Micro Patterned Intraocular Lens Membrane for Reducing Incidence of PCO

微图案人工晶状体膜可降低 PCO 发生率

• 批准号: 9241166
• 负责人: Kevin Cuevas
• 金额: $ 50万
• 依托单位: CLEARSIGHT, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9241166
• 关键词: Agreement; Aluminum; American; Area; Blindness; Businesses; Capital; Cataract; Cataract Extraction; Cells; Clinical; Clinical Research; Complication; Contrast Sensitivity; Country; Developing Countries; Development; Devices; Diagnosis; Elderly; Enrollment; Ensure; Environmental Wind; Epithelial Cells; Europe; Event; Excision; Eye; Feedback; Formulation; Frustration; General Anesthesia; Goals; Health; Health Care Costs; Healthcare Market; Healthcare Systems; Human; Implant; In Vitro; Incidence; Injectable; Intraocular lens implant device; Investigation; Investments; Laser Surgery; Lasers; Lead; Letters; Licensing; Medical; Medicare; Membrane; Neodymium; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Outcome; Patient Care; Patient risk; Patients; Pattern; Perception; Phase; Physicians; Pilot Projects; Population; Positioning Attribute; Predisposition; Prevention; Procedures; Production; Protocols documentation; Provider; Recovery; Research Design; Resources; Risk; Route; Safety; Small Business Innovation Research Grant; Stress; Structure; Surface; System; Techniques; Technology; Testing; Vision; Vision Disorders; Visual; Visual impairment; Work; Yttrium; base; blind; cell motility; commercialization; cost; design; diabetic; expectation; experience; follow-up; haptics; improved; industry partner; interest; lens; lens capsule; meetings; migration; multidisciplinary; next generation; novel; operation; patient population; post-market; prevent; restoration; skills; success; trend; vitreous floater

Abstract: The exponential increase of diabetics and the elderly in the U.S. has more than tripled the number of cataract surgeries performed in just two decades. As many as half of these surgeries will lead to posterior capsular opacification (PCO), which requires follow-up Nd:YAG laser capsulotomy surgery. Without this additional procedure, patients can suffer permanent vision loss and disability. In many countries laser capsulotomy is not available, and PCO results in blindness. As the primary complication of cataract surgery, PCO results in >$350 million in annual costs for the U.S. Medicare system alone. Costs are expected to exceed $1 billion by 2050. The number of diagnosed diabetics in the U.S. has far out-paced predictions. This group experiences high rates of cataract formation with more difficult recovery from surgery. If current trends continue, as many as one out of three Americans could be diabetic by mid-century, which will place increasing financial stress on our healthcare system. It is estimated that over 90% of the world’s visually impaired are living in developing countries and follow-up laser capsulotomy surgery is rarely an option in these areas; therefore, patients experience vision loss and/or blindness due to lack of resources. It is thus important to eradicate PCO globally. Ideally, no follow-up surgery would be required after the initial cataract removal. An IOL that eliminates PCO would greatly reduce health risks and costs associated with cataract surgeries. PCO results from migration of lens epithelial cells (LECs) behind the intraocular lens (IOL). These cells cause the opacification of the posterior lens capsule that impairs vision. Sharklet Technologies proposes to continue development of a next-generation IOL that will prevent PCO, and to team with an industry partner to market the device in the U.S. and worldwide. The market is continually seeking improvements in IOL materials, especially in elimination of glistenings that cause decreased contrast sensitivity and result in loss of vision quality. This ClearSight IOL will be the first IOL to thus provide truly clear vision via three key features: 1) an outer ring and membrane that maintain capsular bag expansion and prevent equatorial LECs from migrating along the posterior surface of the capsular bag, 2) the Sharklet pattern that further inhibits migration of LECs into the visual axis, and 3) a novel material formulation that is free of glistenings. Our Phase I SBIR studies exceeded milestones, demonstrating statistically significant reduction in LEC migration in vitro (80% reduction) and PCO in rabbits (100% reduction in visually significant PCO). We are making rapid progress in our Phase II project to manufacture ClearSight IOLs and an accompanying injector and validate the safety and efficacy of these designs in anticipation of submitting a regulatory package for an Investigational Device Exemption for human clinical studies on the ClearSight IOL. Phase I and II success and the broad-based technical, clinical, and business skills of our expert, multi-disciplinary team sets the stage for a successful commercialization project to complete pilot clinical studies and obtain a CE Mark for our device, allowing us to move into post-market studies to support regulatory approval in the U.S.

翻译后摘要：糖尿病患者和老年人在美国的指数增长已经超过三倍的数字 在短短二十年内完成的白内障手术。这些手术中有多达一半会导致 晶状体囊混浊（PCO），需要后续Nd：YAG激光晶状体囊切开术。没有这个 额外的手术，患者可能会遭受永久性视力丧失和残疾。在许多国家，激光 晶状体囊切开术不可用，并且PCO导致失明。作为白内障的主要并发症 手术后，PCO仅在美国医疗保险系统中就导致> 3.5亿美元的年度成本。成本 预计到2050年将超过10亿美元。美国确诊糖尿病患者的数量远远超过了 预测。这一群体的白内障形成率很高，手术后恢复更困难。如果 目前的趋势仍在继续，到本世纪中叶，多达三分之一的美国人可能患有糖尿病， 给我们的医疗系统带来越来越大的财政压力。据估计，世界上超过90%的视觉 残疾人生活在发展中国家，这些国家很少选择后续激光晶状体囊切开术 因此，患者由于缺乏资源而经历视力丧失和/或失明。因此重要的是 在全球范围内根除PCO理想情况下，初次白内障摘除后不需要进行后续手术。 消除PCO的IOL将大大降低与白内障相关的健康风险和成本 手术PCO是由透镜上皮细胞（LEC）迁移到眼内透镜（IOL）后引起的。这些 细胞引起损害视力的后透镜囊的混浊。Sharklet Technologies提出 继续开发可预防PCO的下一代IOL，并与行业合作伙伴合作 在美国和全球范围内销售该设备。市场不断寻求IOL的改进 材料，特别是消除引起对比敏感度降低和导致丧失 视觉质量。这款ClearSight IOL将是第一款通过三个关键功能提供真正清晰视力的IOL。 特点：1）外环和膜，保持囊袋扩张，防止赤道 晶状体上皮细胞沿囊袋后表面沿着迁移，2） 进一步抑制晶状体上皮细胞向视轴的迁移，以及3）一种不含色素的新型材料配方 闪光我们的I期SBIR研究超过了里程碑，证明了统计学显著降低， 体外LEC迁移（减少80%）和家兔PCO（视觉显著PCO减少100%）。我们 在我们的第二阶段项目中取得了快速进展，生产ClearSight IOL和配套注射器 并验证这些设计的安全性和有效性，以期提交一份监管方案， ClearSight IOL人体临床研究的试验用器械豁免。第一阶段和第二阶段的成功， 我们的专家，多学科团队的广泛的技术，临床和业务技能为我们提供了一个平台， 成功的商业化项目，以完成试点临床研究，并为我们的设备获得CE认证， 使我们能够进入上市后研究，以支持美国的监管批准。