Preclinical Safety and Efficacy Assessments for Novel Femtosecond Lasers in Corneal Refractive Surgery.

Preclinical safety requirements and test methods have been standardized over time to guide medical device developers in the path needed to manufacture safe devices and achieve regulatory approval. Today, femtosecond lasers are commonly used in cataract and refractive surgeries. Currently, an industry standard to guide developers in preclinical testing of ophthalmic lasers does not exist. Consequently, the data presented in regulatory submissions may vary between manufacturers, making the regulatory review process more ambiguous. Here, the authors present a comprehensive discussion of preclinical test methods applied to the evaluation of an ophthalmic laser. We include in vitro and ex vivo models, as well as an in vivo rabbit model subject to corneal refractive treatments, for consideration in a preclinical safety evaluation plan. Scientific rationale to support the ocular endpoints of evaluation in the rabbit model to demonstrate safety is also presented and discussed.