Trabeculectomy Versus Canaloplasty to Treat Glaucoma

This study is currently recruiting participants.

Verified April 2013 by University of Cologne

Sponsor:

Collaborator:

iScience Interventional Corporation

Information provided by:

University of Cologne

ClinicalTrials.gov Identifier:

NCT00854256

First received: March 2, 2009

Last updated: April 12, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2009

Last Updated Date

April 12, 2013

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Eye pressure [ Time Frame: Within 12 month after surgery ] [ Designated as safety issue: No ]

Eye pressure is measured after 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months after surgery.

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00854256 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trabeculectomy Versus Canaloplasty to Treat Glaucoma

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Canaloplasty
Intervention: Procedure: Canaloplasty
Active Comparator: Trabeculectomy with mitomycin C
Intervention: Procedure: Trabeculectomy with mitomycin C

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gerhard Welsandt, MD

+49-221-478-0

g.welsandt@uni-koeln.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00854256

Other Study ID Numbers ^ICMJE

iScience-022-CG

Has Data Monitoring Committee

Responsible Party

Gerhard Welsandt, MD, University of Cologne

Study Sponsor ^ICMJE

University of Cologne

Collaborators ^ICMJE

iScience Interventional Corporation

Investigators ^ICMJE

Not Provided

Information Provided By

University of Cologne

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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