Micro Patterned Intraocular Lens Membrane for Reducing Incidence of PCO

描述(申请人提供)：美国糖尿病患者和老年人的指数增长使白内障手术在短短20年内至少增加了两倍。其中多达一半的手术将导致后囊混浊(PCO)，这需要使用Nd：YAG激光截囊进行后续手术。如果没有这种额外的手术，患者可能会遭受永久性的视力丧失。在许多国家，激光囊膜切开术是不可用的，后囊混浊会导致失明。后发性白内障是白内障手术的头号并发症，仅在美国医疗保险系统每年就造成2.5亿美元的费用。到2050年，成本将超过10亿美元。除了白内障手术本身，PCO还增加了患者护理和成本负担。在美国，确诊的糖尿病患者的数量远远超过了预测，这一群体经历了高白内障形成率，手术后更难恢复。随着人口老龄化需要更多这样的手术，糖尿病成为一种流行病，成本将显著上升。显然，PCO手术是一个重大的患者护理问题，并正在增加医疗成本。在世界上许多地区，PCO甚至不是一种选择，那里的患者由于缺乏资源而遭受视力丧失。因此，消除对PCO的需要是很重要的。理想情况下，在最初的白内障摘除后不需要后续手术。PCO是晶状体上皮细胞(LECs)附着/迁移到人工晶状体(IOL)后面的结果。这些细胞导致晶状体后囊膜混浊，损害视力，需要随访。 Up激光疗法。消除后发性白内障的人工晶状体将不再需要激光囊膜切开术--极大地降低了相关的风险和成本。理想的装置不会使用可能导致炎症或其他并发症的潜在有害药理物质。Sharklet Technologies Inc.计划开发一种新设备，旨在阻止人工晶状体后面的LEC附着/迁移，并与业界合作，在美国和全球销售该设备。该装置是集成在人工晶状体上的鲨鱼图案膜(PM)。PM由与IOL相同的材料制成，提供了两个关键的支撑元素：一个方形边缘，防止赤道晶状体上皮细胞沿晶状体囊袋后表面迁移，以及鲨鱼图案，进一步阻止晶状体上皮细胞从晶状体囊袋外围附着和迁移到视轴。整个项目的目标是验证、原型和预制造PM/IOL集成装置，在第一阶段验证PM的概念，在第二阶段集成PM/IOL。第一阶段的目标是1)通过体外LEC测试建立概念证明，即Sharklet模式减少了LEC附着和迁移的机制，以及2)验证PM在体内减少了兔眼的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，该项目旨在导致第二阶段的工作，重点是PM/IOL集成原型，适合在统计功率的 第三阶段临床研究之前的动物研究。

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.