Portable Retinal Imaging Device for Urgent Referrals and Remote Treatment

DESCRIPTION (provided by applicant): The overall goal of the proposed SBIR program is to implement and evaluate a low cost portable retinal camera, the DLP-Cam, in a community-based system for diabetic retinopathy (DR) screening and treatment. Untreated DRhas reached epidemic levels in underserved populations worldwide. The cost of care, patient awareness and education, and the inadequate availability of community-based disease treatment all contribute to the current disparities in eye care. To fully address this issue, DR screening, followed by vision-saving treatment, must be widely available to the underserved, within the community clinic setting. In response to the ever-growing disparities in eye care, Aeon Imaging proposes a novel retinal imaging device, the DLP-Cam. By combining modern illumination, scanning, and detection technologies, Aeon's DLP- Cam will provide high contrast confocal views of the retina with no dilation, and at a projected production cost considerably below competing products. TheDLP-Cam will be easily detachable from a standard slit-lamp style chin rest and alignment base to transport between sites and to permit handheld retinal imaging by eye care specialists. The DLP-Cam will provide red-free images commonly used in DR screening, as well as near IR and color images. These high contrast images, along with fluorescein angiography (after a patient's ingestion of fluorescein dye) will detect treatable areas of vascular leakage and macular edema to support on- site treatment. Building on Aeon's existing Laser Scanning Digital Camera (LSDC) telemedicine platform, data will be automatically encrypted and uploaded to a secure server for review and referral recommendations. In Phase I, Aeon will build 5 DLP-Cam devices and, in collaboration with UC Berkeley and Indiana University, will perform feasibility testing for DR screening and fluorescein angiography (FA). The DR screening will be conducted by UC Berkeley personnel at the Eastmont Wellness Center community clinic in Alameda County, CA. This community clinic provides county-insured eye care services to the underserved and is already conducting DR screening within the EyePACS telemedicine network, administered by UC Berkeley. Based on ongoing LSDC validation study demographics, 92% of the subject population is expected to be from a racial or ethnic minority, and all will have diagnosed diabetic retinopathy. To assess the potential for oral FA, volunteer patients already undergoing FA in conjunction with retinal disease treatment atIndiana University will be imaged using the DLP-Cam's FA imaging mode. By observing vascular leakage and edema with a portable device, Aeon aims to encourage retinal specialists to deliver treatment with portable lasers or intravitrea injections in the community/multi-specialty clinic setting. At the conclusion of Phase I, Aeon wil have field-tested the DLP-Cam and its low cost screening system, establishing its capability with respect to costlier approaches. If successful, Aeon will be prepared to expandDR screening operations and encourage community clinic disease treatment to help reduce health disparities. PUBLIC HEALTH RELEVANCE: Project Narrative - RFA-EB-11-001 Phase I Aeon Imaging, LLC, will develop a low cost and portable retinal camera,the DLP-Cam, to provide high contrast retinal images without pupil dilatation in patients from diverse racial and ethnic backgrounds. The DLP-Cam will be tested for diabetic retinopathy telemedicine screening, and as a diagnostic device to permit more retinal specialists to deliver a greater range of eye disease treatment in community clinics. If successful, a portable and low cost retinal camera will significantly lower the barriers to eye care among the underserved.