The soft keratoprosthesis.

PURPOSE: The purpose of this work was to develop a keratoprosthesis which utilizes a biocolonizable skirt attached to a soft, elastomeric optic for world-wide application.
METHODS: Over a period of 20 years, using in vivo animal implantation studies, a series of experiments was conducted testing materials for biocompatibility and durability which resulted in the development of an improved design. A new surgical technique was developed, using porous, biocolonizable haptics embedded within the sclera and combined with the established techniques of resection of Descemet's membrane and a conjunctival flap.
RESULTS: Animal implantation studies indicated that 6 haptics, equidistantly placed, was the optimal shape. Two clinical trials resulted in the selection of an aliphatic polyether-based urethane for the optic and 60 mu pore polytetrafluoroethylene for the porous ingrowth material. Heated, pressurized injection moulding proved to be the optimal bonding method between the skirt and the optic. Sclerally embedded haptics achieved excellent integration with the tissue.
CONCLUSIONS: This keratoprosthesis is a significant improvement over previous models with a rigid optic in that: 1. The porous ingrowth haptic is sclerally anchored, preventing extrusion. 2. It has a soft elastomeric optic which more successfully defuses the shearing forces of the keratoprosthesis/tissue interface secondary to blinking. 3. The optic is less massive and of greater circumference at the optic/tissue interface, thereby imparting less energy per area with a given movement. 4. The optic does not project posteriorly thereby decreasing anterior chamber irritation and reducing the possibility of glaucoma, uveitis, endophthalmitis, and retinal detachment. 5. This keratoprosthesis allows a normal field of view for the patient and an effective funduscopic view for the surgeon. 6. The large optical diameter eliminates problems with decentralization of the image. 7. It has a significantly better cosmetic appearance.