- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00854256
Trabeculectomy Versus Canaloplasty to Treat Glaucoma
April 12, 2013 updated by: University of Cologne
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gerhard Welsandt, MD
- Phone Number: +49-221-478-0
- Email: g.welsandt@uni-koeln.de
Study Locations
-
-
NRW
-
Cologne, NRW, Germany, 50924
- Recruiting
- Centre of Ophthalmology, University of Cologne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Canaloplasty
|
Canaloplasty surgery
|
Active Comparator: Trabeculectomy with mitomycin C
|
Trabeculectomy with mitomycin C surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within 12 month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
March 2, 2009
First Submitted That Met QC Criteria
March 2, 2009
First Posted (Estimate)
March 3, 2009
Study Record Updates
Last Update Posted (Estimate)
April 15, 2013
Last Update Submitted That Met QC Criteria
April 12, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- iScience-022-CG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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