Status:
COMPLETED
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
Lead Sponsor:
Glaukos Corporation
Conditions:
Open-Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 refractory open-angle glaucoma subjects.
Detailed Description
Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.
Eligibility Criteria
Inclusion
- 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
- Angle closure glaucoma
- Fellow eye already enrolled
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00326040
Start Date
April 1 2003
End Date
August 1 2007
Last Update
July 25 2008
Active Locations (7)
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1
University of Cologne
Cologne, Germany, 50931
2
Klinik für Augenheilkunde
Neubradenbrug, Germany, 17033
3
University Eye Clinic
Genova, Italy, 16132
4
Instituto di Oftalmologia
Parma, Italy, 43100