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

该小型企业创新研究I期项目旨在开发一种新型眼内透镜植入物（IOL），旨在恢复接受白内障手术的患者的全部视觉功能。 目前，在白内障手术期间，将IOL植入用于容纳白内障的囊袋中。这种透镜只在一个距离上提供聚焦视力。所有开发有效的可变焦距（调节性）IOL的尝试都失败了，该项目概念通过具有单独组件的悬韧带捕获支撑襻（ZCH）克服了当前的局限性。 该公司已经在动物模型中建立了概念证明，并表明ZCH与控制眼睛内焦点的睫状体的运动平行。 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设计和完善我们的ZCH原型。该项目的更广泛影响/商业潜力是解决几乎影响每个人的视力退化问题。据估计，到2020年，将有3000万美国人患有白内障，950万人将接受白内障手术。所有的人都会受到老花眼的影响（无法近距离聚焦），如果他们的寿命延长到生命的第四个十年。?溢价？IOL，如Bausch和Lomb？Abbott Medical Optics的Crystalens？ReZoom和Alcon？的ReSTOR仅达到一个屈光度的调节等效，这是不够的。然而，大约7%的白内障患者支付约2,000美元的口袋里每只眼睛超过他们的医疗保险覆盖范围，以获得高级人工晶状体。 高级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类型的手术进行屈光手术，每只眼睛支付2，000 - 6，000美元，以后可能需要白内障手术，并且肯定需要阅读眼镜。如果成功，拟议的ZCH将是恢复IOL运动的唯一技术，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.