Low Cost Device for Detection of Retinal Disease

DESCRIPTION (provided by applicant): The overall goal of the proposed SBIR program is to create a low cost instrument, the Laser Scanning Digital Camera (LSDC), which is a non-mydriatic retinal imaging device for screening diabetic retinopathy with the com bined capability of displaying fixation targets. Diabetic retinopathy is the main cause of visual acuity loss among working age adults in the US, and is increasing worldwide. Diabetic macular edema is most serious when it threatens the fovea, the area that patients use to fixate, and which has the most acute vision. Diabetic retinopathy often remains undetected in underserved populations until symptoms are at a much later stage than just microaneurysms and small hemorrhages. Existing methods of retinal imag ing either have too high a proportion of ungradable retinal images or are too expensive for widespread use. Early detection allows treatment before vision is lost. Aeon Imaging, together with Indiana University, is developing a device that can meet the dem anding requirements of screening in patients with small pupils, darkly pigmented eyes, or moderate cataract, and yet provide a sufficiently wide retinal field for screening. To achieve this ambitious goal, Aeon Imaging will build upon two developments. Fir st, it was recently demonstrated that the lesions in all stages of diabetic retinopathy are readily detectable in high contrast, near infrared images, and without the need for a large pupil. Second, it is possible to produce high contrast images with a low cost, hybrid confocal system with a scanning slit for illumination and a two dimensional solid state array for detection. To demonstrate the feasibility of the proposed device, Aeon Imaging will complete the follow tasks: 1) build a prototype, low cost, r etinal imaging device, the LSDC, and test it with 5 normal subjects, 2) develop an optimal fixation target system to direct the retina to the region of interest and to assess fixation stability in patients with central scotomata and controls, 3) measure re tinal image contrast in patients with mild to moderate diabetic retinopathy and controls, and 4) prepare a detailed system design. These tests will show product feasibility as well as indicate areas that will need additional attention. With this informatio n Aeon Imaging, LLC, will take the technology to Phase II where final product development will be completed and clinical validation studies will be performed for screening for diabetic retinopathy and assessment of where the patient is fixating. This new p roduct will allow more patients to be screened, due to the exceptionally low cost of the device and its potential for use in a wider segment of the population who would normally require pupil dilation. This will reduce health disparities. A final product i s envisioned that will combine anterior and posterior segment imaging in an all-in-one device. It will enable users, including those who are not eye care experts, to work with eye care specialists to locate patients who need treatment or rehabilitation, po tentially expanding from diabetic retinopathy to other diseases. PUBLIC HEALTH RELEVANCE: Aeon Imaging, LLC, will build a novel and extremely low cost Laser Scanning Digital Camera with a 40 degree field of view that will produce high contrast retinal imag es without pupil dilatation or bright lights. Aeon will test its use in diabetic retinopathy screening, for eventual use by a non-expert user and in all patients including minority patients. Fixation targets will help increase the field of view to be scree ned and to assess fixation for low vision rehabilitation.