H content is not predictive of perfluorocarbon ocular endo-tamponades cytotoxicity in vitro
Authors: Ruzza P.; Gatto C.; Ragazzi E.; Romano R. M.; Honisch C.; D’Amato Tóthová J.
ACS Omega Journal: August 2, 2019
doi.org/10.1021/acsomega.9b01793 Online version
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Abstract: In recent years, cases of retinal toxicity occurred in some European, Middle Eastern, and South American countries following the use of perfluorocarbon liquids (PFCLs) on vitreoretinal surgeries owing to impurities in the product. Moreover, Spanish ophthalmologists reported several toxic cases on the use of perfluoro-n-octane Ala Octa (Alamedics, Dornstadt, Germany), raising the necessity of reviewing the current validated methods used for assessing the safety of PFCLs. We proved that in samples of PFCLs contaminated on purpose with impurities previously detected in Ala Octa devices, the determination of the so-called H-content using a 1H NMR quantitative assay implemented with the electronic reference to access in vivo concentrations 2 technology failed to demonstrate a correlation between the H-content and in vitro cytotoxicity test in ARPE-19 and BALB 3T3 cell lines. Therefore, direct information on the safety of PFCLs was provided only by the cytotoxicity test in vitro validated according to ISO 10993-5, and the H-content was not predictive of perfluorocarbon ocular endotamponade cytotoxicity in vitro.
Alchimia is one of the leading European manufacturers of medical devices for ophthalmic surgery and human tissue banking with the aim of improving the daily routine of the medical personnel and the quality of life of patients.