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: 8453301
• 负责人: Kevin Cuevas
• 金额: $ 20.26万
• 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 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8453301
• 关键词: Address; Aluminum; Animals; Biological Assay; Blindness; Capital; Cataract; Cataract Extraction; Cell-Matrix Junction; Cells; Clinical Research; Complication; Country; Data; Device Designs; Devices; Diabetes Mellitus; Diagnosis; Elderly; Elements; Endothelial Cells; Epidemic; Epithelial Cell Proliferation; Epithelial Cells; Excision; Eye; Goals; Health Care Costs; Human; Immigration; Impairment; Implant; In Vitro; Incidence; Industry; Inflammation; Intraocular Lens Implantation; Intraocular lens implant device; Laser Surgery; Lasers; Lead; Lens (device); Letters; Low-Level Laser Therapy; Manufacturer Name; Marketing; Medical; Medicare; Membrane; Methods; Metric; Microscopic; Modeling; Neodymium; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Pathogenesis; Patient Care; Patients; Pattern; Phase; Population; Predisposition; Procedures; Publishing; Recovery; Relative (related person); Research; Resources; Risk; Small Business Innovation Research Grant; Solutions; Staging; Surface; System; Techniques; Technology; Testing; Text; Tissues; Validation; Vision; Visual; Visual impairment; Work; Yttrium; aging population; base; cell motility; clinically relevant; commercialization; cost; design; diabetic; experience; follow-up; improved; in vitro testing; in vivo; industry partner; innovation; lens; lens capsule; migration; next generation; novel; operation; patient population; prevent; prototype; public health relevance; safety study; success; yttria

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.

描述（由申请人提供）：在美国，糖尿病患者和老年人呈指数增长，在短短二十年里，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），这需要后续手术使用Nd:YAG激光囊切开术。如果不进行这种额外的手术，患者可能会遭受永久性视力丧失。在许多国家，激光囊膜切开术是不可用的，PCO导致失明。后发性白内障是白内障手术的第一大并发症，仅美国医疗保险系统每年的费用就高达2.5亿美元。到2050年，成本将超过10亿美元。PCO增加了白内障手术本身的病人护理和费用负担。在美国，被诊断为糖尿病的人数远远超过了预期，这一群体的白内障形成率很高，手术后恢复更加困难。随着人口老龄化需要更多的此类手术，以及糖尿病成为一种流行病，成本将大幅上升。显然，PCO程序是一个重要的患者护理问题，并且正在增加医疗保健费用。在世界上许多地方，PCO甚至不是一种选择，那里的患者由于缺乏资源而出现视力丧失。因此，消除PCO的必要性是很重要的。理想情况下，初次白内障摘除后不需要进行后续手术。PCO是由人工晶状体（IOL）后晶状体上皮细胞（LECs）附着/迁移引起的。这些细胞导致晶状体后囊混浊，损害视力，需要跟随