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

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ClinicalTrials.gov Identifier: NCT00326079
Recruitment Status : Unknown
Verified March 2013 by Glaukos Corporation.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2006
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
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 subjects with open-angle glaucoma.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Device: Stent Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
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
Study Start Date : August 2004
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
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



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, 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

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

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00326079     History of Changes
Other Study ID Numbers: GCF-005
First Posted: May 16, 2006    Key Record Dates
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