Trabeculectomy Versus Canaloplasty to Treat Glaucoma

Glaucoma Clinical Trial

Official title:

Comparison of Canaloplasty and Trabeculectomy in Patients With Open Angle Glaucoma and Inadequate Local Eye Pressure Lowering Therapy - a Prospective, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00854256
• Other study ID #: iScience-022-CG
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2009
• Last updated: April 12, 2013
• Start date: April 2009
• Est. completion date: May 2014

Study information

• Verified date: April 2013
• Source: University of Cologne
• Contact: Gerhard Welsandt, MD
• Phone: +49-221-478-0
• Email: g.welsandt[@]uni-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Canaloplasty
Canaloplasty surgery
• Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C surgery

Locations

Country	Name	City	State
Germany	Centre of Ophthalmology, University of Cologne	Cologne	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	iScience Interventional Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye pressure	Eye pressure is measured after 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months after surgery.	Within 12 month after surgery	No