A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
This trial is active, not recruiting.
|Treatments||glaucoma surgery, cataract surgery only|
|Start date||February 2005|
|End date||May 2013|
|Trial size||47 participants|
|Trial identifier||NCT00326066, GCF-007|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Vienna, Austria||Vienna Medical Hospital||no longer recruiting|
|Mainz, Germany||Mainz University||no longer recruiting|
|Munich, Germany||Augenklinik der Technischen Universitat||no longer recruiting|
|Wurzburg, Germany||Universitats- Augenklinik||no longer recruiting|
|Amsterdam, Netherlands||The Netherlands Ophthalmic Research Institute||no longer recruiting|
|Rotterdam, Netherlands||Ophthalmic Clinic||no longer recruiting|
|Madrid, Spain||Clinico San Carlos||no longer recruiting|
|Zaragoza, Spain||Instituto Oftalmológico de Aragón||no longer recruiting|
|Istanbul, Turkey||Beyoglu Eye Research and Education Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: 24 months
Male or female participants at least 18 years old.
Inclusion Criteria: - 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. 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
|Official title||A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension|
|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.|
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