According to the National Institutes of Health, there are more than 80 million people in the US who suffer from a potentially sight-threatening disease. Doctors see seven to eight million new cases of eye disease annually. More than two million Americans age 50 and older have advanced AMD, the stage that can lead to severe vision impairment and 10 million have early or intermediate AMD. Glaucoma affects more than 2.3 million Americans age 40 and older. Another two million individuals with glaucoma are undiagnosed. Diabetes cases in the US and throughout the world have been on the rise. Poor eating habits and lack of exercise, factors which contribute to type 2 diabetes, have led to an increasingly overweight population. According to the International Diabetes Federation, there are 285 million cases of diabetes in the world as of 2010. For the type 2 diabetics, 50% will develop diabetic retinopathy within 15 years of disease diagnosis. Regular eye disease screening is necessary to prevent the progression of eye diseases to advanced, sight-threatening stages. The objective of this project is to develop and test a low-cost, hand-held, non-mydriatic retinal camera for widespread applications, including teleretinal screening for eye diseases such as diabetic retinopathy, glaucoma, and age-related ocular diseases. The proposed camera fills an important unmet need: low-cost (under $1,500 cost of goods);small footprint (principally a hand-held device);and easy to use (ergonomically designed for operation by a minimally trained medical technician or nurse). Introducing this technology to a clinic environment will allow underserved individuals to receive regular eye screenings without traveling to an eye care professional. To meet this goal, our proposal has two aims. First, we will produce a prototype of the low-cost, hand-held, non-mydriatic camera, which will be based on an early prototype of a mydriatic camera that was developed, and for which early testing has shown significant functionality. The design is based on low-cost, off-the-shelf components that can be assembled easily for a high- volume market. Second, we will test this camera in a screening or clinic environment. Making the camera ergonomically suitable for use by a minimally trained individual will be the goal of this aim. Quantitative analysis will be performed as to field of view, resolution, and safety.
Retinal screening for diseases such as diabetic retinopathy is performed currently with specialized cameras that cost approximately $20,000. For small medical practices and clinics, especially those in underserved areas who are most in need of screening technology, this cost is prohibitive. In this project, we will develop a non-mydriatic, low-cost, hand-held camera that could be sold for $5,000 as a component of a telemedicine-based eye disease screening system.