Ex vivo test bench for preclinical assessment of intra corneal new medical devices is needed more than ever

Abstract

AbstractPurpose Intra corneal medical devices (ICMD) currently invade the refractive surgery market, particularly for presbyopia. Proposed to correct a simple loss of accommodation and not a disease, they should have very long‐term efficacy and safety objectives. It becomes evident that pre‐clinical tests must be highly efficient in determining the balance of benefits and risks. Despite the European directive 93/42/EEC that defines this balance, several CE marked ICMD, with a quasi‐cosmetic action, are implanted in healthy human corneas after, at best, non‐representative animal experiments. Aim: to demonstrate the urgent need to develop efficient suitable preclinical assessment methods of these ICMDMethods Exhaustive review of the literature about animal models and human experimentations used until now for ICMD assessmentResults None of the usual animal models of ICMD assessment seemed acceptable for various reasons: primate for ethical reasons (presbyopia is not a disease), rat, rabbits and cats for biological reasons especially because of their spontaneous endothelial regeneration, or financial reason especially for long‐term monitoring after implantation in primate, pig, calf or ovines. One ICMD (CE marked since 2005) was tested in 24 rabbits, without any endothelial viability testing, before being implanted in human corneas. Several ICMD (one CE marked since 2009) were never submitted to pre‐clinical assessment and were directly implanted in human corneaConclusion New pre‐clinical assessment, for example ex vivo test bench with very long term stored and monitored human corneas need to be rapidly developed and validated in order to improve patient safety