SBIR Phase I: Feasibility of a Wearable Blindness Prevention System

该小型企业创新研究第一阶段项目包括开发一种可穿戴系统，该系统能够通过持续监测眼内压（IOP）来准确跟踪青光眼进展。青光眼是世界上不可逆失明的主要原因，影响全球近8000万人。使用一种新型的可穿戴系统，验光师，眼科医生和多个学科的医疗专业人员可以在就诊时查看IOP趋势，实时监测高风险患者，并编程患者特定的阈值警报，以防止青光眼和相关疾病引起的不可逆失明。通过成功的产品商业化，新型可穿戴防盲系统（BPS）预计每年将被约200万青光眼患者采用。该器械的用户可持续访问IOP数据趋势。当有风险的患者未能遵守规定的每日药物治疗（由于IOP水平过高）时，临床医生将收到警报，并可持续跟踪规定的降IOP治疗的疗效。最后，该系统的IOP跟踪能力将提高普通临床医生、医学专家和临床研究人员的护理质量，并将成为当前向数据驱动的方向发展的主要参与者，该项目的智力价值集中在实验室可行性测试的基本概念背后的新型防盲系统技术-基于图像的压力传感-在台式3D打印青光眼模拟器上，使用该系统的alpha原型进行监测。 该研究计划包括测试互补金属氧化物半导体（CMOS）相机的可行性，该相机可以安装在一对镜框内，加上处理器，光学器件和软件，作为在台式环境中记录眼组织压力变化的一种方式。其主要目标是使用与标准移动终端通信的alpha原型a-BPS，在模拟器中准确检测不健康的眼压水平，并具有高重复性。 a-BPS的目标研究结果是，每当模拟器中的眼压超过临床相关阈值时，以可重复的方式成功触发高压警报。预计第一阶段的研究结果将在90%或更多的测试样品中成功运行。第一阶段的成果将被用作第二阶段原型的设计输入，该原型将是可穿戴的，并将允许在人体上进行测试。该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估来支持。

This Small Business Innovation Research Phase I project comprises the development of a wearable system capable of accurately tracking glaucoma progression via continuous monitoring of intraocular pressure (IOP). Glaucoma is the leading cause of irreversible blindness in the world and affects nearly 80 million people worldwide. Using a novel wearable system, optometrists, ophthalmologists, and medical professionals across multiple disciplines can review the IOP trends at visits, monitor high-risk patients in real-time, and program patient-specific threshold alarms that will prevent irreversible blindness caused by glaucoma and related conditions. Through successful product commercialization, the novel wearable blindness prevention system (BPS) is expected to be adopted by approximately 2 million glaucoma patients annually. Users of the device will have continuous access to IOP data trends. Clinicians will be alerted when at-risk patients fail to comply with prescribed daily medicinal treatment (due to excessive IOP levels) and can continuously track the efficacy of prescribed IOP-lowering treatments. Finally, the IOP tracking capability of the system will allow improvements in the quality of care for general clinicians, medical specialists, and clinical researchers and will be a major player in the current move toward data-driven, value care.The intellectual merit of this project centers on laboratory feasibility testing of the fundamental concept behind the novel blindness prevention system technology - image-based pressure sensing - on a benchtop 3D-printed glaucoma simulator that is monitored using an alpha prototype of the system. The research plan includes testing of the feasibility of a complementary metal oxide semiconductor (CMOS) camera which fits inside a pair of eyeglass frames, plus processor, optics, and software, as a way to record pressure changes in eye tissue in a benchtop environment. The key objective is to accurately - and with high repeatability - detect unhealthy eye pressure levels in the simulator using an alpha prototype, a-BPS, that communicates with a standard mobile device. The target research outcome for the a-BPS is to successfully trigger a high-pressure alarm in a repeatable manner whenever eye pressure in the simulator exceeds a clinically-relevant threshold. It is anticipated that the Phase I research results will show successfully operation in 90% or more of the test samples. The output from the Phase I effort will be used as design inputs for a Phase II prototype, which will be wearable and will allow testing on humans.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.