Status:
UNKNOWN
Trabeculectomy Versus Canaloplasty to Treat Glaucoma
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
iScience Interventional Corporation
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering the...
Eligibility Criteria
Inclusion
- patients with open angle glaucoma and excavation of 0.4 - 0.8
- 60 eyes of 60 patients (30 patients for trabeculectomy, 30 patients for Canaloplasty) The ratio of female / male is not involved.
- Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
- Local drug therapy: at least 2 eye pressure lowering ingredients or absolute intolerance to preservatives or eye drops.
- general anesthesia possible.
- The operation must be signed by the surgeon as a state-of-the-art performed without complication to be evaluated. If the operation does not meet this criterion, the patient is excluded from the study.
Exclusion
- all patients are not included in the group of inclusion criteria, or:
- Phenprocoumon therapy.
- operation is not done state-of-the-art.
- after the surgery: additional eye pressure lowering surgery, cataract surgery, keratoplasty, laser surgery in the anterior eye segment (except suture lysis after trabeculectomy)
- Uveitis, or possible inflammation of the eye
- Previous eye pressure lowering operations or laser interventions
- Corneal Refractive Surgery (pseudophakia allowed)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00854256
Start Date
April 1 2009
End Date
May 1 2014
Last Update
April 15 2013
Active Locations (1)
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1
Centre of Ophthalmology, University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50924