Status:
UNKNOWN
A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2
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 subjects with open-angle glaucoma.
Detailed Description
The study compares 1 stent versus 2 stents.
Eligibility Criteria
Inclusion
- Diagnosed with open-angle glaucoma (OAG)
- Subject on at least one glaucoma medication
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00326079
Start Date
August 1 2004
End Date
May 1 2013
Last Update
March 29 2013
Active Locations (7)
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1
Vienna Medical University
Vienna, Austria, A-1090
2
Klinik Vincentinum
Augsburg, Germany, 86150
3
Mainz University
Mainz, Germany
4
Private Practice
Weinheim, Germany, D-69469