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

SBIR 第一阶段：使用小带捕获触觉的新型人工晶状体

• 批准号: 1248141
• 负责人: Paul Beer
• 金额: $ 15万
• 依托单位: Z Lens LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-01 至 2013-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1248141&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Intraocular; Lens

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.

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，人工晶状体被植入用于容纳白内障的囊袋中。该镜片仅在一个距离内提供聚焦视觉。所有开发有效的可变焦（调节）人工晶状体的尝试都失败了，该项目概念通过具有单独组件的小带捕获触觉 (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验证，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来设计和完善我们的 ZCH 原型。该项目更广泛的影响/商业潜力是解决眼睛的退化问题景象几乎影响着每个人。预计到 2020 年，将有 3000 万美国人患有白内障，其中 950 万人将接受白内障手术。如果所有人类的寿命超过四十岁，都会受到老花眼（无法近距离聚焦）的影响。 ？优质的？ IOL，例如 Bausch and Lomb's Crystalens、Abbott Medical Optics？ ReZoom 和爱尔康的 ReSTOR 只能达到 1 屈光度的调节等效值，这是不够的。然而，大约 7% 的白内障患者需要为每只眼睛自掏腰包支付高于 Medicare 保险范围的 2,000 美元才能获得优质 IOL。 优质 IOL 的全球市场规模约为 500MM 美元。 此外，每年有 700,000 名患者通过激光近视手术 (Lasik) 进行屈光手术，每只眼睛支付 2,000 至 6,000 美元，之后可能需要进行白内障手术，并且肯定需要老花镜。如果成功，拟议的 ZCH 将成为唯一恢复 IOL 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。