SBIR/STTR Award attributes
Project Summary/AbstractThere is currently a significant need for new imaging techniques that may enable accurate quantification of biomarkers for detection, diagnosis, and monitoring of retinal diseases progression. Physical Sciences Inc. (PSI), Massachusetts Eye and Ear (MEE), and Joslin Diabetes Center (JDC) propose to develop a clinical tool able to routinely image retinal ganglion cells (RGCs) and to characterize microglia spatial distribution and temporal dynamics in live human eyes using a label-free adaptive optics (AO) imaging approach for improved diagnosis and treatment of glaucoma and diabetic retinopathy (DR). An ultra-high speed AO-OCT system will be designed and built based on a number of recently demonstrated innovations: lens-based design, ultra-high speed to eliminate motion artifacts, buffered swept source (SS) and dual beam approach to increase A-line rate to the MHz range, adaptive lens, dual-axis MEMS for raster scanning, and the use of polarization optics to eliminate specular reflections on optical elements. The retinal imager will be tested in a clinical setting at MEE and JDC on a large group of glaucoma and DR subjects experiencing a wide range of disease severity. Specific biomarkers for glaucoma and DR will be defined based on patient data acquired by our collaborators from MEE and JDC.PSI has a long, successful history of developing and commercializing high-resolution retinal imagers for the ophthalmic research market which gives us a competitive advantage in developing and maturing this platform that enables routine clinical imaging of human subjects and motivates a Direct to Phase II approach. A successful program and subsequent Phase III commercial development will provide clinicians with high performance retinal imaging for glaucoma and DR investigations at a lower cost and improved functionality superior to other non-AO retinal imagers. Early adaptors of this technology within the research community will grow our understanding of vision and its disruption by glaucoma and DR and will investigate the effects of new drugs and therapies. The ability to visualize ganglion and macrophage cells without fluorescent labeling in the human eye represents an important advance for both ophthalmology and neuroscience, which will lead to identification of novel disease biomarkers and new avenues of exploration in disease progression.