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Nécessite d'une approche analytique confondante dans l'évaluation des dispositifs médicaux implantables en biopolymères : application aux lentilles intraoculaires à base de polyacrylates.

Abstract : Intraocular lenses are the main treatment for cataract surgery whatever the origin. The implantation is done in the same surgical time as the lens extraction by phacoemulsification. Today, the recommended lenses are foldable acrylic copolymers with square edges and “1-piece”. This design decreases the incidence of adverse events as posterior capsular opacification (POC). This complication is multifactorial and is associated with a poor biocompatibility. The surgery and physiopathology are two others factor that impact the incidence of PCO. Despite many preventive actions, the incidence is not null and prevalence keep on increasing each year after the surgery. The late PCO cases occur until 9 years after the surgery. One of our objectives in the context of this work was to link this late complication to the aging mechanism of intraocular implants. The results obtained after hydrolysis and photo-oxidation have showed the characteristic modifications of the polymer with formation of low molecular weight compounds, which diffuse through the polymer and migrate to the surface, as a function of their polarity and their molecular weight. All these modifications have created concentration gradient. Indeed, the hydrophilic compounds have diffused on the surface and hydrophobic compounds in the implant matrix. The kinetic of the aging process is directly related to the aging conditions applied (temperature, intensity of photo-oxidation). Furthermore, we have demonstrated the existence of the variability between and within batches, of the physicochemical characteristics of these implants. These surface property modifications are an explanation for the occurrence of late complications that is related to a modification of the intraocular lenses biocompatibility after aging.
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Lionel Tortolano. Nécessite d'une approche analytique confondante dans l'évaluation des dispositifs médicaux implantables en biopolymères : application aux lentilles intraoculaires à base de polyacrylates.. Sciences pharmaceutiques. Université Paris Saclay (COmUE), 2016. Français. ⟨NNT : 2016SACLS121⟩. ⟨tel-01968038⟩

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