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: 9144823
• 负责人: Kevin Cuevas
• 金额: $ 12.65万
• 依托单位: SHARKLET TECHNOLOGIES, INC.
• 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 2017-05-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9144823
• 关键词: Aluminum; American; Animals; Area; Blindness; Businesses; Capital; Cataract; Cataract Extraction; Cells; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Complication; Country; Data; Developing Countries; Development; Devices; Diagnosis; Elderly; Ensure; Epithelial Cells; Europe; Excision; Eye; Feedback; Goals; Health; Health Care Costs; Healthcare Systems; Human; Implant; In Vitro; Incidence; Inflammation; Intraocular lens implant device; Laser Surgery; Lasers; Lead; Letters; Life; Manufacturer Name; Marketing; Medical; Medicare; Membrane; Microscopic; Modeling; Modification; Neodymium; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Outcome; Patient Care; Patients; Pattern; Phase; Phase II Clinical Trials; Population; Predisposition; Prevention; Procedures; Production; Recovery; Regulation; Research Design; Resources; Risk; Safety; Small Business Innovation Research Grant; Staging; Stress; Surface; System; Techniques; Technology; Test Result; Testing; Validation; Vision; Vision Disorders; Visual; Visual impairment; Work; Yttrium; base; cell motility; commercialization; cost; design; diabetic; experience; follow-up; haptics; improved; industry partner; lens; lens capsule; meetings; migration; next generation; novel; operation; patient population; performance tests; phase 1 study; prevent; research clinical testing; restoration; skills; success; trend; yttria

 DESCRIPTION (provided by applicant): 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 >$280 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. The ideal device would not use potentially harmful pharmacologic agents that can result in inflammation or other complications. 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. This membrane-protected IOL, the ClearSight IOL, will be modified with the Sharklet pattern on the area surrounding the optic. The ClearSight IOL provides two key features: 1) a dual square edge that maintains capsular bag expansion and prevents equatorial LECs from migrating along the posterior surface of the capsular bag, and 2) the Sharklet pattern that further inhibits migration of LECs into the visual axis. 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). Phase II goals are to manufacture ClearSight IOLs and an accompanying injector, validate the safety and efficacy of these designs, and submit a regulatory package for an Investigational Device Exemption for human clinical studies on the ClearSight IOL by the end of Phase II. Phase I success and the broad-based technical and business skills of its expert, multi-disciplinary team sets the stage for a successful Phase II manufacturing and validation project designed to lead to post- Phase II clinical trials in collaboration with a third-party investor or industry partner.

 描述（由申请人提供）：美国糖尿病患者和老年人的指数增长在短短二十年内使白内障手术的数量增加了两倍多。这些手术中多达一半会导致后囊膜混浊（PCO），这需要后续Nd：YAG激光囊切开术。如果没有这种额外的程序，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是不可用的，并且PCO导致失明。作为白内障手术的主要并发症，PCO仅在美国医疗保险系统中就导致> 2.8亿美元的年度成本。预计到2050年，成本将超过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。如果目前的趋势继续下去，到本世纪中叶，多达三分之一的美国人可能患有糖尿病，这将给我们的医疗保健系统带来越来越大的财政压力。据估计，世界上超过90%的视力受损者生活在发展中国家，在这些地区，后续激光囊切开术手术很少是一种选择;因此，患者由于缺乏资源而出现视力丧失和/或失明。因此，在全球范围内根除PCO非常重要。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手术相关的健康风险和成本。理想的器械不会使用可能导致炎症或其他并发症的潜在有害药物。PCO是由透镜上皮细胞（LEC）迁移到眼内透镜（IOL）后引起的。这些细胞导致后透镜囊混浊，损害视力。Sharklet Technologies提议继续开发可预防PCO的下一代人工晶状体，并与行业合作伙伴合作在美国和全球范围内销售该设备。这种膜保护IOL，即ClearSight IOL，将在光学部周围区域使用Sharklet图案进行改良。ClearSight IOL具有两个关键特征：1）双重方形边缘，可保持囊袋扩张并防止赤道部LEC沿囊袋后表面沿着迁移，以及2）Sharklet图案，可进一步抑制LEC迁移至视轴。我们的I期SBIR研究超过了里程碑，证明了体外LEC迁移（减少80%）和兔PCO（视觉显著PCO减少100%）的统计学显著性降低。II期的目标是生产ClearSight IOL和随附的注射器，确认这些设计的安全性和有效性，并在II期结束前提交ClearSight IOL人体临床研究的试验用器械豁免的监管包。第一阶段的成功及其专家，多学科团队的广泛技术和业务技能为成功的第二阶段制造和验证项目奠定了基础，该项目旨在与第三方投资者或行业合作伙伴合作进行第二阶段后临床试验。