Back to resultsA Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
Primary Purpose
Open-Angle Glaucoma
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Glaucoma Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open angle, Glaucoma, Refractory, Surgery
Eligibility Criteria
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
Sites / Locations
- University of Cologne
- Klinik für Augenheilkunde
- University Eye Clinic
- Instituto di Oftalmologia
- Ophthalmic Clinic
- Hospital Clínico San Carlos
- Instituo Oftalmologico de Aragon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00326040
Brief Title
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
Official Title
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Glaukos Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma
Keywords
Open angle, Glaucoma, Refractory, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Glaucoma Surgery
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of Clinical Affairs
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Cologne
City
Cologne
ZIP/Postal Code
50931
Country
Germany
Facility Name
Klinik für Augenheilkunde
City
Neubradenbrug
ZIP/Postal Code
17033
Country
Germany
Facility Name
University Eye Clinic
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Instituto di Oftalmologia
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ophthalmic Clinic
City
Rotterdam
Country
Netherlands
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Instituo Oftalmologico de Aragon
City
Zaragoza
ZIP/Postal Code
5007
Country
Spain
12. IPD Sharing Statement
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A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
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