GATT Versus Canaloplasty (GVC)

NCT05366647 | Recruiting

• 1 other identifier: 1777
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Open-Angle

Keywords

Gonioscopy-assisted Transluminal Trabeculotomy; Canaloplasty; Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• IOP, medication, complications

  12 months

• IOP, medication, complications

  24 months

Study Arms (2)

Canaloplasty

ACTIVE COMPARATOR

Canaloplasty ab externo

Procedure: Gonioscopy-assisted Transluminal Trabeculotomy

Gonioscopy-assisted Transluminal Trabeculotomy

ACTIVE COMPARATOR

Gonioscopy-assisted Transluminal Trabeculotomy ab interno

Procedure: canaloplasty

Interventions

canaloplasty PROCEDURE

canaloplasty ab interno with tensioning suture

Gonioscopy-assisted Transluminal Trabeculotomy

Gonioscopy-assisted Transluminal Trabeculotomy PROCEDURE

Gonioscopy-assisted Transluminal Trabeculotomy ab interno

Canaloplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years and older (Adult, Older Adult)
• patients with confirmed uncontrolled open angle glaucoma
• no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed

You may not qualify if:

• angle closure glaucoma
• congenital glaucoma
• inflammatory glaucoma

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Medical University of Lublin: collaborator

Study Sites (1)

Ophthalmology Clinic Medical University of Bialystok

Bialystok, 15-089, Poland

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Joanna Konopińska

  Medical University of Bialystok, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna Konopińska

CONTACT

+48600471666; joannakonopinska@o2.pl

Ewa Kosior-Jarecka

CONTACT

ekosior@poczta.onet.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalomogy, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years

Locations

PL (1)