Portable hand-held non-mydriatic retinal camera

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DESCRIPTION (provided by applicant): The long-term objective of this project is to engineer, test, validate, and commercialize the i-RxCam", a low- priced, portable, and easy to use retinal camera. Because of our Phase I technical accomplishments and demonstrated effectiveness, we can achieve the overarching goal of this Phase II: final verification and validation of the low-priced non-mydriatic retinal camera and repackaging of i-RxCam" for manufacture and commercialization. Our innovative approach for the i-RxCam" is based primarily on a significant departure from current generations of desktop and handheld commercial retinal imaging devices, and those cameras under development. Our design strategy is based on an extensive survey, analysis, and consideration of the user requirements to ensure maximum ergonomic utility. Existing portable retinal imagers, as well as those known to be under development, do not meet the requirements of a low-price camera with sufficient technical capabilities (field of view, image quality, portability, battery power, and ease-of-use) to be distributed widely to the offices of medical practices where trained retinal photographers may not be available. We will achieve the Phase II objectives through two specific aims: 1) to build and assemble two new cameras based on a finalized Phase I prototype camera design, but with minor changes to improve usability and reduce costs; and 2) to re-engineer an advanced prototype that increase the field of view from 32 degrees to 45 degrees. Both cameras will undergo testing in a clinical environment. The metrics for testing will be feedback from imagers on the usability. Percentage of acceptable images for reading will be a second metric. Quantitative metrics, such as resolution, contrast, and dynamic range, will be used as metrics in the bench testing of the devices. In Phase II we will make design changes to improve on the following aspects: larger field of view, smaller pupil access, auto-focus, ergonomics, and portability. We will perform extensive clinical testing in a cohort of N=224 subjects imaged by at least two photographers of differing levels of experience in retinal imaging. The testing and feedback from users will be used to prepare the i-RxCam" for high volume manufacturing, while constraining the cost of goods and manufacture to under $2,000 and maintaining the small footprint and portability requirements. We will conduct the necessary quality and safety studies needed for producing a commercial-ready device that can be submitted for FDA market clearance. The i-RxCam" is a low-priced alternative to expensive retinal cameras, and its development is aligned with the NIH objective to reduce disparities in medical care in rural and underserved populations.