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A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects

This study has been completed.
Sponsor:
Information provided by:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00326040
First received: May 12, 2006
Last updated: July 23, 2008
Last verified: July 2008

May 12, 2006
July 23, 2008
April 2003
Not Provided
Efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Efficacy
  • The primary effectiveness measure will be intraocular pressure evaluation from preoperative baseline
  • Safety
  • Incidence of adverse events that occur during the surgical procedure and postoperative period.
Complete list of historical versions of study NCT00326040 on ClinicalTrials.gov Archive Site
Not Provided
Evaluation of Glaucoma medications preoperatively vs postoperatively.
Not Provided
Not Provided
 
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.

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 refractory open-angle glaucoma subjects.

Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Open-Angle Glaucoma
Device: Glaucoma Surgery
Experimental: A
Intervention: Device: Glaucoma Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
August 2007
Not Provided

Inclusion Criteria:

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
  • Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)

Exclusion Criteria:

  • Angle closure glaucoma
  • Fellow eye already enrolled
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Netherlands,   Spain
 
NCT00326040
GC-001A
Yes
Head of Clinical Affairs, Glaukos Corporation
Glaukos Corporation
Not Provided
Study Director: Head of Clinical Affairs Glaukos Corporation
Glaukos Corporation
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP