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

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力是为白内障手术后的患者提供增强视力的服务。目前的人工晶状体（iol）可以矫正某些视力问题。然而，商业上可获得的人工晶状体不能提供与其他手术（如髋关节置换术）相同的恢复能力。特别是，目前的人工晶状体并不能解决老花眼的问题，老花眼是指从远物体到近物体改变焦点的能力不断下降，最终导致需要老花镜。尝试治疗老花眼但失败的设备代表着一个5亿美元的当前市场。这个项目有一个解决问题的新方法，并有机会对每年接受白内障手术的300万人的生活产生积极影响。这个计划将继续推动我们对人类视觉控制机制的理解。以前的工作是测量眼睛中用于从近物体到远物体改变视力的力，将用于设计和测试能够真正提供视力变化的IOL，就像30岁人类的正常晶状体一样。设计的几次迭代将在恒河猴模型中进行测试，以确定捕获眼睛力量的最佳方法，设备形状和使用材料的最佳设计，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现有的力量转化为视力的屈光变化。该项目的最终目标是设计出一种可用于FDA人体临床试验的应用程序。

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.