Status:
COMPLETED
A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Lead Sponsor:
Glaukos Corporation
Conditions:
Open-Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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)
Eligibility Criteria
Inclusion
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on at least one glaucoma medication
- Patient requiring cataract surgery and an intraocular lens implantation
Exclusion
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00326014
Start Date
April 1 2003
End Date
December 1 2009
Last Update
June 8 2015
Active Locations (8)
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1
Klinik Vincentinum
Augsburg, Germany, 86150
2
Universitats Augenklinik
Freiburg im Breisgau, Germany, 79106
3
Rotkreuz Krankenhaus
München, Germany, 80637
4
Klinikum Neubrandenburg
Neubrandenburg, Germany, 17033