GATT Versus Canaloplasty (GVC)

Not Applicable

Recruiting

• Conditions: Glaucoma, Open-Angle
• Interventions: Procedure: canaloplasty; Procedure: Gonioscopy-assisted Transluminal Trabeculotomy

• Registration Number: NCT05366647
• Lead Sponsor: Medical University of Bialystok

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gonioscopy-assisted Transluminal Trabeculotomy	canaloplasty	Gonioscopy-assisted Transluminal Trabeculotomy ab interno
Canaloplasty	Gonioscopy-assisted Transluminal Trabeculotomy	Canaloplasty ab externo

Primary Outcome Measures

Name	Time	Method
success rate (complete and qualified success)	24 months	Success is defined: 1. IOP \< 21 mmHg and at least 20% IOP change from baseline 2. IOP \< 18 mmHg

Secondary Outcome Measures

Name	Time	Method
IOP, medication, complications	24 months	intraocular pressure change, medication postoperatively, complications intra- and postoperatively

Trial Locations

Locations (1)

Ophthalmology Clinic Medical University of Bialystok; 🇵🇱 Białystok, Poland