The SmartlOL(TM) represents a potentially revolutionary technological advancement in the pursuit of restored vision and accommodation for the millions of people with cataracts and presbyopia. Over 2.5 million cataract procedures were performed in the US in 2001 and presbyopia afflicts everyone over the age of 50. A full-size accommodative intraocular lens is formed from a novel shape memory polymer, based on Medennium's SmartPlug(R) technology (US patent 6,234,175). The lens is deformed into a 2.5 mm diameter, 27 mm long rod, cooled and then introduced into the capsular bag through a small incision (3.2 millimeters or less). At body temperature the rod rapidly (in seconds) recovers its original lens shape and optical performance. The design and physical properties are intended to mimic the natural lens and allow the focal point to be changed by accommodative forces within the eye. Prototypes have demonstrated 3 diopters of accommodation in an artificial lens capsule model. Phase I will involve process development, lens characterization, development of implantation techniques, evaluation and optimization of accommodative capability in human cadaver eye models, and initial biocompatibility tests. Optical and mechanical properties will be determined at Medennium and utilized in computer simulations. Prototypes will be evaluated in the human cadaver eyes using mechanical models and optical measurements of accommodation developed by Glasser and Campbell (1998, Vision Research). Consultants will work with cadaver eye models to develop safe and effective surgical techniques for implantation of the SmartIOL(TM). Once the lens design has been advanced to optimize accommodative performance, biocompatibility tests will be started. This work in Phase I will prepare for Phase II testing of an improved design in a primate model and full preclinical studies.
