Open Angle Glaucoma (OAG)NCT06865235
Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.
A study testing 360º goniotomy assisted transluminal trabeculotomy, Phacoemulsification and 180º gonioscopy assisted transluminal trabeculotomy in people with Open Angle Glaucoma (OAG), run by Faculdade de Ciências Médicas de Minas Gerais at 1 site in Brazil.
Trial summary
Prospective, randomized, , double-blind, clinical trial, comparing the variation of intraocular pressure (IOP) of patients with mild or moderate primary open-angle glaucoma (OAG) and cataract divided into three groups. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma (OAG)
- What is being tested?
- 360º goniotomy assisted transluminal trabeculotomy, Phacoemulsification and 180º gonioscopy assisted transluminal trabeculotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 7 May 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 years or older,
- Previously included in the glaucoma departments of the participating institutions,
- Indication for cataract surgery, diagnosed by clinical examination with visual acuity (VA) equal to or worse than 20/40,
- Primary Open Angle Glaucoma (POAG), determined by the presence of typical visual field (VF) defects and/or by the aspect of the optic nerve observed at fundoscopy or retinography (increased vertical optical excavation with thinning of the neural rhyme, asymmetry of the cup/disc ratio greater than 0.2, localized loss ("notch") or defect in the retinal nerve fiber layer ("Hoyt")).
- APIC classification with amplitude greater/equal to 2 and pigmentation less than 4 on gonioscopy.
- Intraocular pressure (IOP) less than or equal to 25 mmHg before washout of hypotensive eye drops.
- IOP between 22 and 30 mmHg after washout of hypotensive eye drops or with a history of IOP greater than or equal to 21 mmHg in more than one previous care described in the medical record.
Who cannot join
- Patients who have any of the following situations:
- Severe glaucoma, determined according to the Hoddap-Parrish-Anderson criteria;
- Axial diameter greater than 26 mm or less than 21.00 mm;
- Endothelial count less than 1500 cc;
- Pachymetry less than 480 or greater than 600 microns;
- Patients undergoing some type of intraocular surgery or laser procedure in the preoperative period and/or after these procedures in the postoperative period;
- Those who present some important per-operative complication during the study.
- With high risk of progression, the so-called rapid progressors, who are patients with high IOPs even with the use of many medications, regardless of the severity of the nerve injury.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais
Belo Horizonte, Minas Gerais, 30150270
Bruno L Trindade, PhD, +553132487450, bruno.trindade@feluma.org.br
About this study
Official title: Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial
Prospective, randomized, , double-blind, clinical trial, comparing the variation of intraocular pressure (IOP) of patients with mild or moderate primary open-angle glaucoma (OAG) and cataract divided into three groups. All study participants should be treated for the pathology with one or more hypotensive medications or, regardless of the number of drugs, when IOP is greater than 20 mmHg and less than 26 mmHg. The two-year follow-up should also compare the reduction in the number of medications used, reoperation rate, adverse effects, visual acuity, endothelial loss, induction of astigmatism, variation in IOP according to axial diameter of the eye, anterior chamber and age, in addition to the existence of change in the quality of life of patients in the postoperative period
- Conditions
- Open Angle Glaucoma (OAG)
- Being tested
- 360º goniotomy assisted transluminal trabeculotomy, Phacoemulsification, 180º gonioscopy assisted transluminal trabeculotomy
- Keywords
- Open angle glaucoma, Cataract, OAG, Goniotomy assisted transluminal trabeculotomy, GATT, trabeculotomy, Goniotomy, hemi-gatt
- Medical subject headings
- Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360º goniotomy assisted transluminal trabeculotomyProcedure or surgery
Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork.
PhacoemulsificationProcedure or surgery
Cataract Surgery
180º gonioscopy assisted transluminal trabeculotomyProcedure or surgery
Also called 180º GATT, Hemi - GATT
Open the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cataract surgery associated with GATT by 360º | Experimental | Not described Receives: Procedure: 360º goniotomy assisted transluminal trabeculotomy; Procedure: Phacoemulsification |
| Patients undergoing cataract surgery associated with GATT by 180º | Experimental | Not described Receives: Procedure: Phacoemulsification; Procedure: 180º gonioscopy assisted transluminal trabeculotomy |
| Patients undergoing only cataract surgery | Other | Control Group Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intraocular pressure (IOP) after surgery.
To evaluate the change in intraocular pressure (IOP) after surgery, in patients with mild to moderate GPAA, undergoing phacoemulsification associated with gonioscopy assisted transluminal trabeculotomy by 180º (GATT 180º) or 360º (GATT 360º), and compare the results between the groups mentioned and with similar controls, who operated only on cataracts, in a period of up to two years.
Measured: From glaucoma medications washout to 2 years after the surgery
Change in the number of glaucoma medications after surgery.
To evaluate the change in the number of glaucoma medications applied after surgery, in patients with mild to moderate GPAA, undergoing phacoemulsification associated with gonioscopy assisted transluminal trabeculotomy by 180º (GATT 180º) or 360º (GATT 360º), and compare the results between the groups mentioned and with similar controls, who operated only on cataracts, in a period of up to two years.
Measured: From glaucoma medications washout to 2 years after the surgery
Secondary outcomes (9)
Prognostic factors of the surgeries.
Evaluate the association of IOP variation with axial eye length (AXL) in the groups.
Measured: From glaucoma medications washout to 2 years after the surgery
Prognostic factors of the surgeries.
Evaluate the association of IOP variation with preoperative anterior chamber amplitude (ACD) in the groups.
Measured: From glaucoma medications washout to 2 years after the surgery
Prognostic factors of the surgeries.
Evaluate the association of IOP variation with age in the groups
Measured: From glaucoma medications washout to 2 years after the surgery
Survival Analysis
Evaluate and compare the need for new glaucoma surgeries between the groups.
Measured: From glaucoma medications washout to 2 years after the surgery
Secundary changes in the eye after the surgeries
Evaluate the visual acuity after the surgeries and compare between them.
Measured: From glaucoma medications washout to 2 years after the surgery
Secundary changes in the eye after the surgeries
Evaluate and compare the adverse events after the surgeries.
Measured: From glaucoma medications washout to 2 years after the surgery
Secundary changes in the eye after the surgeries
Evaluate the decrease in corneal endothelial cell count between the groups.
Measured: From glaucoma medications washout to 2 years after the surgery
Prognostic factors, and secundary changes in the eye after the surgeries
Evaluate and compare the change in quality of life in and between the groups.
Measured: From glaucoma medications washout to 2 years after the surgery
Secundary changes in the eye after the surgeries
Evaluate the induction of astigmatism between the groups
Measured: From glaucoma medications washout to 2 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start7 May 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma (OAG)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas de Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Evangélico de Belo Horizonte
- Responsible party
- Principal investigator, DANIEL FULGENCIO DE MOURA, Faculdade de Ciências Médicas de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865235
- Sponsor's protocol ID
- 76604823.8.0000.5134
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- 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 IPD collected throughout the trial
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
- Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06865235
- Acronym / sponsor ID
- 76604823.8.0000.5134
- Conditions
- Open Angle Glaucoma (OAG)
- Keywords
- Open angle glaucoma, Cataract, OAG, Goniotomy assisted transluminal trabeculotomy, GATT, trabeculotomy, Goniotomy, hemi-gatt
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Faculdade de Ciências Médicas de Minas GeraisUniversity, hospital or other
- Collaborators
- Hospital Evangélico de Belo Horizonte
- Study start
- 7 May 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Mar 2025 (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.
Prospective, randomized, , double-blind, clinical trial, comparing the variation of intraocular pressure (IOP) of patients with mild or moderate primary open-angle glaucoma (OAG) and cataract divided into three groups. All study participants should be treated for the pathology with one or more hypotensive medications or, regardless of the number of drugs, when IOP is greater than 20 mmHg and less than 26 mmHg. The two-year follow-up should also compare the reduction in the number of medications used, reoperation rate, adverse effects, visual acuity, endothelial loss, induction of astigmatism, variation in IOP according to axial diameter of the eye, anterior chamber and age, in addition to the existence of change in the quality of life of patients in the postoperative period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cataract surgery associated with GATT by 360º | Experimental | Procedure: 360º goniotomy assisted transluminal trabeculotomy, Procedure: Phacoemulsification |
| Patients undergoing cataract surgery associated with GATT by 180º | Experimental | Procedure: Phacoemulsification, Procedure: 180º gonioscopy assisted transluminal trabeculotomy |
| Patients undergoing only cataract surgery | Other | Procedure: PhacoemulsificationControl Group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 40 years or older,
- Previously included in the glaucoma departments of the participating institutions,
- Indication for cataract surgery, diagnosed by clinical examination with visual acuity (VA) equal to or worse than 20/40,
- Primary Open Angle Glaucoma (POAG), determined by the presence of typical visual field (VF) defects and/or by the aspect of the optic nerve observed at fundoscopy or retinography (increased vertical optical excavation with thinning of the neural rhyme, asymmetry of the cup/disc ratio greater than 0.2, localized loss ("notch") or defect in the retinal nerve fiber layer ("Hoyt")).
- APIC classification with amplitude greater/equal to 2 and pigmentation less than 4 on gonioscopy.
Key exclusion criteria (8 listed)
- Severe glaucoma, determined according to the Hoddap-Parrish-Anderson criteria;
- Axial diameter greater than 26 mm or less than 21.00 mm;
- Endothelial count less than 1500 cc;
- Pachymetry less than 480 or greater than 600 microns;
- Patients undergoing some type of intraocular surgery or laser procedure in the preoperative period and/or after these procedures in the postoperative period;
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 |
|---|---|---|
| 360º goniotomy assisted transluminal trabeculotomyOpen the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork. | Procedure or surgery | Patients undergoing cataract surgery associated with GATT by 360º |
| PhacoemulsificationCataract Surgery | Procedure or surgery | Patients undergoing cataract surgery associated with GATT by 180º, Patients undergoing cataract surgery associated with GATT by 360º, Patients undergoing only cataract surgery |
| 180º gonioscopy assisted transluminal trabeculotomyAlso: 180º GATT, Hemi - GATTOpen the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork. | Procedure or surgery | Patients undergoing cataract surgery associated with GATT by 180º |
Primary outcome
Change in intraocular pressure (IOP) after surgery.
Time frame: From glaucoma medications washout to 2 years after the surgery
To evaluate the change in intraocular pressure (IOP) after surgery, in patients with mild to moderate GPAA, undergoing phacoemulsification associated with gonioscopy assisted transluminal trabeculotomy by 180º (GATT 180º) or 360º (GATT 360º), and compare the results between the groups mentioned and with similar controls, who operated only on cataracts, in a period of up to two years.
Change in the number of glaucoma medications after surgery.
Time frame: From glaucoma medications washout to 2 years after the surgery
To evaluate the change in the number of glaucoma medications applied after surgery, in patients with mild to moderate GPAA, undergoing phacoemulsification associated with gonioscopy assisted transluminal trabeculotomy by 180º (GATT 180º) or 360º (GATT 360º), and compare the results between the groups mentioned and with similar controls, who operated only on cataracts, in a period of up to two years.
9 secondary outcomes
Prognostic factors of the surgeries.
Time frame: From glaucoma medications washout to 2 years after the surgery
Prognostic factors of the surgeries.
Time frame: From glaucoma medications washout to 2 years after the surgery
Prognostic factors of the surgeries.
Time frame: From glaucoma medications washout to 2 years after the surgery
Survival Analysis
Time frame: From glaucoma medications washout to 2 years after the surgery
Secundary changes in the eye after the surgeries
Time frame: From glaucoma medications washout to 2 years after the surgery
Secundary changes in the eye after the surgeries
Time frame: From glaucoma medications washout to 2 years after the surgery
Secundary changes in the eye after the surgeries
Time frame: From glaucoma medications washout to 2 years after the surgery
Prognostic factors, and secundary changes in the eye after the surgeries
Time frame: From glaucoma medications washout to 2 years after the surgery
Secundary changes in the eye after the surgeries
Time frame: From glaucoma medications washout to 2 years after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 360º goniotomy assisted transluminal trabeculotomy, Phacoemulsification and 180º gonioscopy assisted transluminal trabeculotomy in people with Open Angle Glaucoma (OAG), run by Faculdade de Ciências Médicas de Minas Gerais at 1 site in Brazil.
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 7 inclusion and 8 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: looking for participants now, 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel F Moura, MD (+5531991055860, dfmoftalmo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intraocular pressure (IOP) after surgery. (time frame: From glaucoma medications washout to 2 years after the surgery). 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.