Glaucoma, Open-AngleNCT05366647
GATT Versus Canaloplasty (GVC)
A study testing canaloplasty and Gonioscopy-assisted Transluminal Trabeculotomy in people with Glaucoma, Open-Angle, run by Medical University of Bialystok at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- canaloplasty and Gonioscopy-assisted Transluminal Trabeculotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years and older (Adult, Older Adult)
- patients with confirmed uncontrolled open angle glaucoma
- no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed
Who cannot join
- angle closure glaucoma
- congenital glaucoma
- inflammatory glaucoma
Trial locations and contacts
1 site in 1 country.
Ewa Kosior-Jarecka contact
Poland1 site, 1 recruiting
- Recruiting
Ophthalmology Clinic Medical University of Bialystok
Bialystok, 15-089
Joanna Konopińska, PhD, 600471666 ext. +48, joannakonopinska@o2.pl
About this study
Official title: Longterm Comparison of Gonioscopy-assisted Transluminal Trabeculotomy and Canaloplasty in Open-angle Glaucoma Treatment
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.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- canaloplasty, Gonioscopy-assisted Transluminal Trabeculotomy
- Keywords
- Gonioscopy-assisted Transluminal Trabeculotomy, Canaloplasty, Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
canaloplastyProcedure or surgery
canaloplasty ab interno with tensioning suture
Gonioscopy-assisted Transluminal TrabeculotomyProcedure or surgery
Gonioscopy-assisted Transluminal Trabeculotomy ab interno
| Study group | Role | What they receive |
|---|---|---|
| Canaloplasty | Active comparator | Canaloplasty ab externo Receives: Procedure: Gonioscopy-assisted Transluminal Trabeculotomy |
| Gonioscopy-assisted Transluminal Trabeculotomy | Active comparator | Gonioscopy-assisted Transluminal Trabeculotomy ab interno Receives: Procedure: canaloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate (complete and qualified success)
Success is defined: 1. IOP < 21 mmHg and at least 20% IOP change from baseline 2. IOP < 18 mmHg
Measured: 12 months
success rate (complete and qualified success)
Success is defined: 1. IOP < 21 mmHg and at least 20% IOP change from baseline 2. IOP < 18 mmHg
Measured: 24 months
Secondary outcomes (2)
IOP, medication, complications
intraocular pressure change, medication postoperatively, complications intra- and postoperatively
Measured: 12 months
IOP, medication, complications
intraocular pressure change, medication postoperatively, complications intra- and postoperatively
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Lublin
- Responsible party
- Principal investigator, Joanna Konopińska, Medical University of Bialystok
- Investigators
- Joanna Konopińska, Principal investigator, Medical University of Bialystok, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366647
- Sponsor's protocol ID
- 1777
- Status last verified
- May 2024
- First submitted
- 4 May 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All materials and information are available upon an e-mail request on principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Comparison of Gonioscopy-assisted Transluminal Trabeculotomy and Canaloplasty in Open-angle Glaucoma Treatment
- ClinicalTrials.gov ID
- NCT05366647
- Acronym / sponsor ID
- 1777
- Conditions
- Glaucoma, Open-Angle
- Keywords
- Gonioscopy-assisted Transluminal Trabeculotomy, Canaloplasty, Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- Medical University of Lublin
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canaloplasty | Active comparator | Procedure: Gonioscopy-assisted Transluminal TrabeculotomyCanaloplasty ab externo |
| Gonioscopy-assisted Transluminal Trabeculotomy | Active comparator | Procedure: canaloplastyGonioscopy-assisted Transluminal Trabeculotomy ab interno |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 Years and older (Adult, Older Adult)
- patients with confirmed uncontrolled open angle glaucoma
- no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed
Key exclusion criteria (3 listed)
- angle closure glaucoma
- congenital glaucoma
- inflammatory glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| canaloplastycanaloplasty ab interno with tensioning suture | Procedure or surgery | Gonioscopy-assisted Transluminal Trabeculotomy |
| Gonioscopy-assisted Transluminal TrabeculotomyGonioscopy-assisted Transluminal Trabeculotomy ab interno | Procedure or surgery | Canaloplasty |
Primary outcome
success rate (complete and qualified success)
Time frame: 12 months
Success is defined: 1. IOP < 21 mmHg and at least 20% IOP change from baseline 2. IOP < 18 mmHg
success rate (complete and qualified success)
Time frame: 24 months
Success is defined: 1. IOP < 21 mmHg and at least 20% IOP change from baseline 2. IOP < 18 mmHg
2 secondary outcomes
IOP, medication, complications
Time frame: 12 months
IOP, medication, complications
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Yes. All materials and information are available upon an e-mail request on principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Kosior-Jarecka contact
Joanna Konopińska principal investigator
Medical University of Bialystok, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing canaloplasty and Gonioscopy-assisted Transluminal Trabeculotomy in people with Glaucoma, Open-Angle, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna Konopińska (+48600471666, joannakonopinska@o2.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (complete and qualified success) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.