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

NCT ID: NCT06865235

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2028-02-29

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patients undergoing cataract surgery associated with GATT by 360º

Group Type: EXPERIMENTAL

360º goniotomy assisted transluminal trabeculotomy

Intervention Type: PROCEDURE

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

Phacoemulsification

Intervention Type: PROCEDURE

Cataract Surgery

Patients undergoing cataract surgery associated with GATT by 180º

Group Type: EXPERIMENTAL

Phacoemulsification

Intervention Type: PROCEDURE

Cataract Surgery

180º gonioscopy assisted transluminal trabeculotomy

Intervention Type: PROCEDURE

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

Patients undergoing only cataract surgery

Control Group

Group Type: OTHER

Phacoemulsification

Intervention Type: PROCEDURE

Cataract Surgery

Interventions

360º goniotomy assisted transluminal trabeculotomy

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

Intervention Type: PROCEDURE

Phacoemulsification

Cataract Surgery

Intervention Type: PROCEDURE

180º gonioscopy assisted transluminal trabeculotomy

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

Intervention Type: PROCEDURE

Other Intervention Names

180º GATT; Hemi - GATT

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Evangélico de Belo Horizonte

UNKNOWN

Sponsor Role: collaborator

Faculdade de Ciências Médicas de Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

DANIEL FULGENCIO DE MOURA

Head of the Glaucoma Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Belo Horizonte, Minas Gerais, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Daniel F Moura, MD

Role: CONTACT

dfmoftalmo@gmail.com

+5531991055860

Facility Contacts

Bruno L Trindade, PhD

Role: primary

bruno.trindade@feluma.org.br

+553132487450

Other Identifiers

76604823.8.0000.5134

Identifier Type: -

Identifier Source: org_study_id