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

SBIR一期项目旨在解决老龄化人口中非常普遍的两种情况，老花眼和白内障，单人工晶状体。老花眼是一种随年龄增长而导致的眼睛调节焦点能力的丧失，预计到2020年，全球将有13.7亿人受到老花眼的影响。白内障是一种不可逆的晶状体混浊，会导致视力模糊。预计到2020年，白内障将影响3010万美国人。尽管数量不断增加，但目前还没有一种产品可以在白内障屈光手术后恢复视力和完整的无眼镜视力。这种解决方案将大大提高患者的生活质量，并将为人类住宿和白内障形成的未来科学发展提供信息。除了提高生活质量外，视力矫正还有一个额外的好处，那就是提高了劳动力的生产率。白内障手术和人工晶状体交换市场非常重要，2016年全球人工晶状体植入量为2550万，销售额为33亿美元。随着人口的增长和老龄化，这些数字预计将以快速的速度增长。该设备将填补大量未满足的需求，并具有恢复视力范围的潜力，这与目前市场上的任何设备都不一样。所提出的人工晶状体利用高度敏感的折射系统，利用大的折射率差异，并具有不同于目前市场上的任何作用机制。它具有与健康、自然的人类晶状体的调节能力相当的调节水平。在眼睛的力量是最小的，所以这种水平的敏感性是关键的任何有效适应人工晶状体解决方案。目前的设备和正在开发的设备没有表现出所需的灵敏度水平和随后的调节幅度，以保证在工业中得到广泛采用。此外，提出的设备形状模仿自然晶状体，允许最大限度地利用微小的力量在眼睛和防止后囊膜混浊。本研究的第一个目标将是利用机械和光学建模的结合来设计和优化透镜。然后，镜片原型将在生物相容的医疗级硅胶中成型。然后，这些原型将被评估适应能力——首先在一个已建立的光学机械模型眼实验中，然后在一个已建立的人体尸体眼实验中。最后，将评估原型的可注射性，以确保与标准白内障手术程序顺利整合。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.