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Trabeculectomy Versus Canaloplasty to Treat Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00854256
Recruitment Status : Unknown
Verified April 2013 by University of Cologne.
Recruitment status was:  Recruiting
First Posted : March 3, 2009
Last Update Posted : April 15, 2013
iScience Interventional Corporation
Information provided by:
University of Cologne

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : May 2014

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

Primary Outcome Measures :
  1. Eye pressure [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00854256

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Contact: Gerhard Welsandt, MD +49-221-478-0

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Centre of Ophthalmology, University of Cologne Recruiting
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
iScience Interventional Corporation

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Responsible Party: Gerhard Welsandt, MD, University of Cologne Identifier: NCT00854256     History of Changes
Other Study ID Numbers: iScience-022-CG
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Keywords provided by University of Cologne:

Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors