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

This study has been completed.
Sponsor:
Information provided by:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00326040
First received: May 12, 2006
Last updated: July 23, 2008
Last verified: July 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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.

  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
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 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
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
  More Information

No publications provided

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

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Refractory
Surgery

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

ClinicalTrials.gov processed this record on August 28, 2014