SBIR Phase I:Feasibility of Adjustable Eye Pressure Control within an External Shunt

SBIR 第一阶段：外部分流器内可调节眼压控制的可行性

• 批准号: 1447738
• 负责人: Lucinda Camras
• 金额: $ 15万
• 依托单位: Camras Vision, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1447738&HistoricalAwards=false
• 关键词: SBIR; Phase; Feasibility; Adjustable; Eye

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project allows for a more effective glaucoma treatment by tailoring eye pressure based on disease progression for each patient. In 2015, the US glaucoma market is estimated to be over $2 billion and our addressable market, glaucoma surgical therapies, is estimated to be $534M. The incidence for glaucoma increases with age, and as the baby boomer population gets older, there will be a growing need for glaucoma treatments. To treat the glaucoma, patients will undergo lifelong drug regimens, multiple laser procedures, and invasive surgical procedures. However, even with all these treatment options glaucoma patients still go blind from glaucoma. Our novel design and approach to glaucoma will personalize the treatment for patients and remove the need for numerous and costly procedures. Most importantly, the personalization of glaucoma therapy will optimize visual protection for every patient. The proposed project will demonstrate the feasibility of the first external glaucoma drainage device to adjust and set pressure in the eye. Glaucoma is a leading cause of irreversible blindness and is only treatable by reducing eye pressure. Surgical treatments are unpredictable with suboptimal success rates based primarily on the choice of drainage site. This novel device drains to a new area of the eye to avoid the complications and unpredictability associated with the current glaucoma surgeries. The device also can provide the first-ever personalized treatment for millions of glaucoma suffers by fine-tuning pressure based on the needs of the patient throughout his or her lifetime. Preliminary studies have shown safety and feasibility of the device; however, the customizable and adjustability of replaceable component has yet to be investigated. Therefore, this Phase I research project will test and optimize the replaceable component within the device and determine the risk of biofouling. The ability to set a stable pressure safely, reliably, and predictably would be a major advancement in glaucoma treatment.

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力允许通过根据每位患者的疾病进展定制眼压来更有效地治疗青光眼。2015年，美国青光眼市场估计超过20亿美元，我们的目标市场青光眼手术治疗估计为5.34亿美元。青光眼的发病率随着年龄的增长而增加，随着婴儿潮一代人口的老龄化，对青光眼治疗的需求将不断增长。为了治疗青光眼，患者将接受终身药物治疗，多次激光手术和侵入性手术。然而，即使有所有这些治疗选择，青光眼患者仍然会因青光眼而失明。我们的新设计和青光眼治疗方法将为患者提供个性化治疗，并消除对众多昂贵手术的需求。最重要的是，青光眼治疗的个性化将优化每位患者的视力保护。拟议的项目将证明第一个外部青光眼引流装置的可行性，以调整和设置眼睛中的压力。青光眼是导致不可逆失明的主要原因，只能通过降低眼压来治疗。手术治疗是不可预测的，次优成功率主要取决于引流部位的选择。这种新型装置将水引流到眼睛的新区域，以避免与当前青光眼手术相关的并发症和不可预测性。该设备还可以提供有史以来第一个个性化的治疗数以百万计的青光眼患有微调压力的基础上的需要，病人在他或她的一生。初步研究表明该设备的安全性和可行性;然而，可更换组件的可定制性和可调节性尚未得到研究。因此，该第一阶段研究项目将测试和优化设备内的可更换组件，并确定生物污垢的风险。安全、可靠和可预测地设置稳定压力的能力将是青光眼治疗的重大进步。