SBIR Phase I: Development of a Wearable Retinal Imaging Device for Improved Monitoring of Multiple Sclerosis at Home

该SBIR第一阶段项目将有助于促进多发性硬化症（MS）患者的健康和福利-这是一种使人衰弱的慢性炎症性疾病，影响美国近100万人。将开发一种非侵入性、可穿戴的视网膜成像设备供家庭患者使用，该设备可检测多发性硬化症疾病活动的变化，使患者及其医生能够跟踪治疗反应并检测临床就诊之间的疾病发作。MS的早期发现和适当治疗对于降低疾病进展和残疾的风险至关重要。目前的做法依赖于不频繁的神经和放射学检查，以评估疾病活动和治疗效果的变化。然而，目前没有办法在这些访问之间真实的时间监测MS。将视网膜病理学与大脑中的MS过程相关的研究表明，视网膜成像可以提供疾病事件的早期检测，提供替代的监测途径。因此，该设备将有助于减少与残疾增加相关的患者医疗保健成本的增加，并可能影响视网膜中表现出其他脑部疾病的患者的研究和护理，包括创伤性脑损伤，癫痫和成瘾。FDA批准后，该设备将出售给MS患者，神经学家和研究人员。该项目将产生一种新型视网膜成像设备，使用光学相干断层扫描（OCT）和眼底自发荧光（FAF）来评估与MS进展相关的视网膜生物标志物。虽然OCT和FAF是广泛使用的视网膜成像模式，但所提出的设备与当前技术的区别在于它是专门为MS患者在家中使用而设计的。这将包括一个坚固耐用，符合人体工程学和可穿戴的设计，适合那些谁患有低流动性和其他症状，使前往诊所困难。患者将每周短暂使用该设备一次，在此期间，视网膜图像将自动采集、分析并发送给医生进行远程审查。因此，它将通过使患者更积极地参与疾病管理来进一步增加患者和医生之间的参与。对于本项目，计划实现以下目标：1）开发器械的OCT组件，以采集健康组织模拟体模视网膜中各层的高分辨率和可重复图像，2）开发器械的FAF组件，以及3）验证器械？该奖项反映了NSF的法定使命，并已被认为是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的支持。

This SBIR Phase I project will help advance the health and welfare of individuals with multiple sclerosis (MS) - a debilitating chronic inflammatory disease affecting nearly 1 million people in the United States. A non-invasive, wearable retinal imaging device will be developed for at-home patient use that detects changes in MS disease activity, enabling patients and their physicians to track responses to treatment and detect disease flare-ups between clinical visits. Early detection and proper treatment of MS is crucial to reducing the risk of disease progression and disability. Current practice relies on infrequent neurological and radiological exams to assess changes in disease activity and treatment efficacy. However, there is currently no way to monitor MS in real time between these visits. Research relating retinal pathology to MS processes in the brain demonstrate that retinal imaging can provide early detection of disease events, offering an alternative monitoring pathway. This device will thus help reduce increases in patient healthcare costs associated with increasing disability, and potentially impact the research and care of patients with other brain conditions that manifest in the retina, including traumatic brain injury, epilepsy, and addiction. Following FDA approval, the device will be sold to MS patients, neurologists, and researchers.This project will yield a novel retinal imaging device that uses optical coherence tomography (OCT) and fundus autofluorescence (FAF) to assess retinal biomarkers associated with MS progression. While OCT and FAF are widely-used modalities for imaging the retina, the proposed device differentiates itself from current technologies in that it is specifically designed for use by MS patients at home. This will include a ruggedized, ergonomic, and wearable design suited for those who suffer from low mobility and other symptoms that make trips to a clinic difficult. Patients will use the device briefly once a week, during which time retinal images will be automatically acquired, analyzed, and sent to a physician for remote review. As such, it will further increase engagement between patients and physicians by making patients more proactively involved in their disease management. For this project, the following objectives are planned: 1) Develop the OCT component of the device to acquire high-resolution and repeatable images of layers in a healthy tissue-mimicking phantom retina, 2) Develop the FAF component of the device, and 3) Validate the device?s ability to acquire high-resolution and repeatable images of retinal layer thicknesses and autofluorescence in post-mortem retinas from MS patients and healthy individuals.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.