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

March 2, 2009
April 12, 2013
April 2009
December 2013   (final data collection date for primary outcome measure)
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.
eye pressure [ Time Frame: 1 day, 1 week, 1 month, 3 month, 12 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00854256 on ClinicalTrials.gov Archive Site
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Trabeculectomy Versus Canaloplasty to Treat Glaucoma
Comparison of Canaloplasty and Trabeculectomy in Patients With Open Angle Glaucoma and Inadequate Local Eye Pressure Lowering Therapy - a Prospective, Randomized Study

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
  • Procedure: Canaloplasty
    Canaloplasty surgery
  • Procedure: Trabeculectomy with mitomycin C
    Trabeculectomy with mitomycin C surgery
  • Experimental: Canaloplasty
    Intervention: Procedure: Canaloplasty
  • Active Comparator: Trabeculectomy with mitomycin C
    Intervention: Procedure: Trabeculectomy with mitomycin C
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2014
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Gerhard Welsandt, MD +49-221-478-0 g.welsandt@uni-koeln.de
Germany
 
NCT00854256
iScience-022-CG
No
Gerhard Welsandt, MD, University of Cologne
University of Cologne
iScience Interventional Corporation
Not Provided
University of Cologne
April 2013

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