SBIR Phase I: Non-Invasive Retinal Oximetry for Detecting Diabetic Retinopathy prior to Structural Damage

This SBIR Phase I project develops a non-invasive imaging technology to help save the vision of patients with diabetic retinopathy (DR), a leading cause of vision loss in the US and worldwide. The American Diabetes Association estimates that DR causes $98 billion in lost productivity and medical expenses annually. DR is a complication of both type I and II diabetes and results in structural damage to the sensitive vasculature of the retina. Once structural damage is inflicted, it is difficult, if not impossible, to ameliorate it. Recent studies have demonstrated that small changes in the retinal vasculature's oxygen saturation are a reliable indicator of pre-stage and early-stage DR -- before structural damage occurs. Since there is no clinical non-invasive technology capable of achieving such a high resolution, a major need exists for the development of advanced retinal oximetry technologies with demonstrated clinical utility. This project aims to meet this major need based on a novel approach to functional imaging, thereby improving the lives of U.S. citizens and reducing the devastating economic impact of DR. By mitigating its occurrence, the technology developed as a result of this project will help reduce the cost of DR treatment and its overall economic burden. This SBIR Phase I project develops a non-invasive imaging technology to provide high-resolution retinal oxygen saturation maps of diabetic patients in one snapshot. There are no existing commercial technologies with these capabilities; the proposed technology is a first-of-its-kind effort. Compared with existing methods, the successful outcome of this project can become a commercial technology-of-choice for ophthalmologists around the world, enabling cost-effective detection of early stage diabetic retinopathy or pre-retinopathy. This non-invasive, instantaneous and easy-to-use biophotonics technology will aid in both the diagnosis and monitoring of diabetic retinopathy. This project's scope includes three parts. First, bench-scale studies will validate the innovative, physics-based concept and algorithm proposed as the basis of the technology. Second, a prototype will be developed and tested. Finally, the technology prototype will be validated in a clinical setting to establish the utility and effectiveness of the technology in an actual operating environment.