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Trabeculectomy Versus Canaloplasty to Treat Glaucoma

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Canaloplasty
Trabeculectomy with mitomycin C
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre of Ophthalmology, University of CologneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Canaloplasty

Trabeculectomy with mitomycin C

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 2, 2009
Last Updated
April 12, 2013
Sponsor
University of Cologne
Collaborators
iScience Interventional Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00854256
Brief Title
Trabeculectomy Versus Canaloplasty to Treat Glaucoma
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cologne
Collaborators
iScience Interventional Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Canaloplasty
Arm Type
Experimental
Arm Title
Trabeculectomy with mitomycin C
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Canaloplasty
Intervention Description
Canaloplasty surgery
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy with mitomycin C
Intervention Description
Trabeculectomy with mitomycin C surgery
Primary Outcome Measure Information:
Title
Eye pressure
Description
Eye pressure is measured after 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months after surgery.
Time Frame
Within 12 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Welsandt, MD
Phone
+49-221-478-0
Email
g.welsandt@uni-koeln.de
Facility Information:
Facility Name
Centre of Ophthalmology, University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Trabeculectomy Versus Canaloplasty to Treat Glaucoma

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