A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Phase 4
Completed
- Conditions
- Open-Angle Glaucoma
- Interventions
- Device: iStent
- Registration Number
- NCT00326014
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.
- Detailed Description
Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on at least one glaucoma medication
- Patient requiring cataract surgery and an intraocular lens implantation
Exclusion Criteria
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A iStent -
- Primary Outcome Measures
Name Time Method Efficacy 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Universitats Augenklinik
🇩🇪Freiburg, Germany
Clinico San Carlos
🇪🇸Madrid, Spain
Rotkreuz Krankenhaus
🇩🇪München, Germany
Klinikum Neubrandenburg
🇩🇪Neubrandenburg, Germany
Klinik Vincentinum
🇩🇪Augsburg, Germany
Augenaerztliche Gemeinschaftspraxis
🇩🇪Weinheim, Germany
Instituto Oftalmológico de Aragón
🇪🇸Zaragoza, Spain
Augenklinik Kantonsspital
🇨🇭Winterthur, Switzerland