Trabeculectomy Versus Canaloplasty

Study Overview
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Brief Summary
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Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.

Official Title
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Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma

Conditions
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Glaucoma, Canaloplasty, Trabeculectomy

Intervention / Treatment
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* Procedure: trabeculectomy
* Procedure: Canaloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:1. diagnosed primary or secondary open-angle glaucoma 2. IOP > 16 mmHg (<60 days prior surgery) 3. IOP > 21 mmHg 4. no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed Exclusion Criteria: angle closure glaucoma congenital glaucoma combined procedures (glaucoma and cataract)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trabeculectomy<br>Trabeculectomy with Mitomycin C | Procedure: trabeculectomy<br>* trabeculectomy with mitomycin C 0.2mg/ml<br>|
| Active Comparator: Canaloplasty<br>Canaloplasty with implant of suture | Procedure: Canaloplasty<br>* Canaloplasty with implant of suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate (complete and qualified success) | Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg | 1 year | 
| success rate (complete and qualified success) | Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP, medication, complications | intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively | 1 year | 
| IOP, medication, complications | intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trabeculectomy,, canaloplasty,, glaucoma surgery, non-penetrating surgery