Micro Patterned Intraocular Lens Membrane for Reducing Incidence of PCO

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至少增加了两倍。这些手术中多达一半会导致后囊膜混浊（PCO），这需要使用Nd：YAG激光囊切开术进行随访手术。如果没有这种额外的手术，患者可能会遭受永久性视力丧失。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。PCO是白内障手术的头号并发症，仅美国医疗保险系统每年的费用就超过2.5亿美元。到2050年，成本将超过10亿美元。PCO增加了患者护理和成本负担，超出了白内障手术本身。美国确诊的糖尿病患者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。随着人口老龄化需要更多的此类手术，糖尿病成为一种流行病，成本将大幅上升。显然，PCO程序是一个重要的病人护理问题，并不断上升的医疗保健成本。PCO在世界上许多地方甚至不是一种选择，患者由于缺乏资源而经历视力丧失。因此，重要的是消除对PCO的需要。理想情况下，初次白内障摘除后不需要进行后续手术。PCO由眼内透镜（IOL）后面的透镜上皮细胞（LEC）附着/迁移引起。这些细胞导致后透镜囊混浊，损害视力，需要随访 激光治疗消除PCO的IOL将消除对激光囊切开术的需要-大大降低相关风险和成本。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。Sharklet Technologies Inc.建议开发一种旨在抑制晶状体上皮细胞附着/迁移到IOL后面的新器械，并与行业合作在美国和全球销售该器械。该器械是集成到IOL上的Sharklet图案膜（PM）。PM由与IOL相同的材料制成，提供了两个关键的支撑元件：防止赤道LEC沿囊袋后表面沿着迁移的方形边缘，以及进一步抑制LEC从囊袋周边附着和迁移到视轴中的Sharklet图案。总体项目目标是验证、原型制作和预制造PM/IOL集成器械，在第I阶段验证PM概念，在第II阶段集成PM/IOL。I期的目标是：1）通过使用LEC进行的体外测试，建立Sharklet模式减少LEC附着和迁移机制的概念验证，以及2）验证PM减少兔眼体内PCO。Sharklet的初步数据和专家，多学科团队为成功的第一阶段概念验证项目奠定了基础，该项目旨在引导第二阶段工作，重点是PM/IOL集成原型，适用于制造前研究和统计动力测试。 在III期临床研究之前进行动物研究。

DESCRIPTION (provided by applicant): The exponential increase of diabetics and the elderly in the U.S. has at least tripled cataract surgeries in just two decades. As many as half of these surgeries will lead to posterior capsular opacification (PCO), which requires follow-up surgery using Nd:YAG laser capsulotomy. Without this additional surgery, patients can suffer permanent vision loss. In many countries laser capsulotomy is not available, and PCO results in blindness. PCO is the number one complication of cataract surgery, and has resulted in > $250 million in annual costs for the U.S. Medicare system alone. Costs will exceed $1 billion by 2050. PCO adds patient care and cost burden beyond the cataract surgery itself. The number of diagnosed diabetics in the U.S. has far out-paced predictions, and this group experiences high rates of cataract formation, with more-difficult recovery from surgery. As the aging population requires more of these surgeries and diabetes becomes an epidemic, costs will escalate significantly. Clearly, PCO procedures are a significant patient care problem and are escalating healthcare costs. PCO is not even an option in many parts of the world, where patients experience vision loss due to lack of resources. It is thus important to eliminate the need for PCO. Ideally, no follow-up surgery would be required after the initial cataract removal. PCO results from attachment/migration of lens epithelial cells (LECs) behind the intraocular lens (IOL). These cells cause the opacification of the posterior lens capsule that impairs vision and requires follow up laser therapy. An IOL that eliminates PCO would eliminate the need for laser capsulotomy-greatly reducing associated risks and costs. The ideal device would not use potentially harmful pharmacologic agents that can result in inflammation or other complications. Sharklet Technologies Inc. proposes to develop a new device designed to inhibit LEC attachment/migration behind the IOL, and to team with industry to market the device in the U.S. and worldwide. The device is a Sharklet-patterned membrane (PM) integrated onto an IOL. Made of the same material as the IOL, the PM provides two critical support elements: a square edge that prevents equatorial LECs from migrating along the posterior surface of the capsular bag, and the Sharklet pattern that further inhibits attachment and migration of LECs from the periphery of the capsular bag into the visual axis. The overall project goal is to validate, prototype, and pre-manufacture the PM/IOL integrated device, with validation of the PM concept in Phase I and integration of the PM/IOL during Phase II. Phase I goals are to 1) establish proof-of-concept that the Sharklet pattern reduces the mechanisms of LEC attachment and migration via in vitro testing with LECs, and 2) validate that the PM reduces PCO in vivo in rabbit eyes. Sharklet's preliminary data and expert, multi-disciplinary team sets the stage for a successful Phase I proof-of- concept project designed to lead to Phase II work focused on PM/IOL integrated prototype suitable for pre- manufacturing studies and testing in a statistically powered animal study prior to clinical studies in Phase III.