Back to resultsA Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2
Primary Purpose
Open-Angle Glaucoma
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Stent
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open angle, Glaucoma, Surgery
Eligibility Criteria
Inclusion Criteria: Diagnosed with open-angle glaucoma (OAG) Subject on at least one glaucoma medication Signed informed consent Exclusion Criteria: Angle closure glaucoma Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) Fellow eye already enrolled
Sites / Locations
- Vienna Medical University
- Klinik Vincentinum
- Mainz University
- Private Practice
- Hospital Clínico San Carlos
- Instituto Oftalmológico de Aragón
- Beyoglu Eye Research and Education Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00326079
Brief Title
A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2
Official Title
A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2 Stents
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 subjects with open-angle glaucoma.
Detailed Description
The study compares 1 stent versus 2 stents.
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, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Stent
Other Intervention Name(s)
iStent
Intervention Description
implantation of 1 Glaukos iStent versus 2 Glaukos iStents
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 open-angle glaucoma (OAG)
Subject on at least one glaucoma medication
Signed informed consent
Exclusion Criteria:
Angle closure glaucoma
Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
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
Vienna Medical University
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Klinik Vincentinum
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Mainz University
City
Mainz
Country
Germany
Facility Name
Private Practice
City
Weinheim
ZIP/Postal Code
D-69469
Country
Germany
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Instituto Oftalmológico de Aragón
City
Zaragoza
ZIP/Postal Code
50007
Country
Spain
Facility Name
Beyoglu Eye Research and Education Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2
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