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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00326079
First received: May 12, 2006
Last updated: March 28, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 Names:
  • Stent
  • iStent
Active Comparator: 2 Device: Stent
implantation of 1 Glaukos iStent versus 2 Glaukos iStents
Other Names:
  • Stent
  • iStent

Detailed Description:

The study compares 1 stent versus 2 stents.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00326079     History of Changes
Other Study ID Numbers: GCF-005
Study First Received: May 12, 2006
Last Updated: March 28, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Surgery

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

ClinicalTrials.gov processed this record on October 20, 2014