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.

Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model.

Introduction: To establish the preclinical safety and equivalency of ophthalmic viscosurgical devices (OVDs) comprised of bacterially sourced sodium hyaluronate (HA) to animal sourced HA using pyrogenicity and aqueous exchange models in rabbits and a novel mini-pig model to evaluate corneal endothelial cell protection in vivo.

Methods: HEALON OVD and HEALON5 OVD containing animal-derived HA and HEALON PRO OVD and HEALON5 PRO OVD containing bacterial-derived HA were used. Two rabbit aqueous exchange studies were conducted where aqueous humor was exchanged with OVDs in six animals each to observe potential ocular inflammation, intraocular pressure (IOP) response, corneal health and pachymetry until 7 days post procedure, as well as overall assessment of the OVDs.