Publication: Eficacia de la matriz de colágeno Ologen en la cirugía de glaucoma con implante de válvula de Ahmed
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2019-02-18
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Universidad Complutense de Madrid
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Abstract
El glaucoma se define como una neuropatía óptica crónica y progresiva. El factor de riesgo más importante para el desarrollo de glaucoma, así como para su progresión, es una presión intraocular (PIO) elevada. La cirugía suele reservarse para los casos donde el tratamiento con medicación hipotensora tópica no consigue detener la progresión de la enfermedad, cuando existe intolerancia al tratamiento o en casos de glaucomas refractarios a tratamiento médico. Los dispositivos de drenaje (DDD) cada vez son mas utilizados, sobre todo tras el estudio TVT (Tube versus Trabeculectomy) que demostraba mayor tasa de éxito y menor número de re-intervenciones con los dispositivos de drenaje comparado con la trabeculectomía con MMC (mitomicina C) a 5 años de seguimiento. Dentro de los dispositivos valvulados, la válvula de Ahmed (AGV; New World Medical, Inc., Rancho Cucamonga, CA) es la más utilizado en nuestro medio. Una de las limitaciones de este dispositivo comparado con otros es la alta incidencia de fase hipertensiva. Esto ocurre en el 40-80% de los pacientes y ha demostrado que ser un signo de mal pronóstico a medio y largo plazo. Otra complicación de los DDD es la encapsulación de la ampolla. Para tratar de evitar estas complicaciones se han utilizado antimetabolitos intraoperatorios como la mitomicina C (MMC) con resultados controvertidos. Ologen® (Aeon Astron Corporation, Taipei, Taiwán) es una matriz porosa de colágeno biodegradable que se desarrolló con el objetivo de reemplazar a la MMC en cirugía de trabeculectomía (TBCT). Es un modulador de la cicatrización que se coloca bajo de la conjunctiva/tenon, no solo actúa como un reservorio sino que también ayuda a separar mecánicamente la conjuntiva del cuerpo valvular y evita las adherencias entre ellos. Esta matriz, actuando sobre la migración de los fibroblastos, dirige la cicatrización hacia la regeneración del tejido y lejos de la formación de fibrosis. El objetivo de esta tesis fue comparar la eficacia clínica y la seguridad de la matriz de colágeno Ologen en la cirugía de válvula de Ahmed. Este es el primer ensayo clínico prospectivo multicéntrico aleatorizado que evalua la eficacia de la asociación del Ologen a la implantación de válvula de Ahmed en comparación con la cirugía convencional, con el mayor tiempo de seguimiento y en población caucásica...
Glaucoma is defined as a chronic and progressive optic neuropathy. The most important risk factor for the development of glaucoma, as well as its progression, is an elevated intraocular pressure (IOP). Surgery is usually reserved for cases where treatment with topical hypotensive medication fails to stop progression, intolerance to treatment or in cases of glaucoma refractory to medical treatment. Glaucoma drainage devices are commonly used in glaucoma surgery specially after the TVT study that showed a higher success rate and lower rate of reoperations of tube shunt surgery compared to trabeculectomy with MMC at 5 years follow-up. Rancho Cucamonga, CA) in comparison to other devices is a high incidence of hypertensive phase. This occurs in 40-80% of patients and is normally due the blebs fibrosis and inflammation. It is proved to be an unfavorable prognostic sign and may actually represent imminent failures. Another tube-specific complication is the development of bleb encapsulation. To try to avoid these complications antimetabolites, such as intraoperative mitomycin-C (MMC), have been used with controversial results. Ologen (Aeon Astron Corporation, Taipei, Taiwan) is a biodegradable collagen porous matrix that was developed aiming to replace MMC for trabeculectomy. When placed under de conjunctiva, it not only acts as a reservoir but also helps to separate mechanically the conjunctiva from the valve´s plate and prevent adhesions between them. This technique directs wound healing towards tissue regeneration and away from scar formation by guiding the patterns of fibroblasts migration. The aim of the study was to compare the clinical efficacy and safety of Ologen in AGV surgery. To the best of our knowledge this is the first randomized multicentre clinical trial to evaluate Ologen with AGV implantation as compared with standard surgery, with the longest follow-up, and in Caucasian population...
Glaucoma is defined as a chronic and progressive optic neuropathy. The most important risk factor for the development of glaucoma, as well as its progression, is an elevated intraocular pressure (IOP). Surgery is usually reserved for cases where treatment with topical hypotensive medication fails to stop progression, intolerance to treatment or in cases of glaucoma refractory to medical treatment. Glaucoma drainage devices are commonly used in glaucoma surgery specially after the TVT study that showed a higher success rate and lower rate of reoperations of tube shunt surgery compared to trabeculectomy with MMC at 5 years follow-up. Rancho Cucamonga, CA) in comparison to other devices is a high incidence of hypertensive phase. This occurs in 40-80% of patients and is normally due the blebs fibrosis and inflammation. It is proved to be an unfavorable prognostic sign and may actually represent imminent failures. Another tube-specific complication is the development of bleb encapsulation. To try to avoid these complications antimetabolites, such as intraoperative mitomycin-C (MMC), have been used with controversial results. Ologen (Aeon Astron Corporation, Taipei, Taiwan) is a biodegradable collagen porous matrix that was developed aiming to replace MMC for trabeculectomy. When placed under de conjunctiva, it not only acts as a reservoir but also helps to separate mechanically the conjunctiva from the valve´s plate and prevent adhesions between them. This technique directs wound healing towards tissue regeneration and away from scar formation by guiding the patterns of fibroblasts migration. The aim of the study was to compare the clinical efficacy and safety of Ologen in AGV surgery. To the best of our knowledge this is the first randomized multicentre clinical trial to evaluate Ologen with AGV implantation as compared with standard surgery, with the longest follow-up, and in Caucasian population...
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Tesis de la Universidad Complutense de Madrid, Facultad de Medicina, Departamento de Inmunología, Oftalmología y Otorrinolaringología, leída el 13/12/2018