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

SBIR 第一阶段：采用新型屈光系统的老花眼矫正人工晶状体，可恢复完整的视力范围和眼镜独立性

• 批准号: 1841895
• 负责人: Kevin Harris
• 金额: $ 22.5万
• 依托单位: CLEARSIGHT, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1841895&HistoricalAwards=false
• 关键词: SBIR; Phase; Presbyopia; Correcting; Intraocular

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.

该SBIR I期项目旨在通过单枚人工透镜解决老年人群中非常普遍的两种情况，即老花眼和白内障。老花眼是眼睛调整焦点能力的年龄依赖性丧失，预计到2020年将影响全球13.7亿人。白内障是导致视力模糊的透镜不可逆转的混浊，预计到2020年将影响3010万美国人。尽管这些数字不断增加，目前还没有单一的产品，恢复视力和白内障屈光手术后的一个完整的范围内的无障碍视力。这种解决方案将大大改善患者的生活质量，并将为人类适应和白内障形成方面的未来科学发展提供信息。除了提高生活质量外，视力矫正还可以提高劳动力的生产力。白内障手术和眼内透镜交换市场非常重要，2016年全球有2550万个IOL植入物和33亿美元的销售额。随着人口的增长和老龄化，这些数字预计将迅速增加。该设备将填补一个重大的未满足的需求，并有可能恢复一系列的视力不同于任何设备目前在市场上。所提出的眼内透镜利用高度敏感的折射系统，利用折射率的大差异，并且具有与目前市场上的任何透镜不同的作用机制。它具有与健康、自然的人类透镜的调节能力相当的调节水平的潜力。眼睛中的力是最小的，因此这种灵敏度水平对于任何有效的调节性眼内透镜解决方案都是至关重要的。目前的设备和开发中的设备没有表现出所需的灵敏度水平和随后的衰减幅度，以保证在行业中的大量采用。此外，申报器械形状模仿天然透镜，可最大限度地利用眼睛中的微小力，并防止后囊膜混浊。本研究的第一个目标将是设计和优化的透镜利用机械和光学建模相结合。然后将透镜原型在生物相容的医用级硅胶中模塑。然后将评估这些原型的再现能力-首先在已建立的光学机械模型眼睛实验中，然后在已建立的人尸体眼睛实验中。最后，将对原型进行可注射性评估，以确保与标准白内障手术程序顺利整合。该奖项反映了NSF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。