System for Increasing Patient Access to Eye Exams for Diabetic Retinopathy

DESCRIPTION (provided by applicant): The overall goal of the proposed SBIR program is to implement and evaluate a low cost retinal camera, the Laser Scanning Digital Camera (LSDC), in a system for diabetic retinopathy (DR) screening. Untreated DR has reached epidemic levels in underserved populations worldwide. As the LSDC has already demonstrated its readiness for DR screening in preliminary studies, a Fast-Track proposal is presented. Existing instruments for retinal imaging have been inadequate tools for DR screening as they are too expensive or provide too high a proportion of ungradeable images. Unlike these devices, the patented LSDC design provides a combination of a non-mydriatic design and high contrast retinal images, yet remains low cost and easy to operate. Comfortable near infrared illumination provides strong light return from the retina regardless of eye color. Anterior and posterior segment imaging are real-time. These features allow the LSDC to screen patients with small pupils, darkly pigmented eyes, or moderate cataracts, while providing a sufficiently wide retinal field for analysis. The LSDC will be further developed by Aeon Imaging, using field-testing data and analysis provided by UC Berkeley and Indiana University. Already low cost, LSDC materials and assembly cost savings will be explored further. Apart from low instrument costs, a supporting system that employs trained device operators and graders, including cost-effective and accurate image transfer protocols, is critical for overall DR screening success. Thus, Aeon will partner with an existing clinical communications system, EyePACS, operated by UC Berkeley, that is already providing DR screening and telemedicine referral services to underserved individuals. In Phase I, Aeon, in collaboration with Indiana University, UC Berkeley, and Vision for All, will investigate the performance of the LSDC using trained but non-specialist operators. The initial screening will be feature- based, i.e. the success in detecting specific DR features with the LSDC will be analyzed. The LSDC will be compared against a commercial non-mydriatic fundus camera and a dilated fundus exam. In Phase II, Aeon will incorporate further cost reductions and operator/patient feedback from Phase I studies into the 2nd generation LSDC design. Aeon will also train non-specialist image graders to identify DR features found in LSDC images, and determine whether they can accurately specify which patients require referral for follow-on eye care. A comparative study will determine if screening with the LSDC using trained operators, telemedicine image transfer with EyePACS, and trained image graders matches the independent referral decision made using costlier devices and specialist image analysis. At the conclusion of this study, Aeon will have field-tested the LSDC and the low cost screening system, establishing its capability with respect to costlier approaches. If successful, Aeon will be prepared to expand DR screening operations and help reduce health disparities. PUBLIC HEALTH RELEVANCE: 7. Project Narrative Aeon Imaging, LLC, will further develop a novel and low cost Laser Scanning Digital Camera that has already been shown to produce high contrast retinal images without pupil dilatation in patients from diverse racial and ethnic backgrounds. This retinal imaging device has a sufficiently wide field of view to visualize the optic disc and macula at the same time, and uses comfortable near infrared illumination for real-time imaging. To reduce the overall costs of diabetic retinopathy screening, the success of accurately recommending referral for follow on eye care will be assessed with trained, but non-expert, LSDC operators and image graders.