Trabeculectomy Versus Canaloplasty to Treat Glaucoma

University of Cologne

Status: Unknown

Conditions: Glaucoma

Treatments: Procedure: Canaloplasty; Procedure: Trabeculectomy with mitomycin C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00854256

iScience-022-CG

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Canaloplasty

Experimental group

Treatment:

Procedure: Canaloplasty

Trabeculectomy with mitomycin C

Active Comparator group

Treatment:

Procedure: Trabeculectomy with mitomycin C