Clinical trial NCT06865235: Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.
Official title: Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Open Angle Glaucoma (OAG)
Keywords: Open angle glaucoma
Cataract
OAG
Goniotomy assisted transluminal trabeculotomy
GATT
trabeculotomy
Goniotomy
hemi-gatt
Lead sponsor: Faculdade de Ciências Médicas de Minas Gerais
Sponsor class: OTHER
Collaborators: name: Hospital Evangélico de Belo Horizonte
First posted: 2025-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in intraocular pressure (IOP) after surgery.
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Change in the number of glaucoma medications after surgery.
timeFrame: From glaucoma medications washout to 2 years after the surgery
Secondary outcomes:
measure: Prognostic factors of the surgeries.
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Prognostic factors of the surgeries.
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Prognostic factors of the surgeries.
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Survival Analysis
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Secundary changes in the eye after the surgeries
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Secundary changes in the eye after the surgeries
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Secundary changes in the eye after the surgeries
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Prognostic factors, and secundary changes in the eye after the surgeries
timeFrame: From glaucoma medications washout to 2 years after the surgery
measure: Secundary changes in the eye after the surgeries
timeFrame: From glaucoma medications washout to 2 years after the surgery
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais
state: Minas Gerais
Study officials:
References: