System for Increasing Patient Access to Eye Exams for Diabetic Retinopathy

Project Summary / Abstract - EY020017 Phase IIB Competitive Renewal The overall goal of the proposed SBIR program is to implement and evaluate a low cost, portable retinal camera, the DLP-Cam, in a primary care system for diabetic retinopathy (DR) screening. Untreated DR has reached epidemic levels in underserved populations worldwide. To fully address this issue, DR screening must lead seamlessly from a patient's primary care provider to vision-saving treatment and must be widely available to the underserved, for instance within a community clinic setting. Aeon Imaging LLC, in partnership with the Indiana University School of Optometry and the UC Berkeley Optometric Eye Center, is addressing the public health challenge of providing eyecare to the underserved by developing cost-effective DR screening cameras and internet-based telemedicine platforms. In Phase II of EY020017, over 1,900 underserved diabetic patients, of which over 90% were racial/ethnic minorities, were imaged at four Alameda County MedicalCenter community clinics using Aeon's Laser Scanning Digital Camera (LSDC), and commercial fundus and OCT cameras for comparison. Images and de-identified imaging session data are transferred for review and analysis to Aeon's cloud server and to EyePACS, aweb-based teleophthalmology platform developed by UC Berkeley and used in over 190 US and international sites. In this Phase IIB Renewal, Aeon seeks to complete the final steps to successfully commercialize its novel DLP-Cam technology for sustainable DRscreening. Aeon's DLP-Cam provides high contrast, confocal views of the retina in natural appearing red/green color images, or monochrome in either red or green, avoiding blue light. No pupil dilation is needed. The compact and lightweight, microprocessorcontrolled, internet ready DLP- Cam is detachable from a standard slit-lamp style alignment base for ease of transport. The projected price is well below competing products. As in EY020017, data will be automatically encrypted and uploaded to secure servers for review and referral recommendations. Clinical validation of the DLP-Cam will be performed by the Joslin Vision Network (JVN), a leading international diabetes research organization. Aeon will also test the integration of the DLP-Cam into the workflow and managed diabetic patient care at 3 primary care sites, where primary care providers (PCPs) will be trained in the evaluation of retinal images. In this DR screening model, referral decisions are communicated at the time of a patient's visit to increase compliance with recommended eye care. Certified telemedicine image graders provide quality assurance of the screening system, and ongoing image feedback for training. The growing disparity in diabetes-related eye care among minority and underserved populations requires a solution such as the DLP-Cam that effectively screens for eye disease, thus assisting PCPs in providing managed care and promoting awareness among diabetic patients. If successful, the DLP-Cam's adoption by PCPs will enable widespread,efficient, and sustainable DR screening, thereby reducing barriers to eye care. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Aeon Imaging, LLC, will field test and clinically validate for diabetic retinopathy screening a low cost and portable retinalcamera that uses novel technology, the DLP-Cam, in both established telemedicine networks and primary care provider practices. The DLP-Cam provides high contrast retinal images without pupil dilatation, important in patients from diverse racial and ethnicbackgrounds. If successful, this portable and low cost retinal camera will significantly lower the barriers to eye care among the underserved.