NCT00326066
Completed
Not Applicable
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
ConditionsOpen-Angle Glaucoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Open-Angle Glaucoma
- Sponsor
- Glaukos Corporation
- Enrollment
- 47
- Locations
- 9
- Primary Endpoint
- Efficacy
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Efficacy
Time Frame: 24 months
Study Sites (9)
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