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GATT Versus Canaloplasty (GVC)

Primary Purpose

Glaucoma, Open-Angle

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
canaloplasty
Gonioscopy-assisted Transluminal Trabeculotomy
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Gonioscopy-assisted Transluminal Trabeculotomy, Canaloplasty, Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ophthalmology Clinic Medical University of Bialystok

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Canaloplasty

Gonioscopy-assisted Transluminal Trabeculotomy

Arm Description

Canaloplasty ab externo

Gonioscopy-assisted Transluminal Trabeculotomy ab interno

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2022
Last Updated
May 4, 2022
Sponsor
Medical University of Bialystok
Collaborators
Medical University of Lublin
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1. Study Identification

Unique Protocol Identification Number
NCT05366647
Brief Title
GATT Versus Canaloplasty (GVC)
Official Title
Longterm Comparison of Gonioscopy-assisted Transluminal Trabeculotomy and Canaloplasty in Open-angle Glaucoma Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Bialystok
Collaborators
Medical University of Lublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
Gonioscopy-assisted Transluminal Trabeculotomy, Canaloplasty, Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Canaloplasty
Arm Type
Active Comparator
Arm Description
Canaloplasty ab externo
Arm Title
Gonioscopy-assisted Transluminal Trabeculotomy
Arm Type
Active Comparator
Arm Description
Gonioscopy-assisted Transluminal Trabeculotomy ab interno
Intervention Type
Procedure
Intervention Name(s)
canaloplasty
Intervention Description
canaloplasty ab interno with tensioning suture
Intervention Type
Procedure
Intervention Name(s)
Gonioscopy-assisted Transluminal Trabeculotomy
Intervention Description
Gonioscopy-assisted Transluminal Trabeculotomy ab interno
Primary Outcome Measure Information:
Title
success rate (complete and qualified success)
Description
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
Time Frame
12 months
Title
success rate (complete and qualified success)
Description
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
Time Frame
24 months
Secondary Outcome Measure Information:
Title
IOP, medication, complications
Description
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
Time Frame
12 months
Title
IOP, medication, complications
Description
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Konopińska
Phone
+48600471666
Email
joannakonopinska@o2.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Ewa Kosior-Jarecka
Email
ekosior@poczta.onet.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Konopińska
Organizational Affiliation
Medical University of Bialystok, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology Clinic Medical University of Bialystok
City
Białystok
ZIP/Postal Code
15-089
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All materials and information are available upon an e-mail request on principal investigator
IPD Sharing Time Frame
5 years

Learn more about this trial

GATT Versus Canaloplasty (GVC)

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