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

NCT06865235 | Recruiting

• 1 other identifier: 76604823.8.0000.5134
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Open Angle Glaucoma (OAG)

Keywords

Open angle glaucoma; Cataract; OAG; Goniotomy assisted transluminal trabeculotomy; GATT; trabeculotomy; Goniotomy; hemi-gatt

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Prognostic factors of the surgeries.

  From glaucoma medications washout to 2 years after the surgery

• Prognostic factors of the surgeries.

  From glaucoma medications washout to 2 years after the surgery

• Prognostic factors of the surgeries.

  From glaucoma medications washout to 2 years after the surgery

• Survival Analysis

  From glaucoma medications washout to 2 years after the surgery

• Secundary changes in the eye after the surgeries

  From glaucoma medications washout to 2 years after the surgery

Study Arms (3)

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

Control Group

Procedure: Phacoemulsification

Interventions

360º goniotomy assisted transluminal trabeculotomy PROCEDURE

Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork.

Patients undergoing cataract surgery associated with GATT by 360º

Phacoemulsification PROCEDURE

Cataract 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 trabeculotomy PROCEDURE

Open the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork.

Also known as: 180º GATT, Hemi - GATT

Patients undergoing cataract surgery associated with GATT by 180º

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculdade de Ciências Médicas de Minas Gerais: lead
• Hospital Evangélico de Belo Horizonte: collaborator

Study Sites (1)

Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais

Belo Horizonte, Minas Gerais, 30150270, Brazil

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Central Study Contacts

Daniel F Moura, MD

CONTACT

+5531991055860; dfmoftalmo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The researcher who measures IOP
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Glaucoma Department

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: March 7, 2025
• Study Start: May 7, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BR (1)