Trabeculectomy Versus Canaloplasty to Treat Glaucoma

This study is not yet open for participant recruitment.

Verified by University of Cologne, April 2009

First Received: March 2, 2009 Last Updated: April 2, 2009 History of Changes

Sponsors and Collaborators:	University of Cologne iScience Interventional Corporation
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00854256

Purpose

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	Intervention
Glaucoma	Procedure: Canaloplasty Procedure: Trabeculectomy with mitomycin C

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Comparison of Canaloplasty and Trabeculectomy in Patients With Open Angle Glaucoma and Inadequate Local Eye Pressure Lowering Therapy - a Prospective, Randomized Study

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma Surgery

Drug Information available for: Mitomycin Mitomycins

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:

eye pressure [ Time Frame: 1 day, 1 week, 1 month, 3 month, 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Canaloplasty: Experimental	Procedure: Canaloplasty Canaloplasty surgery
Trabeculectomy with mitomycin C: Active Comparator	Procedure: Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C surgery

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854256

Contacts

Contact: Gerhard Welsandt, MD

+49-221-478-0

g.welsandt@uni-koeln.de

Locations

Germany, NRW
Centre of Ophthalmology, University of Cologne
Cologne, NRW, Germany, 50924

Sponsors and Collaborators

University of Cologne

iScience Interventional Corporation

More Information

No publications provided

Responsible Party:	University of Cologne ( Gerhard Welsandt, MD )
Study ID Numbers:	iScience-022-CG
Study First Received:	March 2, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00854256 History of Changes
Health Authority:	Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

glaucoma

Study placed in the following topic categories:

Anti-Bacterial Agents
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Mitomycin

Alkylating Agents
Mitomycins
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Eye Diseases
Enzyme Inhibitors
Antibiotics, Antineoplastic
Mitomycins
Pharmacologic Actions

Glaucoma
Therapeutic Uses
Mitomycin
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Ocular Hypertension

ClinicalTrials.gov processed this record on September 11, 2009