Compact Adaptive Optics Clinical Prototype for Retinal Imaging

DESCRIPTION provided by applicant Physical Sciences Inc PSI is completing a Phase II program demonstrating a compact research instrument that integrates adaptive optics AO into a line scanning ophthalmoscope LSO The bench top AO LSO instrument significantly reduces the size complexity and cost of research AO scanning laser ophthalmoscopes AOSLO with the goal of transitioning adaptive optics imaging into routine clinical use The PSI AO LSO produces high resolution retinal images with only one moving part and a significantly reduced instrument footprint and number of optical components The AO LSO has a moderate field of view x deg which allows montages of the macula or other targets to be quickly and efficiently obtained An OCT channel also serves as the AO beacon In a preliminary human subjects investigation photoreceptors were resolved and counted to within deg of the fovea Photoreceptor counts closely matched previously reported histology The capillaries surrounding the foveal avascular zone were well resolved including the blood cells flowing within them Individual nerve fiber bundles were resolved especially near the optic nerve head as well as other structures such as the lamina cribrosa In addition to instrument design fabrication and testing software algorithms were developed for automated image registration cone counting and montage stitching The goal of a Phase II B program is technology maturation PSI proposes to continue early stage product development of the clinical prototype to improve performance develop a novel patient interface improve the software user interface develop automated image analysis routines and generate interest and private investment to bring the technology to the market Success in this effort will greatly enhance the likelihood of early FDA regulatory approval Our overall goal is to commercialize a compact AO system at significantly lower cost that bridges the existing gap between high resolution laboratory systems and conventional clinical SLO OCT imaging modalities The AO LSO instrument will be refined and enhanced for clinical operation including an optimized re design of the optical layout for a smaller footprint opto mechanical design of a clinical package modification of scanning hardware and software for automatically acquiring improved macular montages and photoreceptor density maps Several components and subsystems will be upgraded for improved performance and clinical adaptability including pupil tracking and on line point spread function PSF monitoring as an image quality metric A successful Phase II B program and subsequent Phase III commercial development will provide clinicians with high resolution high performance AO imaging at a lower cost and improved functionality superior to other non AO retinal imagers to help guide therapies and improve patient outcome PUBLIC HEALTH RELEVANCE The development of an economical high resolution retinal imager will bring adaptive optics technology into routine clinical use by providing a superior eye imaging tool for early disease diagnosis and treatment Early adaptors of this technology within the research community will increase our understanding of vision and its disruption by disease and will investigate the effects of new drugs and therapies on tissue