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

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.