SBIR-STTR Award

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

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to provide enhanced vision for patients after cataract surgery. Current devices, called intraocular lenses (IOLs), can correct certain vision problems. However, commercially available IOLs do not provide the same restoration of capabilities as other surgeries, such as hip replacements. In particular, current IOLs do not address the problems of presbyopia which is the continual degradation of the ability to change focus from far to near object which eventually results in the need for reading glasses. Devices that attempt to address presbyopia, but fail, represent a $500MM current market. This project has a novel approach to the problem and the opportunity to positively affect the lives of the 3 million people each year that are undergoing cataract surgery.The proposed project will continue to push the bounds of our understanding of the mechanisms of human vision control. Previous work done to measure the forces in the eye used to change vision from near to far objects, will be utilized in the design and testing of an IOL that can truly provide changes in vision like the normal lens of a 30 year old human. Several iterations of design will be tested in a rhesus monkey model to determine the best way to capture the forces in the eye, the optimal design of the shape of the device and materials used, the choice of optic material, and the procedures to insert and activate the IOL. All with the objective to turn currently available forces in the eye into refractive changes in eyesight. The ultimate goal of this project is to have a design that can be used for an FDA application for human clinical trials.