A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
Phase 4
Completed
- Conditions
- Open-Angle Glaucoma
- Interventions
- Device: Glaucoma Surgery
- Registration Number
- NCT00326040
- 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 refractory open-angle glaucoma subjects.
- Detailed Description
Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Glaucoma Surgery -
- Primary Outcome Measures
Name Time Method Efficacy 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Ophthalmic Clinic
🇳🇱Rotterdam, Netherlands
University of Cologne
🇩🇪Cologne, Germany
Instituo Oftalmologico de Aragon
🇪🇸Zaragoza, Spain
Instituto di Oftalmologia
🇮🇹Parma, Italy
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
University Eye Clinic
🇮🇹Genova, Italy
Klinik für Augenheilkunde
🇩🇪Neubradenbrug, Germany