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

这个SBIR第一阶段项目将帮助促进多发性硬化症(MS)患者的健康和福利。多发性硬化症是一种使人衰弱的慢性炎症性疾病，在美国有近100万人受到影响。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，该设备可以检测MS疾病活动的变化，使患者和他们的医生能够跟踪治疗反应，并在临床就诊期间检测疾病突发事件。早期发现和适当治疗多发性硬化症对于减少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学和放射学检查来评估疾病活动性和治疗效果的变化。然而，目前还没有办法在这些访问之间实时监控MS。将视网膜病理与大脑中的MS过程联系起来的研究表明，视网膜成像可以提供疾病事件的早期检测，提供了另一种监测途径。因此，这种设备将有助于减少与日益严重的残疾相关的患者医疗成本的增加，并可能影响对患有其他脑部疾病(包括创伤性脑损伤、癫痫和成瘾)的患者的研究和护理。FDA批准后，该设备将出售给多发性硬化症患者、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)来评估与多发性硬化症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，但拟议的设备与当前技术的不同之处在于，它是专门为家庭多发性硬化症患者设计的。这将包括一种坚固的、符合人体工程学的可穿戴设计，适合那些行动不便和其他症状导致难以前往诊所的人。患者将每周短暂使用一次该设备，在此期间，视网膜图像将被自动获取、分析并发送给医生进行远程检查。因此，它将通过使患者更主动地参与他们的疾病管理，进一步增加患者和医生之间的接触。对于这个项目，计划实现以下目标：1)开发该设备的OCT组件，以获取健康组织模体视网膜各层的高分辨率和可重复图像；2)开发设备的FAF组件，以及3)验证该设备？S是否有能力从MS患者和健康人的死后视网膜获取高分辨率和可重复的视网膜层厚度和自发荧光图像。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.