GATT Versus Canaloplasty (GVC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Procedure: Gonioscopy-assisted Transluminal Trabeculotomy; Procedure: canaloplasty

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna Konopińska; Phone Number: +48600471666; Email: joannakonopinska@o2.pl
• Study Contact Backup: Name: Ewa Kosior-Jarecka; Email: ekosior@poczta.onet.pl

Study Locations

• Poland
  • Białystok, Poland, 15-089
    • Recruiting
    • Ophthalmology Clinic Medical University of Bialystok
    • Contact: Joanna Konopińska, PhD; Phone Number: +48 600471666; Email: joannakonopinska@o2.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Canaloplasty; Canaloplasty ab externo	Procedure: Gonioscopy-assisted Transluminal Trabeculotomy; Gonioscopy-assisted Transluminal Trabeculotomy ab interno
Active Comparator: Gonioscopy-assisted Transluminal Trabeculotomy; Gonioscopy-assisted Transluminal Trabeculotomy ab interno	Procedure: canaloplasty; canaloplasty ab interno with tensioning suture

What is the study measuring?

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 change 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 change from baseline 2. IOP < 18 mmHg	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Collaborators: Medical University of Lublin
• Investigators: Principal Investigator: Joanna Konopińska, Medical University of Bialystok, Poland

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Glaucoma; Canaloplasty; Gonioscopy-assisted Transluminal Trabeculotomy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 1777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All materials and information are available upon an e-mail request on principal investigator
• IPD Sharing Time Frame: 5 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No