Argus II – Información sobre el implante chip en la Clínica Barraquer

Estimad@s compañer@s

Dada la expectación suscitada por la publicación de la noticia de que el Centro Barraquer va a implantar un “chip” para revertir la degeneración de la retina, os adjuntamos toda cuanta información hemos recabado al respecto.

1.    Enlace de la noticia: http://www.europapress.es/salud/asistencia/noticia-centro-barraquer-pionero-espana-implantar-chip-revertir-degeneracion-retina-20131209174737.html

2.    En la web de la Clínica Barraquer: http://www.barraquer.com/es/actualidad/455-vison-artificial.html

3.    En la web de FARPE www.retinosisfarpe.org

Desde FARPE y FUNDALUCE trabajamos para que tengáis la mejor y más fiable información sobre toda la actualidad relacionada con la Retinosis Pigmentaria. Así tras la bomba informativa de estos dias y la aparición en varios medios de comunicación de que la Clínica Barraquer de Barcelona iba a realizar el implante de una retina artificial, creada por la empresa americana Second Sight, y que se conoce como ARGUS II, esta mañana nos hemos puesto en contacto directamente con la clínica para tener información de primera mano.

Hemos hablado con Jordi Prats, Director de Relaciones Públicas de la clínica, que nos ha explicado de forma clara en qué consiste la intervención, todo el proceso que se ha de seguir en Barcelona y las posibilidades de este implante. Desde FARPE y FUNDALUCE le hemos planteado la posibilidad de explicar a los afectados todo lo referente al ARGUS II. Jordi nos ha confirmado que ellos desean lo mismo y que su intención es la de llevar a cabo una campaña de presentación del ARGUS II a nivel nacional. En principio nos ha comentado la posibilidad de dar tres conferencias, una en Barcelona, otra en Madrid y posiblemente otra en Andalucía. FARPE y FUNDALUCE se han comprometido a colaborar en la organización de estas conferencias.

En cuanto al ARGUS II, seguramente ya tenéis mucha información sobre lo que es y en qué consiste. Se trata de una intervención de alrededor de cuatro horas en la que se implanta una especia de microchip. Los pacientes deben llevar unas gafas especiales que cuentan con una cámara de alta definición y un pequeño dispositivo, colgado o en un cinturón, no sé sabe todavia, que sirve para procesar esas imágenes captadas y transmitirlas al microchip implantado.

Tras la intervención, para la que son candidatos personas que solamente perciben luces y sombras, pero que ya no tienen apenas visión, se ha de permanecer en Barcelona durante dos meses para llevar a cabo un aprendizaje o rehabilitación visual y de adaptación al dispositivo. Después de estos dos meses iniciales se habrá de continuar con visitas periódicas a la ciudad condal.

En cuanto al precio, por encima de los 100.000€. La clínica es consciente del elevado precio y argumenta que además del oftalmólogo Jeroni Nadal también participa en la operación un equipo que viene de Estados Unidos y se utilizan materiales también procedentes de EE.UU. lo cual lógicamente encarece el tratamiento. En el ánimo de la clínica está intentar encontrar patrocinadores o sponsors que puedan ayudar a rebajar este precio, aunque es muy pronto para saber nada en este sentido.

Por último desde FARPE queremos hacer un llamamiento a todos los afectados para que estén tranquilos ya que les mantendremos informados de todo lo referente a este tratamiento que llega a España de mano de la Clínica Barraquer. Debéis saber que este tratamiento ofrece la posibilidad de ver algo a personas que apenas tienen ya visión debido a la degeneración de la retina causada por la Retinosis Pigmentaria, pero no debemos pensar que ya es la solución, ya que aunque este tratamiento permite cierta autonomía no ofrece una visión con la calidad suficiente como para poder llevar una vida totalmente normal. Significa otro avance más y hay que estar contentos por ello y esperar que en el futuro sigan surgiendo más y mejores tratamientos para lograr curar esta enfermedad.

4.    En la revista VISION nº 42, pag. 17 podéis encontrar un artículo sobre el Sistema Argus II. En el artículo se da una explicación sencilla sobre que consiste éste “chip”:

NUEVAS OPCIONES TERAPÉUTICAS EN DISTROFIAS RETINIANAS

Sobre el posible tratamiento de las distrofias de retina, ha habido desde un principio tres vías de actuación, el tratamiento farmacológico, incluida   la terapia génica, el tratamiento mediante el uso de sistemas de visión artificial, y el tratamiento mediante reposición biológica, desde el uso de fotorreceptores aislados, laminas completas de epitelio pigmentario de retina, o incluso retinas completas. Voy a destacar por su importante avance en el último año, el uso del sistema Argus II de visión artificial.

El Sistema Argus II de Visión artificial.-

            En un artículo que ya está accesible online y que se publicara a lo largo de este semestre en la revista  British Journal of Ophtalmology, da Cruz y cols.(1) presentan los últimos resultados de un ensayo clínico multicéntrico, en 21 pacientes con restos visuales mínimos (sólo percibían luz), del uso del sistema de visión artificial Argus II (Second Sight Medical Products, Sylmar, California, USA).

El ensayo actual se ha registrado con el identificador NCT00407602. Se ha informado en ensayos anteriores,  que los pacientes demuestran mejora de la movilidad, mejor detección del movimiento y son capaces de distinguir objetos comunes del hogar (2,3). En tareas de orientación y movimiento, los pacientes se dirigieron con éxito hacia una puerta el 58 % de las veces que tenían el sistema encendido, frente a un 32 % con el sistema apagado. En 22 pacientes, el uso del sistema les permitió identificar correctamente letras de una prueba en contexto cerrado el 73 % de las veces, frente al 17 % con el sistema apagado (4,5).

Los pacientes demostraron también una mejoría en las tareas espaciales y motoras, lo que incluye mejorías apreciadas en tareas de localización (6). Hay que destacar que todas las tareas se desarrollaron bajo condiciones controladas, aunque cada vez hay más evidencias de una resolución espacial útil, existe una limitación en el campo de visión proporcionado por el dispositivo. El campo visual en pacientes con un dispositivo protésico está directamente relacionado con el tamaño del área de la retina que se estimula y, por lo tanto, con el diámetro de la matriz de electrodos. Una opción para aumentar el campo de visión consiste en aumentar el tamaño del implante, lo que plantea desafíos de bioingeniería adicionales. Se está evaluando si el dispositivo actual ha tenido como resultado una mejoría en la vida diaria de los pacientes.

El dispositivo Argus II recibió la aprobación para el uso comercial en Europa en marzo del 2011.  Este sistema está basado en la estimulación de la retina residual, principalmente las células ganglionares y bipolares, a través de un sistema de 60 electrodos (array de 6×10, Figura 1C), que recibe información de un procesador de imágenes de video que provienen de una cámara externa que está acoplada a unas gafas que lleva el paciente (Figura 1A). De los 30 pacientes iniciales 9 fueron excluidos por distintas causas, 3 con  problemas con el implante, 1 con hipotonía, 2 que no quisieron participar debido al tiempo que tardaban en el entrenamiento para el test de reconocimiento de letras, y otros 3 por inconsistencia en los entrenamientos del test de reconocimiento de letras (ver tabla 1). Los test realizados fueron tres, el test I,  de reconocimiento de letras blancas sobre fondo negro a un tamaño de 22 cm de altura a 30 cm de distancia, previamente a cada paciente se le enseño cada una de las letras una vez, diciéndole cuál era,.

El test II, era de reducción paulatina de las letras desde 22 cm a 0.5 cm en tramos con un factor de reducción de  reducción de 1,25. El test III, consistió en reconocimientos de palabras de 2 letras a un tamaño de 18 cm de altura, de tres letras a un  tamaño de 14 cm de altura, y de cuatro letras a un tamaño de 11 cm de altura. No hubo ensayo previo para los tests de reducción o de lectura de palabras. Los tests eran realizados en la oscuridad, y las letras eran visualizadas en una presentación de diapositivas en una pantalla LED con una resolución de 1024×768 píxeles (Figura 1B).

La letra usada fue la Century Gothic, para maximizar las posibilidades de reconocimiento, ya que esta letra presenta unas líneas muy finas y permiten diferenciar mejor las distintas letras. Los test II y III, se hicieron en cinco condiciones distintas para descartar falsos positivos y negativos: 1) el sistema apagado y los ojos descubiertos. 2 y 3) el sistema encendido pero en modo aleatorio (sólo detecta luz, pero no posición espacial, Fig. 1D derecha) con los ojos tapados y destapados. 4 y 5) El sistema encendido en modo estándar (detecta luz y posición espacial, Fig 1D izquierda) con los ojos tapados y destapados.

            Los investigadores por tanto han estudiado el sistema desde el punto de vista de la resolución espacial, medida como la capacidad de identificación lectora, y la estabilidad del implante en el tiempo. El resumen de los datos de los sujetos del estudio, como son sexo, edad al diagnóstico, edad a la que se realiza el implante y el tiempo medio del implante, así como los electrodos activados se resume en la Tabla 1 (modificada con permiso de BJO).

            En los resultados obtenidos, como se observa en la Figura 2, existe una significativa diferencia en la capacidad lectora con el aparato funcionando (on) si lo comparamos a cuando está apagado (off). Así, para el grupo de letras A (el menos difícil) como media un 72% de los implantados era capaz de identificarlas con el dispositivo encendido frente a un 18% con el dispositivo apagado. Para el grupo de letras B (dificultad intermedia), un 55% las identificaba con el dispositivo encendido frente a un 12% con el dispositivo apagado. Y para el grupo de letras C (máxima dificultad), un 52% la identificaba con el dispositivo encendido frente a un 15% con el dispositivo apagado. Estas diferencias fueron estadísticamente significativas en todos los grupos.

Los seis individuos con mejor rendimiento en el test I fueron seleccionados para realizar el test II, que servía para determinar el límite del tamaño de la letra que podían identificar. Los sujetos que mejores resultados obtuvieron, fueron capaces de identificar de manera constante letras de tamaños comprendidos entre 2,3  y 22.6 cm de altura, siendo el menor tamaño reconocido fue de 0.9 cm, lo que demuestra que, al menos en algunos sujetos, el sistema funciona al límite de su capacidad teórica en cuanto a resolución espacial se refiere. Para el test III se seleccionaron  cuatro sujetos que al menos acertaron correctamente 10 letras en el test II. Estos cuatro sujetos fueron capaces de leer palabras cortas, lo que demuestra la capacidad de estos sujetos de poder distinguir los componentes de la palabra sin mezclarlos.

A pesar de estos buenos resultados en la  identificación de letras hay que tener en cuenta que el promedio de tiempo utilizado varió entre 6 y 221 segundos según los sujetos, sin que hasta el momento los autores sean capaces de dilucidar el motivo de tal diferencia. El análisis estadístico realizado sugiere que la edad en que se produce el implante se correlaciona con la capacidad lectora, lo que puede ser debido a una mayor proporción de retina con funcionalidad  residual. La edad de diagnóstico y el número de electrodos activados también se correlaciona positivamente con el resultado, aunque debido al pequeño número de pacientes, esta relación no tiene significación estadística. Es importante que en un futuro se puedan aclarar estos factores, ya que ello redundaría en la selección de los pacientes a los que el implante les podría funcionar mejor. Asimismo, no está todavía claro como se podrían trasladar los resultados obtenidos en este estudio a las funciones visuales que tendrían un impacto directo en la vida diaria de los pacientes.

Como conclusión, los autores destacan que el dispositivo cumple con las especificaciones que debe tener un dispositivo biónico para implantar en la retina, de hecho ha sido el primer dispositivo cuyo implante se ha autorizado en Europa aparte de los ensayos clínicos. El dispositivo es portátil, ha permanecido funcional hasta ahora 34 meses y ha sido implantado con éxito en múltiples centros en todo el mundo lo que aumenta la evidencia de que estos dispositivos van a jugar en el futuro  un papel importante en el tratamiento de la pérdida de visión debida a las distrofias de retina.

Fdo.: Dr. Miguel Fernández Burriel. Unidad de Genética, Hospital de Mérida. Director científico de la revista VISIÓN.

Desde Retina Comunidad Valenciana seguiremos informando de todo cuanto surja en torno a esta noticia y todas aquellas que tenga que ver con nuestra patología.

Estamos a vuestra disposición.

Recibid un cordial saludo

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