Diseases of the cornea currently blind ten million people worldwide. Although corneal transplantation is considered to be a successful treatment for corneal blindness, due to a variety of complicating factors less than 100,000 corneal transplants are performed annually. Most of these corneal transplants are performed in the United States and Europe where donor corneas are most readily available. However, even when a donor cornea is available for transplantation, there are still numerous short term and long term complications which may result in poor visual function or even loss of the eye. For this reason, there is a need to develop a good alternative to corneal transplantation. Development of an artificial corneal replacement implant or Keratoprosthesis (Kpro) has been investigated for hundreds of years and has met with some success over the last 50 years. However, based on complicated implantation procedures and material incompatibilities, current KPro implants have limited utility. We have developed novel methods of implantation and designs for a KPro which may help to solve many of the problems of current KPro surgery. In our 6 month Phase I study we intend to implant novel KPros in vivo using an automated corneal pocket making device that we have developed. The novel characteristics of the KPros include: the ability to be injected into an 8 to 9 mm corneal pocket through a 3 to 4 mm incision and a front surface which has been biochemically engineered to allow epithelialization. Specifically, we plan to: Develop and test the ease of use of a soft KPro injector system. II. Determine the quality of implantation and biocompatibility of our novel soft KPro designs using our corneal pocket-making device and implant injector during a four month animal study If our research is successful, it may mean that the majority of patients with corneal disorders that currently require corneal transplantation may be able to receive a new type of artificial cornea instead. This new type of artificial cornea would have the advantages of a quick visual recovery, no need for donor corneal tissue, no risk of donor related disease transmission, and no risk of rejection.
