A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
- Conditions
- Open-Angle Glaucoma
- Registration Number
- NCT00326066
- 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 newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.
- Detailed Description
The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications.
- All subjects must need cataract surgery.
- 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
- Primary Outcome Measures
Name Time Method Efficacy 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Vienna Medical Hospital
🇦🇹Vienna, Austria
Mainz University
🇩🇪Mainz, Germany
Augenklinik der Technischen Universitat
🇩🇪Munich, Germany
Universitats- Augenklinik
🇩🇪Wurzburg, Germany
The Netherlands Ophthalmic Research Institute
🇳🇱Amsterdam, Netherlands
Ophthalmic Clinic
🇳🇱Rotterdam, Netherlands
Clinico San Carlos
🇪🇸Madrid, Spain
Instituto Oftalmológico de Aragón
🇪🇸Zaragoza, Spain
Beyoglu Eye Research and Education Hospital
🇹🇷Istanbul, Turkey
Vienna Medical Hospital🇦🇹Vienna, Austria