clinical Affairs Glaukos Corporation

Responsible Party: Head of Clinical Affairs, Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00326040     History of Changes
Other Study ID Numbers: GC-001A
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: July 25, 2008
Last Verified: July 2008

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Refractory
Surgery

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases