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NCT05366647 Clinical Trial

GATT Versus Canaloplasty (GVC)

Glaucoma, Open-Angle Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05366647
Other study ID # 1777
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date June 1, 2025

Study information
Verified date May 2022
Source Medical University of Bialystok
Contact Joanna Konopinska
Phone +48600471666
Email joannakonopinska@o2.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• canaloplasty
canaloplasty ab interno with tensioning suture
• Gonioscopy-assisted Transluminal Trabeculotomy
Gonioscopy-assisted Transluminal Trabeculotomy ab interno

Locations
Country Name City State
Poland Ophthalmology Clinic Medical University of Bialystok Bialystok

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Bialystok Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary success rate (complete and qualified success) Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg 12 months
Primary success rate (complete and qualified success) Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg 24 months
Secondary IOP, medication, complications intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively 12 months
Secondary IOP, medication, complications intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively 24 months
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