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Trabeculectomy Versus Canaloplasty to Treat Glaucoma

This study is currently recruiting participants. (see Contacts and Locations)
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
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canaloplasty Procedure: Canaloplasty
Canaloplasty surgery
Active Comparator: Trabeculectomy with mitomycin C 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Gerhard Welsandt, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT00854256     History of Changes
Other Study ID Numbers: iScience-022-CG
Study First Received: March 2, 2009
Last Updated: April 12, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
glaucoma

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014