Diabetic Retinopathy (DR), a vision threatening complication of diabetes, can be managed more effectively if detected early. We propose to enable such early diagnosis by developing a portable retinal imaging instrument - LSC EYE - that will, for the first time, extract both the anatomy and physiology of retinal microvasculature t high resolution without the need for dye administration. The LSC EYE is expected to cost less than $2000 and will enable primary care physicians to administer simple, quick and inexpensive retinal exams leading to timely diagnosis of DR. We have developed intellectual property central to the realization of such a device through two innovations: firstly, the extraction of retinal microvessel physiology using laser speckle contract imaging (LSCI) and secondly, the portable implementation of LSCI using a novel imaging sensor in conjunction with a miniaturized optical system. The imaging sensor has been custom designed and fabricated using complementary metal oxide semiconductor (CMOS) technology and performs on par with conventionally used imaging charge coupled device (CCD)cameras with respect to both sensitivity and noise. During Phase I, we will demonstrate the feasibility of achieving a portable retinal imager by incorporating a suite of novel image-enhancing algorithms into the LSCI technique and subsequently validate the safety and efficacy of the LSC EYE in a preclinical rabbit eye model. We will generate the first high resolution LSCI images of the retina capable of resolving blood vessels with diameters less than 60?m. Upon successful completion of Phase I milestones, we will embark on our Phase II efort during which we wil develop a clinical grade portable LSC EYE prototype, apply for investigational device exemption (IDE) and continue to undertake preliminary clinical investigation of the LSC EYE in small number of healthy volunteers and patients with advanced diabetes. ABSTRACT
There is a potential for early diagnosis of diabetic retinopathy through routine enhanced imaging of the retina. The goal of our project is to investigate the feasibility and develop laser contrast speckle imaging for high resolution imaging of retinal anatomy and physiology. We will develop a hand held prototype of a retinal imaging instrument with specifications, as might diagnose diabetic retinopathy early.