Publication: Estudio comparativo de facoemulsificación de catarata más trabeculotomía ab interno (Kahook Dual Blade) vs facoemulsificación de catarata para el control de la presión intraocular
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2021-07-15
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Universidad Complutense de Madrid
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Abstract
El glaucoma es una de las principales causas de ceguera irreversible a nivel mundial. Aunque es difícil determinar la prevalencia exacta, se estima que afecta a entre un 1,1- 2,3% de la población mundial. Son varios los factores de riesgo que pueden predisponer al desarrollo de glaucoma, pero la presión intraocular (PIO) es el único modificable que puede enlentecer la progresión de la enfermedad. En condiciones de funcionamiento fisiológico, el humor acuoso se elimina a través de dos vías, la vía supracoroidea y la convencional o vía trabecular. Hasta la fecha, la vía convencional, que implica al tejido trabecular, el conducto de Schlemm, los canales colectores y las venas acuosas, es la causa principal del incremento de la PIO, debido al aumento de la resistencia a su salida y la rigidez en el drenaje normal del humor acuoso. El tratamiento quirúrgico se plantea cuando el tratamiento farmacológico o el láser no logran una reducción significativa de la PIO, el tratamiento no es tolerado por el paciente, o la enfermedad se diagnostica en estadios avanzados en los que otra alternativa abocaría a la ceguera. En estos casos, las cirugías filtrantes y los dispositivos de drenaje son aún el patrón oro, debido a su eficacia en la reducción de la presión y del número de fármacos necesarios. Estas cirugías son el patrón oro y han sido mejoradas para tener un perfil de seguridad mayor; sin embargo, presentan complicaciones graves que pueden amenazar a la visión. Durante la última década, ha aumentado el interés por las denominadas cirugías mínimamente invasivas en glaucoma (MIGS, de sus siglas en inglés). Estas cirugías deben tener, entre sus características, generar un daño mínimo al tejido diana, eficacia moderada, un perfil de seguridad elevado y recuperación rápida tras la cirugía, entre otros. Las MIGS se clasifican en función de la vía sobre la que actúan. Aquellas que abordan la vía trabecular presentan dos ventajas concretas: habitualmente requieren poca manipulación, y pueden puentear o directamente eliminar la malla trabecular. El Kahook Dual Blade® (KDB; New World Medical, Rancho Cucamonga, CA, EE.UU.) es un dispositivo de un solo uso, formado por dos cuchillas de corte especialmente diseñadas para eliminar casi completamente la malla trabecular del área tratada. Las investigaciones preclínicas mostraron que este diseño permite eliminar el tejido trabecular y favorecer la salida de humor acuoso, sin dañar los tejidos adyacentes. En la práctica clínica, la trabeculotomía ab interno con KDB, combinada con la cirugía de cataratas, parece haber logrado un descenso significativo de la PIO, a medio plazo. OBJETIVOS: Determinar la eficacia y seguridad de la trabeculotomía ab interno con KDB, combinado con cirugía de catarata estándar. Objetivo primario: evaluar la reducción de la PIO y del número de fármacos antiglaucomatosos, y compararlo con el efecto logrado por la cirugía de cataratas...
Glaucoma is one of the leading causes of irreversible blindness worldwide. Although the exact prevalence is difficult to determine, glaucoma is estimated to affect about 1.1-2.3% of the world’s population. Although several risk factors can predispose to develop glaucoma, it is the increased intraocular pressure (IOP) the only modifiable that can slow disease progression. In normal functioning, aqueous humor outflows in two different ways, the suprachoroidal pathway and the conventional pathway. To date, the conventional pathway, involving the trabecular meshwork, Schlemm’s canal, collector channels and aqueous veins, is the main responsible of the elevated IOP, due to an increased resistance and stiffness in normal drainage of the aqueous humor. Surgical treatment is considered when glaucoma eyedrops or laser treatments do not achieve a significant reduction in IOP, glaucoma eyedrops are no longer tolerated or the disease is diagnosed at a such an end-stage phase that any other options would lead to a complete loss of the visual field. In those scenarios, filtering surgeries and glaucoma drainage devices remain the preferred treatment options due to their efficacy in reducing IOP and the limited amount of glaucoma medications needed after surgery. Although they are the surgical refence in glaucoma surgery and several safety mechanisms have been developed, potential sight-threatening complications from these procedures have led into new surgical options. Over the last decade, there has been an increasing interest in micro-invasive glaucoma surgeries (MIGS). MIGS are defined as a surgical option that would result in minimal trauma to the target tissue, had at least modest efficacy, a high safety profile and rapid recovery after surgery. MIGS are further classified according to the anatomical or functional pathway they approach. Those MIGS that act on the trabecular meshwork are both theoretically and practically appealing due to two main reasons: they usually require minimal intraocular manipulation, and can either bypass or remove the trabecular meshwork. The Kahook Dual Blade® (KDB; New World Medical, Rancho Cucamonga, CA, USA) is a novel, single-use dual blade specially designed to almost completely eliminate the TM with a single cut. Preclinical investigation has demonstrated that the dual blade allows both removal of the TM and increased aqueous outflow with a gentle effect on surroundings tissues. In real-life practice, ab interno trabeculectomy with the KDB combined with cataract surgery has achieved a significant mid-term reduction in IOP. OBJECTIVES: To determine the efficacy and safety of the ab interno trabeculectomy with KDB combined with standard cataract surgery. Primary objective: to evaluate the reduction in intraocular pressure and number of glaucoma medications achieved with ab interno trabeculectomy with Kahook Dual Blade, combined with standard cataract surgery. To compare this reduction with the cut-off achieved with standard cataract surgery alone...
Glaucoma is one of the leading causes of irreversible blindness worldwide. Although the exact prevalence is difficult to determine, glaucoma is estimated to affect about 1.1-2.3% of the world’s population. Although several risk factors can predispose to develop glaucoma, it is the increased intraocular pressure (IOP) the only modifiable that can slow disease progression. In normal functioning, aqueous humor outflows in two different ways, the suprachoroidal pathway and the conventional pathway. To date, the conventional pathway, involving the trabecular meshwork, Schlemm’s canal, collector channels and aqueous veins, is the main responsible of the elevated IOP, due to an increased resistance and stiffness in normal drainage of the aqueous humor. Surgical treatment is considered when glaucoma eyedrops or laser treatments do not achieve a significant reduction in IOP, glaucoma eyedrops are no longer tolerated or the disease is diagnosed at a such an end-stage phase that any other options would lead to a complete loss of the visual field. In those scenarios, filtering surgeries and glaucoma drainage devices remain the preferred treatment options due to their efficacy in reducing IOP and the limited amount of glaucoma medications needed after surgery. Although they are the surgical refence in glaucoma surgery and several safety mechanisms have been developed, potential sight-threatening complications from these procedures have led into new surgical options. Over the last decade, there has been an increasing interest in micro-invasive glaucoma surgeries (MIGS). MIGS are defined as a surgical option that would result in minimal trauma to the target tissue, had at least modest efficacy, a high safety profile and rapid recovery after surgery. MIGS are further classified according to the anatomical or functional pathway they approach. Those MIGS that act on the trabecular meshwork are both theoretically and practically appealing due to two main reasons: they usually require minimal intraocular manipulation, and can either bypass or remove the trabecular meshwork. The Kahook Dual Blade® (KDB; New World Medical, Rancho Cucamonga, CA, USA) is a novel, single-use dual blade specially designed to almost completely eliminate the TM with a single cut. Preclinical investigation has demonstrated that the dual blade allows both removal of the TM and increased aqueous outflow with a gentle effect on surroundings tissues. In real-life practice, ab interno trabeculectomy with the KDB combined with cataract surgery has achieved a significant mid-term reduction in IOP. OBJECTIVES: To determine the efficacy and safety of the ab interno trabeculectomy with KDB combined with standard cataract surgery. Primary objective: to evaluate the reduction in intraocular pressure and number of glaucoma medications achieved with ab interno trabeculectomy with Kahook Dual Blade, combined with standard cataract surgery. To compare this reduction with the cut-off achieved with standard cataract surgery alone...
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Tesis inédita de la Universidad Complutense de Madrid, Facultad de Medicina, Departamento de Inmunología, Oftalmología y Otorrinolaringología, leída el 23/03/2021