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

Last updated: March 5, 2025
Sponsor: Faculdade de Ciências Médicas de Minas Gerais
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Eye Disease

Eye Disorders/infections

Treatment

180º gonioscopy assisted transluminal trabeculotomy

360º goniotomy assisted transluminal trabeculotomy

Phacoemulsification

Clinical Study ID

NCT06865235
76604823.8.0000.5134
  • Ages > 40
  • All Genders

Study 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

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 visualacuity (VA) equal to or worse than 20/40,

  • Primary Open Angle Glaucoma (POAG), determined by the presence of typical visualfield (VF) defects and/or by the aspect of the optic nerve observed at fundoscopy orretinography (increased vertical optical excavation with thinning of the neuralrhyme, asymmetry of the cup/disc ratio greater than 0.2, localized loss ("notch") ordefect in the retinal nerve fiber layer ("Hoyt")).

  • APIC classification with amplitude greater/equal to 2 and pigmentation less than 4on gonioscopy.

  • Intraocular pressure (IOP) less than or equal to 25 mmHg before washout ofhypotensive eye drops.

  • IOP between 22 and 30 mmHg after washout of hypotensive eye drops or with a historyof IOP greater than or equal to 21 mmHg in more than one previous care described inthe medical record.

Exclusion

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 thepreoperative 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 patientswith high IOPs even with the use of many medications, regardless of the severity ofthe nerve injury.

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: 180º gonioscopy assisted transluminal trabeculotomy
Phase:
Study Start date:
May 07, 2024
Estimated Completion Date:
February 29, 2028

Connect with a study center

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

    Belo Horizonte, Minas Gerais 30150270
    Brazil

    Active - Recruiting

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