Nachsicht Report

In order to ensure the safety of users of the Nachsicht device, it will go through a series of rigorous testing to assess its biocompatibility and ability to be sterilized. As the materials used in the Nachsicht, polymethyl-methacrylate (PMMA) and graphene, have been used in other biomedical applications, the host response to the device is highly predictable. Various options for sterilizing the device will be assessed. The tests will be performed in vitro and in vivo before proceeding to clinical trials in order to submit for and gain FDA approval.
In order to assure the quality of a device intended for surgical implementation, it must be sterilized—that is, deficient of all living microorganisms—using the most effective methods. While …show more content…
The animal model that best answers all of the concerns related to biocompatibility is the rhesus monkey. In order to perform six tests, six monkeys will be used in the six-month study. Each monkey will have a Nachsicht device implanted in one eye according to the procedures intended for humans. The size of the device will need to be adjusted for the difference in sizes of the primate eyes and human eyes. During the six-month time period, the monkeys will be monitored and housed in accordance with the Animal Welfare Act. Monitoring will include inflammation, neovascularization, corneal edema, and any other noticeable abnormalities. At the close of the follow-up period, the eyes containing the implant will be enucleated. These eyes will be immediately fixated in formalin to preserve the tissue of the eyeball. They will then be sectioned equally to examine the internal effects of the Nachsicht on the ocular tissues. Any and all observations will be noted and captured digitally with photographs. An ophthalmic pathologist will perform histopathological evaluations on the posterior and anterior sections. The device itself will be examined for structural integrity and any atypical cell growth or any sign of fibrous