SBIR Phase I: Presbyopia Correcting Intraocular Lens with a Novel Refractive System for Restoration of a Complete Range of Vision and Spectacle Independence

This SBIR Phase I project aims to address two conditions that are very prevalent in the aging population, presbyopia and cataract, with a single intraocular lens. Presbyopia, the age dependent loss in the ability of the eye to adjust focus, is expected to affect 1.37 billion people worldwide by 2020. Cataract, the irreversible clouding of the lens that results in blurred vision, is expected to affect 30.1 million Americans by 2020. Despite these ever-increasing numbers, there currently is no single product available that restores both visual acuity and a complete range of spectacle-free vision following cataract refractive surgery. Such a solution would provide a greatly improved quality of life for patients and would inform future scientific developments in human accommodation and cataract formation. Alongside improved quality of life, vision correction has the added benefit of increased productivity in the workforce. The cataract surgical and intraocular lens exchange markets are significant, with 25.5 million IOL implants and $3.3 billion in sales in 2016 worldwide. With the growing and aging population, these numbers are expected to increase at a rapid rate. This device will fill a significant unmet need and has the potential of restoring a range of vision unlike any device currently in the market. The proposed intraocular lens utilizes a highly sensitive refractive system leveraging large differences in refractive indices and has a mechanism of action unlike any currently in the market. It has the potential of levels of accommodation that are on par with accommodative abilities in a healthy, natural human lens. Forces in the eye are minimal, so this level of sensitivity is critical to any effective accommodating intraocular lens solution. Current devices and those in development do not exhibit the required level of sensitivity and subsequent accommodative amplitude to warrant significant adoption in the industry. Additionally, the proposed device shape mimics the natural lens, which allows for maximum utilization of the minute forces in the eye and prevents posterior capsular opacification. The first goal of this research will be the design and optimization of the lens utilizing a combination of mechanical and optical modeling. Lens prototypes will then be molded in a biocompatible, medical grade silicone. These prototypes will then be assessed for accommodative ability - first in an established opto-mechanical model eye experiment, then in an established human cadaver eye experiment. Finally, the prototypes will be assessed for injectability, to assure smooth integration with standard cataract surgical procedures. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.