GATT Versus Canaloplasty (GVC)

Study Overview
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Brief Summary
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Study aims to compare the effectiveness and safety profile of Gonioscopy-assisted Transluminal Trabeculotomy 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. Gonioscopy-assisted Transluminal Trabeculotomy is the procedure that aims the same mechanism of aqueous outflow, however is perform with ab interno approach, which comprise it to the minimally invasive glaucoma surgery techniques. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication burden and complications rate. So far there is no comparison of the Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty available.

Official Title
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Longterm Comparison of Gonioscopy-assisted Transluminal Trabeculotomy and Canaloplasty in Open-angle Glaucoma Treatment

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Procedure: canaloplasty
* Procedure: Gonioscopy-assisted Transluminal Trabeculotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years and older (Adult, Older Adult) patients with confirmed uncontrolled open angle glaucoma no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed Exclusion Criteria: angle closure glaucoma congenital glaucoma inflammatory glaucoma

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Canaloplasty<br>Canaloplasty ab externo | Procedure: Gonioscopy-assisted Transluminal Trabeculotomy<br>* Gonioscopy-assisted Transluminal Trabeculotomy ab interno<br>|
| Active Comparator: Gonioscopy-assisted Transluminal Trabeculotomy<br>Gonioscopy-assisted Transluminal Trabeculotomy ab interno | Procedure: canaloplasty<br>* canaloplasty ab interno with tensioning 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 | 12 months | 
| 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP, medication, complications | intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively | 12 months | 
| IOP, medication, complications | intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonioscopy-assisted Transluminal Trabeculotomy, Canaloplasty, Glaucoma