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

这个SBIR第二阶段项目的更广泛的商业影响旨在通过一个单一的设备解决人口老龄化中的两种常见疾病--老花眼和白内障。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，全球将有大约14亿人受到影响。白内障是一种不可逆转的晶状体混浊，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3000万美国人会受到白内障的影响。目前，没有一种单一的产品可以恢复白内障手术后的视觉清晰度和完整的无眼镜视力。这一拟议的装置将改变白内障手术的护理标准，带来更好的结果。这个SBIR第二阶段项目将开发一种人工晶状体，它使用一种新的高度敏感的光学系统，利用巨大的屈光度差异，具有新的作用机制，可能导致调节水平与年轻的老花眼前期个体的能力相当。未来的技术可能无法表现出足够的调节幅度来恢复全范围的视力，产生不需要的视觉伪影，或者太复杂而无法大规模采用。该装置使用高度敏感的光学元件，在保持相对简单的同时模仿自然晶状体的形状，允许最大限度地利用眼睛中的微小力量来产生显著的调节，并允许使用标准的白内障手术程序。这些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)优化机制以恢复完整的视力，(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。通过对桌面、身体和动物模型进行光学和机械测试来验证上述目标，将为临床研究和翻译提供坚实的基础。该奖项反映了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。

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.