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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2009
CompletedFirst Posted
Study publicly available on registry
March 3, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 15, 2013
April 1, 2013
4.7 years
March 2, 2009
April 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eye pressure
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
Study Arms (2)
Canaloplasty
EXPERIMENTALTrabeculectomy with mitomycin C
ACTIVE COMPARATORInterventions
Trabeculectomy with mitomycin C surgery
Eligibility Criteria
You may qualify if:
- patients with open angle glaucoma and excavation of 0.4 - 0.8
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colognelead
- iScience Interventional Corporationcollaborator
Study Sites (1)
Centre of Ophthalmology, University of Cologne
Cologne, North Rhine-Westphalia, 50924, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 2, 2009
First Posted
March 3, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2013
Study Completion
May 1, 2014
Last Updated
April 15, 2013
Record last verified: 2013-04