A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2
Phase 4
- Conditions
- Open-Angle Glaucoma
- Interventions
- Device: Stent
- Registration Number
- NCT00326079
- Lead Sponsor
- Glaukos Corporation
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 61
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Stent - 2 Stent -
- Primary Outcome Measures
Name Time Method Efficacy 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Private Practice
🇩🇪Weinheim, Germany
Mainz University
🇩🇪Mainz, Germany
Klinik Vincentinum
🇩🇪Augsburg, Germany
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Beyoglu Eye Research and Education Hospital
🇹🇷Istanbul, Turkey
Vienna Medical University
🇦🇹Vienna, Austria
Instituto Oftalmológico de Aragón
🇪🇸Zaragoza, Spain