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A. Staropoli, C. Baudouin, J.–M. Warnet, P. Rat; Problem of Materiovigilance With Intraocular Lens Preloaded in Injector. Role of Conditioning Medium Cytotoxicity . Invest. Ophthalmol. Vis. Sci. 2006;47(13):614.
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© ARVO (1962-2015); The Authors (2016-present)
Following materiovigilance cases encountered with hydrophilic acrylic intraocular lens preloaded in injector, we studied the cytotoxicity of intraocular lens and its conditioning in order to identify the cytotoxic element. We proposed medical device modification in order to improve its biocompatibility.
Biocompatibility–cytotoxicity assays were carried out according to ISO 10993–5 recommendations. Tests were performed on SRA 01/04 human lens epithelial cells line. Neutral red, Hoechst 33342 and YO–PRO–1 fluorescent probes were respectively used to assess membrane integrity, total DNA and membrane fluidity. Materials samples were prepared in culture medium according to elution procedure (ISO 10993–5). Pure saline solutions and conditioning liquids were tested directly on cells.
Intraocular lens and injector biomaterials were not cytotoxic. Conditioning liquids induced membrane fluidity perturbation caracteristic of apoptosis. Tests performed on new versions of the medical device allowed to identify a better adapted conditioning liquid.
Results suggested that the cytotoxicity of the conditioning liquid could explain postoperative complications rate. When we changed the conditionning liquid with sterile irrigating solution, we suppressed cellular stress. Fluorescent probes are well adapted to assess medical device biocompatibility–cytotoxicity.
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