GATT Versus Canaloplasty (GVC)

NCT ID: NCT05366647

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-06-01

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.

Detailed Description

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Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canaloplasty

Canaloplasty ab externo

Group Type ACTIVE_COMPARATOR

Gonioscopy-assisted Transluminal Trabeculotomy

Intervention Type PROCEDURE

Gonioscopy-assisted Transluminal Trabeculotomy ab interno

Gonioscopy-assisted Transluminal Trabeculotomy

Gonioscopy-assisted Transluminal Trabeculotomy ab interno

Group Type ACTIVE_COMPARATOR

canaloplasty

Intervention Type PROCEDURE

canaloplasty ab interno with tensioning suture

Interventions

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canaloplasty

canaloplasty ab interno with tensioning suture

Intervention Type PROCEDURE

Gonioscopy-assisted Transluminal Trabeculotomy

Gonioscopy-assisted Transluminal Trabeculotomy ab interno

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role collaborator

Medical University of Bialystok

OTHER

Sponsor Role lead

Responsible Party

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Joanna Konopińska

Head of Ophthalomogy, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanna Konopińska

Role: PRINCIPAL_INVESTIGATOR

Medical University of Bialystok, Poland

Locations

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Ophthalmology Clinic Medical University of Bialystok

Bialystok, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Joanna Konopińska

Role: CONTACT

+48600471666

Ewa Kosior-Jarecka

Role: CONTACT

Facility Contacts

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Joanna Konopińska, PhD

Role: primary

600471666 ext. +48

Other Identifiers

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1777

Identifier Type: -

Identifier Source: org_study_id

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