A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

This study has been completed.
Sponsor:
Information provided by:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00326014
First received: May 12, 2006
Last updated: July 2, 2010
Last verified: July 2010
  Purpose

To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.


Condition Intervention Phase
Open-Angle Glaucoma
Device: iStent
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 Combination With Cataract Surgery in 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: 58
Study Start Date: April 2003
Study Completion Date: December 2009
Arms Assigned Interventions
Experimental: A Device: iStent
Glaucoma Surgery
Other Name: Glaukos iStent

Detailed Description:

Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

  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 at least one glaucoma medication
  • Patient requiring cataract surgery and an intraocular lens implantation

Exclusion Criteria:

  • Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
  • Angle closure glaucoma
  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: NCT00326014

Locations
Germany
Klinik Vincentinum
Augsburg, Germany, 86150
Universitats Augenklinik
Freiburg, Germany, 79106
Rotkreuz Krankenhaus
München, Germany, 80637
Klinikum Neubrandenburg
Neubrandenburg, Germany, 17033
Augenaerztliche Gemeinschaftspraxis
Weinheim, Germany, D69469
Spain
Clinico San Carlos
Madrid, Spain, 28040
Instituto Oftalmológico de Aragón
Zaragoza, Spain, 50007
Switzerland
Augenklinik Kantonsspital
Winterthur, Switzerland, CH-8401
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: NCT00326014     History of Changes
Other Study ID Numbers: GC-002
Study First Received: May 12, 2006
Last Updated: July 2, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Cataract
Surgery

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

ClinicalTrials.gov processed this record on July 10, 2014