GATT Versus Canaloplasty (GVC)

Medical University of Bialystok

Status: Enrolling

Conditions: Glaucoma, Open-Angle

Treatments: Procedure: Gonioscopy-assisted Transluminal Trabeculotomy; Procedure: canaloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05366647

1777

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Canaloplasty

Active Comparator group

Description:

Canaloplasty ab externo

Treatment:

Procedure: Gonioscopy-assisted Transluminal Trabeculotomy

Gonioscopy-assisted Transluminal Trabeculotomy

Active Comparator group

Description:

Gonioscopy-assisted Transluminal Trabeculotomy ab interno

Treatment:

Procedure: canaloplasty