Abstract
A series of recent acute blindness cases following non–complicated retinal detachment surgery caused the release of several health alerts in Spain. The blindness was attributed to certain lots of perfluoro-octane (PFO; a volatile and transient medical device). Similar cases have been reported in other countries. This has raised questions regarding the validity of cytotoxicity test methods currently used to certify the safety of PFO lots. The tests were performed according to the International Organization for Standardization (ISO) norms, using the extract dilution method or the indirect contact method as applied to L929 cells, a line derived from mouse fibroblasts. The limitations of those methods have been resolved in this study by proposing a new cytotoxicity test method for volatile substances. The new method requires direct contact of the tested substance with cells that are similar to those exposed to the substance in the clinical setting. This approach includes a few new technical steps that are crucial for detecting cytotoxicity. Our new method detected toxic PFO lots that corresponded to the lots producing clinical blindness, which previous methods failed to detect. The study suggests applying this new method to avoid occurrence of such cases of blindness.
Highlights
The ARPE-19 cell line, derived from human retinal pigment epithelial cells, is very popular and readily available for research purposes, including toxicity testing. We prepared both types of cultures and exposed them to different PFO samples for 30 minutes, and analysed them at 24 hours by the MTT assay to determine the suitability of each to detect PFO cytotoxicity. Control groups of both cell lines exposed to culture medium alone or to non-toxic PFO sample from other manufacturers and companies and from non-toxic Alamedics PFO lot # 210715 had viabilities >70% and typically they were around 100%
All of the cultures exposed to the culture medium alone or to control non-toxic PFO samples had viabilities at or near 100% at 24 and 72 hours
The results for 60 minutes exposure followed by 24 and 72 hours growth periods showed that the ARPE19 cell culture viability was 25% and 29% for lot # 180214 and 30% and 50% for lot # 080714 respectively
Summary
Control groups of both cell lines exposed to culture medium alone or to non-toxic PFO sample from other manufacturers and companies and from non-toxic Alamedics PFO lot # 210715 had viabilities >70% and typically they were around 100%. Cultures of both cell lines exposed to suspected toxic Alamedics PFO sample lots # 050514 and #061014 had viabilities 70% viability at 72 hours of post-exposure growth.
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