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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Glaukos Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00326079
First Posted: May 16, 2006
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Glaukos Corporation
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2 Stents

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

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

Enrollment: 61
Study Start Date: August 2004
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: Stent
implantation of 1 Glaukos iStent versus 2 Glaukos iStents
Other Name: iStent
Active Comparator: 2 Device: Stent
implantation of 1 Glaukos iStent versus 2 Glaukos iStents
Other Name: iStent

Detailed Description:
The study compares 1 stent versus 2 stents.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
Hospital Clínico San Carlos
Madrid, Spain, 28040
Instituto Oftalmológico de Aragón
Zaragoza, Spain, 50007
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

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00326079     History of Changes
Other Study ID Numbers: GCF-005
First Submitted: May 12, 2006
First Posted: May 16, 2006
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Surgery

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