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

Faculdade de Ciências Médicas de Minas Gerais

Status: Enrolling

Conditions: Open Angle Glaucoma (OAG)

Treatments: Procedure: Phacoemulsification; Procedure: 360º goniotomy assisted transluminal trabeculotomy; Procedure: 180º gonioscopy assisted transluminal trabeculotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06865235

76604823.8.0000.5134

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Patients undergoing cataract surgery associated with GATT by 360º

Experimental group

Treatment:

Procedure: 360º goniotomy assisted transluminal trabeculotomy

Procedure: Phacoemulsification

Patients undergoing cataract surgery associated with GATT by 180º

Experimental group

Treatment:

Procedure: 180º gonioscopy assisted transluminal trabeculotomy

Procedure: Phacoemulsification

Patients undergoing only cataract surgery

Other group

Description:

Control Group

Treatment:

Procedure: Phacoemulsification