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

Официальное название

Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial

Обзор

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

Вмешательства

• Процедура 360º goniotomy assisted transluminal trabeculotomy
  Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork.
• Процедура Phacoemulsification
  Cataract Surgery
• Процедура 180º gonioscopy assisted transluminal trabeculotomy
  Open the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork.

Первичные конечные точки

• Change in intraocular pressure (IOP) after surgery. [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Change in the number of glaucoma medications after surgery. [Срок оценки: From glaucoma medications washout to 2 years after the surgery]

Вторичные конечные точки (9)

• Prognostic factors of the surgeries. [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Prognostic factors of the surgeries. [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Prognostic factors of the surgeries. [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Survival Analysis [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Secundary changes in the eye after the surgeries [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Secundary changes in the eye after the surgeries [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Secundary changes in the eye after the surgeries [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Prognostic factors, and secundary changes in the eye after the surgeries [Срок оценки: From glaucoma medications washout to 2 years after the surgery]
• Secundary changes in the eye after the surgeries [Срок оценки: From glaucoma medications washout to 2 years after the surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais — Belo Horizonte

Идентификаторы

NCT: NCT06865235 · 76604823.8.0000.5134

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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