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

This study has been completed.
Information provided by:
Glaukos Corporation Identifier:
First received: May 12, 2006
Last updated: July 23, 2008
Last verified: July 2008
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.

Resource links provided by NLM:

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 24 months ]

Enrollment: 45
Study Start Date: April 2003
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: A Device: Glaucoma Surgery

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00326040

University of Cologne
Cologne, Germany, 50931
Klinik für Augenheilkunde
Neubradenbrug, Germany, 17033
University Eye Clinic
Genova, Italy, 16132
Instituto di Oftalmologia
Parma, Italy, 43100
Ophthalmic Clinic
Rotterdam, Netherlands
Hospital Clínico San Carlos
Madrid, Spain, 28040
Instituo Oftalmologico de Aragon
Zaragoza, Spain, 5007
Sponsors and Collaborators
Glaukos Corporation
Study Director: Head of Clinical Affairs Glaukos Corporation
  More Information

Responsible Party: Head of Clinical Affairs, Glaukos Corporation Identifier: NCT00326040     History of Changes
Other Study ID Numbers: GC-001A
Study First Received: May 12, 2006
Last Updated: July 23, 2008

Keywords provided by Glaukos Corporation:
Open angle

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases processed this record on April 28, 2017