A Clinical Trial to evaluate the safety and effectiveness of the RHCIII-MPC biosynthetic cornea in patients requiring deep anterior lamerllar keratoplasty

There is a pronounced deficiency in the world of donor corneas for transplantation. In Western countries the lack of donor corneas is relative but in developing countries there is almost a total absence of availability of donor corneas. Diseases such as trachoma, vitamin A deficiency (xerophthalmia), measles, and bacterial infections are among the leading causes of blindness that can be addressed with corneal transplantation.The choice of material during the 12 years of development has gone from animal collagen to human recombinant collagen, cross-linked with a synthetic molecule composed of recombinant human collagen type III (RHCIII) produced by Fibrogen Inc., USA, by genetic engineering, in yeast. The resulting processed and purified collagen is cross-linked to a carbodiimide, a chemical belonging to the family of water soluble crosslinking agents for fabrication into a hydrated implant or hydro gel. The material has undergone a series of tests with regard to toxicity prior to clinical testing. Nerve regeneration function was demonstrated using in vivo confocal microscopy. The advantage of repopulation of by host keratocytes will improve corneal transparency as the bioengineered cornea will be act more like a “normal†cornea. The implants have been reinforced with a network of phosphorylcholine making them stronger but allowing them to retain all the cell friendly properties and promote regeneration in a range of animal models including mice, guinea pigs, rabbits and mini-pigs. The matrices have been transplanted with a deep lamellar technique during experimentation.The study planned under this protocol will use a reinforced, improved version of the material.