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

这个SBIR第一阶段项目旨在解决在老龄化人口中非常普遍的两种情况，即老花眼和白内障，并使用单一人工晶状体。老花眼是一种与年龄相关的眼睛调节焦点能力的丧失，预计到2020年，全球将有13.7亿人受到影响。白内障是一种导致视力模糊的不可逆转的晶状体混浊现象，预计到2020年，将有3010万美国人受到影响。尽管这些数字在不断增加，但目前还没有一种产品可以恢复白内障屈光手术后的视力和完整的无眼镜视力。这样的解决方案将极大地提高患者的生活质量，并将为人类适应能力和白内障形成方面的未来科学发展提供信息。在改善生活质量的同时，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规模巨大，2016年全球人工晶状体植入物数量为2550万个，销售额为33亿美元。随着人口的增长和老龄化，这些数字预计将快速增长。这种设备将满足一个重要的未得到满足的需求，并具有恢复一系列视力的潜力，不同于目前市场上的任何设备。提出的人工晶状体利用了一个高度敏感的屈光系统，利用了很大的折射率差异，并具有不同于目前市场上任何一种人工晶状体的作用机制。在健康、自然的人类晶状体中，它具有与调节能力相当的调节能力。眼内的作用力很小，因此这种程度的敏感度对于任何有效的可调节人工晶状体解决方案都是至关重要的。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，从而保证在行业中大量采用。此外，建议的装置形状模仿自然晶状体，允许最大限度地利用眼睛中的微小力量，并防止后囊混浊。这项研究的第一个目标将是利用机械和光学建模的组合来设计和优化透镜。镜片原型随后将在生物兼容的医用级硅胶中模塑。然后将评估这些原型的调节能力-首先在已建立的光学机械模型眼实验中，然后在已建立的人身体眼实验中。最后，原型将接受注射评估，以确保与标准白内障手术程序的顺利整合。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.