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
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")).
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;
Parallel
360º goniotomy assisted transluminal trabeculotomy
Procedure/SurgeryOpen the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork.
Phacoemulsification
Procedure/SurgeryCataract Surgery
180º gonioscopy assisted transluminal trabeculotomy
Procedure/SurgeryOpen the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork.
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.
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.
Prognostic factors of the surgeries.
Evaluate the association of IOP variation with axial eye length (AXL) in the groups.
Prognostic factors of the surgeries.
Evaluate the association of IOP variation with preoperative anterior chamber amplitude (ACD) in the groups.
Prognostic factors of the surgeries.
Evaluate the association of IOP variation with age in the groups
Survival Analysis
Evaluate and compare the need for new glaucoma surgeries between the groups.
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Faculdade de Ciências Médicas de Minas Gerais
Lead sponsor
Hospital Evangélico de Belo Horizonte
Collaborator
