Almost all RNFL and disc parameters showed significant differences and discriminated between glaucomatous and normal eyes. There were significant differences in some optic nerve parameters, but no RNFL parameters, between normal and OHT eyes.
Advanced therapy medicinal products (ATMPs) are a group of innovative and complex biological products for human use that comprises somatic cell therapy medicinal products, tissue engineered products, gene therapy medicinal products, and the so-called combined ATMPs that consist of one of the previous three categories combined with one or more medical devices. During the last few years, the development of ATMPs for the treatment of eye diseases has become a fast-growing field as it offers the potential to find novel therapeutic approaches for treating pathologies that today have no cure or are just subjected to symptomatic treatments. Therefore, it is important for all professionals working in this field to be familiar with the regulatory principles associated with these types of innovative products. In this review, we outline the legal framework that regulates the development of ATMPs in the European Union and other international jurisdictions, and the criteria that each type of ATMP must meet to be classified as such. To illustrate each legal definition, ATMPs that have already completed the research and development stages and that are currently used for the treatment of eye diseases are presented as examples.
RESUMENPropósito: Evaluar las dificultades y el grado de aceptación y satisfacción entre la población participante durante una campaña de detección de glaucoma por telemedicina. Este trabajo es parte de un estudio global de desarrollo, aplicación y evaluación del SisGlaTel financiado por el Fondo de Investigaciones Sanitarias (FIS) y Pfizer Ophthalmics. Método: Se desarrolló un sistema de telemedicina sobre un programa específico en JAVA™. Se instaló la estación remota en el Centro de Atención Primaria. Los sujetos participantes firmaron un consentimiento informado, y fueron sometidos a varias pruebas diagnósticas (perimetría de duplicación de frecuencia-FDT, oftalmoscopia con láser confocal-HRT y tonometría). Se analizaron los resultados de las pruebas y los problemas observados en la aplicación del sistema. Se realizó una encuesta a 99 personas que acababan de participar voluntariamente en el programa de detección de glaucoma entre población de riesgo. La encuesta incluyó 7 pregun-ARTÍCULO ORIGINAL ABSTRACT Purpose: To evaluate the problems, and the degree of acceptability and satisfaction among participants in a telemedicine screening program. This study forms part of a global project for the design, implementation and evaluation of SisGlaTel funded by the Fondo de Investigaciones Sanitarias (Spain) and Pfizer Ophthalmics. Method: A telemedicine system was built based on a specific program written in JAVA™. The remote station was located at a Primary Care Center. Participants signed an informed consent, and completed a questionnaire and undertook different tests (frequency doubling perimetry-FDT, confocal scanning laser tomografy-HRT and tonometry). Test results and problems detected were analysed. Ninety-nine subjects completed a satisfaction questionnaire after voluntarily participating in the screening program among an at-risk population. The questionnaire included 7 questions, four of which required participants to categorise their responses, ranging from very bad (1) to excellent (5), to questions
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