SBIR Phase I: A Novel Intraocular Lens using Zonular Capture Haptics

这个小企业创新研究第一阶段项目旨在开发一种新型人工晶状体（IOL），目的是让接受白内障手术的患者恢复完全的视觉功能。目前，在白内障手术中，人工晶状体被植入用于容纳白内障的囊袋中。这种镜片只能在一个距离内聚焦。所有开发有效的可变焦点（可调节）IOL的尝试都失败了，这个项目的概念克服了目前具有单个组件的带状捕获触觉（ZCH）的局限性。该公司已经在动物模型中建立了概念证明，并表明ZCH与控制眼睛聚焦的纤毛体的运动相似。该项目的技术目标是使用ZCH测力计测量眼睛在调节过程中施加的实际力，然后使用这些测量结果来设计和完善我们的ZCH原型。这个项目更广泛的影响/商业潜力是解决影响几乎每个人的视力退化问题。到2020年，估计将有3000万美国人患有白内障，950万人将接受白内障手术。如果寿命超过40岁，所有人都会患上老花眼（无法近距离聚焦）。？保险费?例如鲍许和朗氏人工晶状体？水晶，雅培医疗光学？ReZoom和爱尔康？ReSTOR只能达到一个屈光度的调节等效，这是不够的。然而，约7%的白内障患者为接受高级人工晶状体手术，每只眼睛要比医疗保险覆盖范围多支付约2,000美元。优质iol的全球市场规模约为5亿美元。此外，每年有70万名患者通过lasik手术进行屈光手术，每只眼睛的费用为2000至6000美元，以后可能需要进行白内障手术，并且肯定需要佩戴老花镜。如果成功，ZCH将是唯一一种恢复人工晶状体运动的技术，因此有可能成为矫正白内障、屈光不正和老花眼的成功手术。

This Small Business Innovation Research Phase I project aims to develop a novel intraocular lens implant (IOL) with the goal to restore full visual function in patients undergoing cataract surgery. Currently, during cataract surgery, an IOL is implanted in the capsular bag that used to contain the cataract. This lens provides focused vision at only one distance. All attempts to develop an effective variable focus (accommodating) IOL have failed, and this project concept overcomes the current limitations with a zonular capture haptic (ZCH) that has individual components. The company has established proof of concept in animal models and shown that a ZCH parallels the movement of the ciliary body that controls focus within the eye. The technical goals of this project are to measure the actual forces exerted by the eye during accommodation using a ZCH dynamometer, and then use these measurements to engineer and perfect our ZCH prototypes.The broader impact/commercial potential of this project is addressing the degradation of sight affecting almost every person. By 2020 it is estimated that 30 million Americans will suffer from cataracts and 9.5 million people would have undergone cataract surgery. All human beings are affected by presbyopia (inability to focus up close) if their life span extends past the fourth decade of life. ?Premium? IOLs such as Bausch and Lomb?s Crystalens, Abbott Medical Optics? ReZoom, and Alcon?s ReSTOR only achieve one diopter of accommodation equivalent which is inadequate. Yet about 7% of cataract patients pay about $2,000 out of pocket per eye above their Medicare coverage to receive a Premium IOL. The worldwide market size for Premium IOLs is approximately $500MM. In addition 700,000 patients undergo refractive surgery via Lasik-type procedures each year and pay $2,000-$6,000 per eye with the possibility of later requiring cataract surgery and the certainty of needing reading glasses. If successful, the proposed ZCH would be the sole technology that restores movement to an IOL and as such has the potential of being a successful surgery that corrects cataracts, refractive errors and presbyopia.