Trabeculectomy Versus Canaloplasty to Treat Glaucoma

Sponsor

University of Cologne (Other)

Overall Status

Unknown status

CT.gov ID

NCT00854256

Collaborator

iScience Interventional Corporation (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Procedure: Canaloplasty Procedure: Trabeculectomy with mitomycin C	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Canaloplasty	Procedure: Canaloplasty Canaloplasty surgery
Active Comparator: Trabeculectomy with mitomycin C	Procedure: Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C surgery

Arm

Intervention/Treatment

Experimental: Canaloplasty

Procedure: Canaloplasty

Canaloplasty surgery

Active Comparator: Trabeculectomy with mitomycin C

Procedure: Trabeculectomy with mitomycin C

Trabeculectomy with mitomycin C surgery

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Ophthalmology, University of Cologne	Cologne	NRW	Germany	50924

Sponsors and Collaborators

University of Cologne
iScience Interventional Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00854256

Other Study ID Numbers:

iScience-022-CG

First Posted:

Mar 3, 2009

Last Update Posted:

Apr 15, 2013

Last Verified:

Apr 1, 2013

Keywords provided by , ,

glaucoma

Additional relevant MeSH terms:

Glaucoma

Mitomycins

Mitomycin

Study Results

No Results Posted as of Apr 15, 2013