Back to resultsGATT 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
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Gonioscopy-assisted Transluminal Trabeculotomy, Canaloplasty, Glaucoma
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
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
NCT ID
NCT05366647
First Posted
May 4, 2022
Last Updated
May 4, 2022
Sponsor
Medical University of Bialystok
Collaborators
Medical University of Lublin
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)
We'll reach out to this number within 24 hrs