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

该SBIR II期项目的更广泛/商业影响旨在通过单一器械解决老龄化人群中的两种常见疾病，即老花眼和白内障。老花眼是眼睛调节焦点的能力的年龄依赖性丧失，预计到2020年将影响全球约14亿人。白内障是导致视力模糊的透镜不可逆转的混浊，是世界上失明的主要原因，预计到2020年将影响约3000万美国人。 目前，没有一种产品能在白内障手术后恢复视力清晰度和完整的无障碍视力。 该SBIR二期项目将开发一种新型高灵敏度光学系统的眼内透镜，该系统利用了折射率的巨大差异，并具有新颖的作用机制，可能导致与年轻的老花眼前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矫正幅度来恢复全范围的视力，产生不必要的视觉伪影，或者太复杂而无法大规模采用。使用高灵敏度的光学器件，所提出的装置模仿天然透镜的形状，同时仍然保持相对简单，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外科手术。 与新型眼内透镜相关的技术任务包括：（1）通过器械的屈光范围确保视觉质量，（2）优化力学以恢复完整范围的视觉，（3）与现有外科手术无缝集成，以及（4）测试植入物寿命和安全性。 通过在实验台、尸体和动物模型上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.