GATT Versus Canaloplasty (GVC)

• Sponsor: Medical University of Bialystok (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05366647
• Collaborator: Medical University of Lublin (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle	Procedure: canaloplasty; Procedure: Gonioscopy-assisted Transluminal Trabeculotomy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Longterm Comparison of Gonioscopy-assisted Transluminal Trabeculotomy and Canaloplasty in Open-angle Glaucoma Treatment
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. success rate (complete and qualified success) [12 months]

   Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg

2. success rate (complete and qualified success) [24 months]

   Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg

Secondary Outcome Measures

1. IOP, medication, complications [12 months]

   intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively

2. IOP, medication, complications [24 months]

   intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology Clinic Medical University of Bialystok	Białystok		Poland	15-089

Sponsors and Collaborators

• Medical University of Bialystok
• Medical University of Lublin

Investigators

• Principal Investigator: Joanna Konopińska, Medical University of Bialystok, Poland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joanna Konopińska, M.D. PhD, Medical University of Bialystok
• ClinicalTrials.gov Identifier: NCT05366647
• Other Study ID Numbers: 1777
• First Posted: May 9, 2022
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joanna Konopińska, M.D. PhD, Medical University of Bialystok: Gonioscopy-assisted Transluminal Trabeculotomy; Canaloplasty; Glaucoma
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of May 9, 2022