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

SBIR二期项目的更广泛/商业影响旨在通过单一设备解决老年人口中的两种常见疾病，老花眼和白内障。老花眼是一种随年龄增长而导致的眼睛调节焦点能力丧失的疾病，预计到2020年全球将有大约14亿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，是世界上导致失明的主要原因。预计到2020年，约有3000万美国人将受到白内障的影响。目前还没有一种产品可以恢复白内障手术后的视力清晰度和完整的无眼镜视力。该设备将改变白内障手术的护理标准，提高手术效果。这个SBIR二期项目将开发一种人工晶状体，使用一种新的、高度敏感的光学系统，利用折射率的巨大差异，并具有一种新的作用机制，可能导致与年轻的、前老花个体的能力相当的调节水平。前瞻性技术可能无法表现出足够的适应性幅度来恢复全范围的视觉，产生不需要的视觉伪影，或者过于复杂而无法大规模采用。采用高度敏感的光学器件，该装置模仿自然晶状体的形状，同时保持相对简单，允许最大限度地利用眼睛中的微小力来产生显著的调节，并允许使用标准的白内障手术程序。与新型人工晶状体相关的技术任务包括：(1)通过设备的调节范围确保视觉质量，(2)优化恢复全范围视力的机制，(3)与现有手术程序无缝集成，以及(4)测试植入物的寿命和安全性。通过在台式、尸体和动物模型上的光学和机械测试来验证上述目标，将为临床研究和转化提供坚实的基础。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。

The broader/commercial impact of this SBIR Phase II project aims to address two common conditions in the aging population, presbyopia and cataract, with a single device. Presbyopia, the age dependent loss in the ability of the eye to adjust focus, is expected to affect an estimated 1.4 billion people worldwide by 2020. Cataract, the irreversible clouding of the lens that results in blurred vision and the leading cause of blindness in the world, is expected to affect an estimated 30 million Americans by 2020. Currently no single product restores both visual clarity and a complete range of spectacle-free vision following cataract surgery. The proposed device will change the standard of care for cataract surgery, leading to improved outcomes.This SBIR Phase II project will develop an intraocular lens using a new, highly sensitive optical system that leverages large differences in refractive indices and has a novel mechanism of action, potentially leading to levels of accommodation on par with the abilities of a young, pre-presbyopic individual. Prospective technologies may fail to exhibit adequate accommodative amplitude to restore a full range of vision, produce unwanted visual artifacts, or are too complex for adoption at scale. Using highly sensitive optics, the proposed device mimics the shape of the natural lens while still maintaining relative simplicity, allowing for maximum utilization of the minute forces in the eye to produce significant accommodation and permitting the use of standard cataract surgical procedures. This technical tasks associated with the new intraocular lens include: (1) assuring visual quality through the device’s accommodative range, (2) optimizing mechanics for restoration of a complete range of vision, (3) integrating seamlessly with existing surgical procedures, and (4) testing implant longevity and safety. Validating the objectives above through optical and mechanical testing in benchtop, cadaver, and animal models will provide a strong foundation for clinical investigations and translation.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.