Glaucoma
Conditions
Keywords
glaucoma
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 therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is necessary. The risks in the postoperative course in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C. Conversely, large glaucoma centers questioning the effectiveness of permanent pressure lowering of canaloplasty. Precisely this question is investigated in the study.
Interventions
PROCEDURETrabeculectomy with mitomycin C
Trabeculectomy with mitomycin C surgery
PROCEDURECanaloplasty
Canaloplasty surgery
Sponsors
iScience Interventional Corporation
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eye pressure | Within 12 month after surgery | Eye pressure is measured after 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months after surgery. |
Countries
Germany
Contacts
Primary ContactGerhard Welsandt, MD
Outcome results
None listed