Status:
COMPLETED
A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
Lead Sponsor:
Glaukos Corporation
Conditions:
Open-Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 - Latanopro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00326066
Start Date
February 1 2005
End Date
May 1 2013
Last Update
March 9 2018
Active Locations (9)
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1
Vienna Medical Hospital
Vienna, Austria, A-1090
2
Mainz University
Mainz, Germany
3
Augenklinik der Technischen Universitat
Munich, Germany, 81675
4
Universitats- Augenklinik
Würzburg, Germany, D-97080