Abstract
Purpose To introduce the materials, anatomical design, biocompatibility and clinical results of a novel cornea device.
Methods Single piece, fully synthetic, optic-skirt design devices were made from compact perfluoroalkoxy alkane. The skirt and the optic wall were lined with a porous ingrowth surface using expanded polytetrafluoroethylene (ePTFE). Full thickness macroapertures were introduced around the skirt perimeter for nutrition and hydration of the recipient cornea. The material properties of the optic were assessed with regards to Young’s modulus, light transmission, wetting behavior, as well as the bending stiffness of the skirt. Eyedrop penetrance and degradation profile were evaluated. The prototype devices were implanted healthy rabbit model using a minimally invasive intralamellar surgical technique through a 4 mm trephination site.
Results The final prototype has a transparent optic with a diameter of 4.60 mm anteriorly and a skirt diameter of 6.8 mm. The biomechanical and optical properties of the device closely align with the native cornea with an average normalized device skirt bending stiffness of 4.7 kPa·mm4 and light transmission in the visible spectrum ranging between 92-96%. No optical damage to any device was seen in fouling experiments, with only 3 out of 33 device optics having mild superficial debris that could be wiped off. No significant difference was observed in topical drug penetrance in the device implanted eye compared to the naïve eye. The surgery is single-step and does not require a fresh donor cornea. Twelve month clinical and histopathological outcomes in healthy rabbit model showed no extrusion and low rate of infection.
Conclusions This novel synthetic cornea device may offer enhanced tissue integration and reduced inflammation owing to its flexibility and biocompatibility leading to improved retention. Early feasibility human studies are underway.
