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

This study has been completed.
Information provided by (Responsible Party):
Glaukos Corporation Identifier:
First received: May 12, 2006
Last updated: June 3, 2015
Last verified: June 2015
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: 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 ]

Enrollment: 58
Study Start Date: April 2003
Study Completion Date: December 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00326014

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
Clinico San Carlos
Madrid, Spain, 28040
Instituto Oftalmológico de Aragón
Zaragoza, Spain, 50007
Augenklinik Kantonsspital
Winterthur, Switzerland, CH-8401
Sponsors and Collaborators
Glaukos Corporation
Study Director: Head of clinical Affairs Glaukos Corporation
  More Information

Responsible Party: Glaukos Corporation Identifier: NCT00326014     History of Changes
Other Study ID Numbers: GC-002
Study First Received: May 12, 2006
Last Updated: June 3, 2015

Keywords provided by Glaukos Corporation:
Open angle

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases processed this record on April 28, 2017