Biological Safety Test of Seoultype Keratoprosthesis

ABSTRACT

PURPOSE: To perform biological safety test of the Seoul-type keratoprosthesis (SKpro) according to the international standards. METHODS: Mouse fibroblasts were used to assess the cellular toxicity, and albino rabbits were used for the irritation test, intradermal test, ocular toxicity test, pyrogenic test and transplantation test. Albino guinea pigs were used for the sensitization test, and rats were used for the acute toxicity test and chronic toxicity test. All tests were performed using the SKpro extracts, which was extracted under 121degrees C for 1 hour using a 0.9% normal saline as the solvent. RESULTS: For the cellular toxicity test, all the rat fibroblasts showed cell proliferation inhibition of less than 29%, which proved to be non-cellular toxic. For the irritation test and the intradermal reaction test, none of the albino rabbits showed skin rash, crust or edema. On the ocular irritation test, there were no conjunctival, corneal or iris abnormalities among the albino rabbits. On the sensitization test, none of the guinea pigs showed skin rash, crust or edema. On the acute systemic toxicity test, there were no signs of lethargy or coma among rats. On the pyrogenic test, no temperature increase was observed in the albino rabbits. On the transplantation test, there was no evidence of graft reaction around the cornea. On the chronic toxicity test, complete blood analysis, urinalysis and histological findings 6 month after exposure showed no signs of abnormalities. CONCLUSIONS: The result of this study shows that SKpro is non-toxic and biologically safe.