A Novel Artificial Cornea Implantation In Primates And Human

To evaluate the efficacy and biocompatability of a novel artificial cornea in animal
and human.

Preclinical aminal study and phase 3 human study in a university hospital setting 

A novel disc type artificial corneas consisting of a new PMMA polymer central optic part (dia 6mm) and porous skirt (2mm), which was a similar to Alphacor shape, were implanted in 20 rabbits, 3 primates and 4 humans. The 300 degree corneal peritomy was made and corneal flap was made. After removal of the central posterior cornea (dia 3 mm), the artificial cornea was inserted. and a flap was sutured to the original postion. The central visual axis was obtained with trephine 2 weeks later. Photos were taken and histological analysis was performed to confirm the biocompatibility of the skirt and the degree of cell proliferation with surrounding tissues.

Rabbits were follow-up 3 months. Thirteen of 20 rabbits were found to maintain the light permeability of the core until 12 weeks after the surgery (65% success rate). Although suture release and conjunctival tissue adhesion was found each rabbit, they were maintained without failure or ocular inflammation until 12 weeks after the surgery. Artificial corneas was exposed and protruded in 7 rabbit. Primates were follow-up 6 months. Artificial corneas remained without extrusion upto 42 weeks (100% success rate). In one patient, In humans, in one patient, it was maintained well during the 6-month observation period, in 2 patients, it was maintained well until the 2-month observation period, and in one patient it was extruded after 3 months.

Considering the results in primates and humans, there seems to be possibility for human 
usage. However, it needs further study.