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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorFaculdade de Ciências Médicas de Minas Gerais

About this 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

Eligibility criteria

Qualifiers

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")).

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • 360º goniotomy assisted transluminal trabeculotomy
  • Phacoemulsification
  • 180º gonioscopy assisted transluminal trabeculotomy

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Faculdade de Ciências Médicas de Minas Gerais

Lead sponsor

Hospital Evangélico de Belo Horizonte

Collaborator