The overall program objective is demonstration of a new elliptical accommodative intraocular lens (EAIOL), U.S. patent 5,275,623, for implantation in a human eye after cataract extraction. Conventional lenses for this purpose are almost always of fixed optical power for distance, and no commercially available intraocular lens will restore natural lens accommodation (about 4 diopters). In the free state (before implantation), the combined power of the lens system will focus near images onto the retina. Once in the eye, as the zonula attached to the capsular bag are pulled and released by the ciliary muscles, the lenses approach and withdraw from each other to provide focal accommodation. During Phase II, we will test breadboard units in the laboratory, update optical and structural analyses to finalize fabrication (and FDA approval) of animal test units. The animal tests (rabbits, dogs and monkeys) will use prototype units. Upon completion of the animal tests, we will confirm final fabrication plans for subsequent Phase III human test units. We will also confirm material selection for the small-incision design variant, and obtain FDA approvals for that material and device. On the basis of the animal results, we will confirm an experiment protocol and manufacturing plan for Phase III use, for sufficient test units to achieve FDA approval of the lens for cataract surgery use.
An accommodative intraocular lens for cataract replacement surgery could provide significant improvement in postoperative patient vision, and if it performs as predicted, could reach up to 1.5 million units per year in the U.S. for cataract patients alone, with the potential for additional units for presbyopia therapy.
