Micro Patterned Intraocular Lens Membrane for Reducing Incidence of PCO

摘要：美国糖尿病患者和老年人的指数增长使这一数字增加了两倍多 在短短20年里做了多少白内障手术。多达一半的手术将导致后路 囊膜混浊(PCO)，需要后续的Nd：YAG激光截囊手术。如果没有这个 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 不能进行囊膜切开术，后囊混浊会导致失明。作为白内障的主要并发症 手术，PCO导致每年仅美国联邦医疗保险系统的成本就高达3.5亿美元。成本是 预计到2050年将超过10亿美元。美国被诊断为糖尿病的人数远远超过了 预测。这组患者的白内障形成率较高，手术后恢复较困难。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，这将 给我们的医疗体系带来越来越大的财务压力。据估计，世界上90%以上的视觉 残疾人生活在发展中国家，后续的激光囊膜切开术在这些国家很少是一种选择 因此，患者由于缺乏资源而遭受视力丧失和/或失明。因此，它是重要的 在全球范围内根除PCO。理想情况下，在最初的白内障摘除后不需要后续手术。 消除后发性白内障的人工晶状体将大大降低与白内障相关的健康风险和成本 手术。PCO是晶状体上皮细胞(LECs)向人工晶状体(IOL)后方迁移的结果。这些 细胞导致晶状体后囊膜混浊，损害视力。Sharklet Technologies提出 继续开发下一代人工晶状体，以防止后发性白内障，并与行业合作伙伴合作 在美国和全球销售这款设备。市场不断地寻求人工晶状体的改进 材料，尤其是在消除导致对比度敏感度降低并导致损失的闪光方面 视觉质量。ClearSight人工晶状体将是第一个通过三个键提供真正清晰视力的人工晶状体 特点：1)外环和膜，保持囊袋膨胀，防止赤道 晶状体上皮细胞沿囊袋后表面迁移，2)鲨鱼纹 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 闪闪发光。我们的第一阶段SBIR研究超过了里程碑，表明在统计上显著降低了 LEC在体外的迁移(减少80%)和在兔体内的PCO(视觉上显著的PCO减少100%)。我们是 我们生产ClearSight人工晶状体和配套注射器的第二阶段项目进展迅速 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人工晶状体人类临床研究的研究设备豁免。第一阶段和第二阶段成功和 我们的专家、多学科团队具有广泛的技术、临床和业务技能，为 成功的商业化项目，以完成试验性临床研究并为我们的设备获得CE标志， 使我们能够进入上市后研究，以支持美国的监管批准。

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.