Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.

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

Study Overview

• Status: Recruiting
• Conditions: Open Angle Glaucoma (OAG)
• Intervention / Treatment: Procedure: 360º goniotomy assisted transluminal trabeculotomy; Procedure: Phacoemulsification; Procedure: 180º gonioscopy assisted transluminal trabeculotomy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel F Moura, MD; Phone Number: +5531991055860; Email: dfmoftalmo@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150270
      • Recruiting
      • Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais
      • Contact: Bruno L Trindade, PhD; Phone Number: +553132487450; Email: bruno.trindade@feluma.org.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients undergoing cataract surgery associated with GATT by 360º	Procedure: 360º goniotomy assisted transluminal trabeculotomy; Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork.; Procedure: Phacoemulsification; Cataract Surgery
Experimental: Patients undergoing cataract surgery associated with GATT by 180º	Procedure: Phacoemulsification; Cataract Surgery; Procedure: 180º gonioscopy assisted transluminal trabeculotomy; Open the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork.; Other Names: 180º GATT; Hemi - GATT
Other: Patients undergoing only cataract surgery; Control Group	Procedure: Phacoemulsification; Cataract Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From glaucoma medications washout to 2 years after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic factors of the surgeries.	Evaluate the association of IOP variation with axial eye length (AXL) in the groups.	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.	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	From glaucoma medications washout to 2 years after the surgery
Survival Analysis	Evaluate and compare the need for new glaucoma surgeries between the groups.	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.	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.	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.	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.	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	From glaucoma medications washout to 2 years after the surgery

Collaborators and Investigators

• Sponsor: Faculdade de Ciências Médicas de Minas Gerais
• Collaborators: Hospital Evangélico de Belo Horizonte

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cataract; Open angle glaucoma; OAG; Goniotomy; trabeculotomy; GATT; Goniotomy assisted transluminal trabeculotomy; hemi-gatt
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Ocular Hypertension; Cataract; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 76604823.8.0000.5134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD collected throughout the trial
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No