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    Por favor, use este identificador para citar o enlazar este ítem:https://uvadoc.uva.es/handle/10324/68869

    Título
    Acute retinal toxicity associated with a mixture of perfluorooctane and perfluorohexyloctane: failure of another indirect cytotoxicity analysis
    Autor
    Coco Martín, Rosa MaríaAutoridad UVA Orcid
    Srivastava, Girish KumarAutoridad UVA Orcid
    Andrés Iglesias, CristinaAutoridad UVA Orcid
    Medina García, JesúsAutoridad UVA
    Rull Pérez, FernandoAutoridad UVA
    Fernandez-Vega-González, Alvaro
    Fernández Bueno, IvánAutoridad UVA
    Dueñas Laita, AntonioAutoridad UVA
    Pastor Jimeno, José CarlosAutoridad UVA
    Año del Documento
    2019-01
    Editorial
    British Medical Association
    Descripción
    Producción Científica
    Documento Fuente
    British Journal of Ophthalmology, Jan, 2019, vol. 103, n. 1, p. 49-54.
    Abstract
    ABSTRACT: AIMS To report new information related to acute retinal toxicity of Bio Octane Plus®, a mixture of 90% perfluorooctane (PFO) and 10% perfluorohexyloctane. METHODS This retrospective, descriptive case series reports the occurrence of acute retinal toxicity after vitreoretinal surgery in which Bio Octane Plus® (batch 1605148) was used as an endotamponade. Cytotoxicity biocompatibility tests and chemical analyses by Fourier-transformed infrared spectroscopy (FTIR) and gas chromatography-mass spectrometry (GC-MS) of the presumed toxic product were performed. RESULTS Four patients presented with acute severe visual loss after uneventful ocular surgery assisted by Bio Octane Plus® (batch 1605148) as endotamponade. Patients experienced extensive retinal vascular occlusion leading to retinal and optic nerve atrophy. The viability of ARPE-19 cells directly exposed to the suspect batch for 30 minutes was 0%. The agarose overlay method used by the manufacturer according to EU regulations and ISO International Standards failed to detect toxicity. FTIR spectroscopy showed small differences between the nontoxic and toxic batches. GC-MS analysis showed the presence of bromotributyl stannane (whose toxicity was demonstrated in the dose response curve) only in the toxic batch of Bio Octane Plus®. CONCLUSION This is the third report of retino-toxicity due to PFO in 4 years. The clinical profiles may be missed, as they resemble other post-surgical complications; therefore, more cases worldwide could have gone unreported. Protocols to determine cytotoxicity of intraocular medical devices and approved by the ISO International Standards based on indirect methods have failed and should be revised to ensure safety.
    Materias Unesco
    3201.09 Oftalmología
    3214 Toxicología
    Palabras Clave
    Experimental – laboratory, Retina, Vision, Visual perception, Treatment other
    ISSN
    0007-1161
    Revisión por pares
    SI
    DOI
    10.1136/bjophthalmol-2017-311471
    Version del Editor
    https://bjo.bmj.com/content/103/1/49.long
    Propietario de los Derechos
    British Medical Association
    Idioma
    spa
    URI
    https://uvadoc.uva.es/handle/10324/68869
    Tipo de versión
    info:eu-repo/semantics/submittedVersion
    Derechos
    openAccess
    Aparece en las colecciones
    • DEP11 - Artículos de revista [242]
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    1.-Coco1_Pastor23 MS27-17 BioctanePlus BJO V6.docx
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    Attribution-NonCommercial-NoDerivatives 4.0 InternacionalLa licencia del ítem se describe como Attribution-NonCommercial-NoDerivatives 4.0 Internacional

    Universidad de Valladolid

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