SBIR Phase I: A Novel Intraocular Lens using Zonular Capture Haptics

This Small Business Innovation Research Phase I project aims to develop a novel intraocular lens implant (IOL) with the goal to restore full visual function in patients undergoing cataract surgery. Currently, during cataract surgery, an IOL is implanted in the capsular bag that used to contain the cataract. This lens provides focused vision at only one distance. All attempts to develop an effective variable focus (accommodating) IOL have failed, and this project concept overcomes the current limitations with a zonular capture haptic (ZCH) that has individual components. The company has established proof of concept in animal models and shown that a ZCH parallels the movement of the ciliary body that controls focus within the eye. The technical goals of this project are to measure the actual forces exerted by the eye during accommodation using a ZCH dynamometer, and then use these measurements to engineer and perfect our ZCH prototypes. The broader impact/commercial potential of this project is addressing the degradation of sight affecting almost every person. By 2020 it is estimated that 30 million Americans will suffer from cataracts and 9.5 million people would have undergone cataract surgery. All human beings are affected by presbyopia (inability to focus up close) if their life span extends past the fourth decade of life. ?Premium? IOLs such as Bausch and Lomb?s Crystalens, Abbott Medical Optics? ReZoom, and Alcon?s ReSTOR only achieve one diopter of accommodation equivalent which is inadequate. Yet about 7% of cataract patients pay about $2,000 out of pocket per eye above their Medicare coverage to receive a Premium IOL. The worldwide market size for Premium IOLs is approximately $500MM. In addition 700,000 patients undergo refractive surgery via Lasik-type procedures each year and pay $2,000-$6,000 per eye with the possibility of later requiring cataract surgery and the certainty of needing reading glasses. If successful, the proposed ZCH would be the sole technology that restores movement to an IOL and as such has the potential of being a successful surgery that corrects cataracts, refractive errors and presbyopia.