SBIR Phase II: Development of a Lens Replacement Device that Provides Enhanced Visual Acuity.

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是为白内障手术后的患者提供增强的视力。 目前的设备，称为人工晶状体（IOL），可以纠正某些视力问题。 然而，市售IOL不能提供与其他手术（如髋关节置换术）相同的功能恢复。 特别地，目前的IOL没有解决老花眼的问题，老花眼是将焦点从远到近的物体改变的能力的持续退化，这最终导致需要阅读眼镜。 试图解决老花眼但失败的设备代表了5亿美元的当前市场。 该项目为解决这一问题提供了一种新的方法，并有机会积极影响每年接受白内障手术的300万人的生活。该项目将继续推动我们对人类视力控制机制的理解。 先前所做的测量眼睛中用于从近物体到远物体改变视力的力的工作将用于IOL的设计和测试，该IOL能够真正提供像30岁人的正常透镜那样的视力改变。 将在恒河猴模型中对设计的几次迭代进行测试，以确定捕获眼内力的最佳方式、器械形状和所用材料的最佳设计、光学材料的选择以及植入和激活IOL的程序。 所有这些都是为了将眼睛中当前可用的力转化为视力的屈光变化。 该项目的最终目标是有一个设计，可用于FDA申请的人体临床试验。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to provide enhanced vision for patients after cataract surgery. Current devices, called intraocular lenses (IOLs), can correct certain vision problems. However, commercially available IOLs do not provide the same restoration of capabilities as other surgeries, such as hip replacements. In particular, current IOLs do not address the problems of presbyopia which is the continual degradation of the ability to change focus from far to near object which eventually results in the need for reading glasses. Devices that attempt to address presbyopia, but fail, represent a $500MM current market. This project has a novel approach to the problem and the opportunity to positively affect the lives of the 3 million people each year that are undergoing cataract surgery.The proposed project will continue to push the bounds of our understanding of the mechanisms of human vision control. Previous work done to measure the forces in the eye used to change vision from near to far objects, will be utilized in the design and testing of an IOL that can truly provide changes in vision like the normal lens of a 30 year old human. Several iterations of design will be tested in a rhesus monkey model to determine the best way to capture the forces in the eye, the optimal design of the shape of the device and materials used, the choice of optic material, and the procedures to insert and activate the IOL. All with the objective to turn currently available forces in the eye into refractive changes in eyesight. The ultimate goal of this project is to have a design that can be used for an FDA application for human clinical trials.