A second generation of artificial cornea (Biokpro II).

The properties of a new second-generation colonizable artificial cornea were evaluated in humans. The prosthesis consisted of a peripheral rim of a translucent microporous fluorocarbon polymer (expanded polytetrafluoroethylene) fused with the polymer of the central optic. The optic was made of medical-grade polydimethylsiloxane coated with polyvinylpyrrolidone. Its refractive power was 42.2 diopters and it measured 7.0 mm in diameter and 0.55 mm in thickness. The geometry of the optic was tested by high-frequency ultrasound and intraocular pressure and distensibility were measured in an artificial chamber. Prostheses were implanted in one eye of 13 humans. The average follow-up was 6 months (range 3-9 months). Most of the eyes (11/13) were clinically stable after a 7 months follow up. Seven patients had visual acuity improvements. Mean corrected final visual acuity was 20/200 (range, 20/30 to light perception). Five anatomical failures occured (two extrusions, two retroprosthetic membranes, one endophthalmitis). The new optical core, junction, and surface properties of the polymers offer many advantages, quicker colonization of the supporting skirt, and an optical core with a geometry similar to that of a normal human cornea. Epithelial cells did not migrate over the interface and optical core. It seems that formation of an epithelium over the artificial device is essential for the long-term stability of the implant.