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

这个SBIR第一阶段项目开发了一种非侵入性成像技术，以帮助糖尿病视网膜病变(DR)患者挽救视力，DR是美国和世界范围内导致视力丧失的主要原因。美国糖尿病协会估计，DR每年造成980亿美元的生产力损失和医疗费用。DR是I型和II型糖尿病的并发症，会对视网膜敏感的血管系统造成结构性损害。一旦造成结构性破坏，要改善它即使不是不可能，也是困难的。最近的研究表明，视网膜血管系统氧饱和度的微小变化是DR前期和早期的可靠指标--在结构损伤发生之前。由于目前还没有临床上能够达到如此高分辨率的非侵入性技术，因此开发具有临床实用价值的先进的视网膜血氧仪技术是非常必要的。该项目旨在基于一种新的功能成像方法来满足这一主要需求，从而改善美国公民的生活，减少DR的破坏性经济影响。通过减少DR的发生，该项目开发的技术将有助于降低DR治疗的成本及其整体经济负担。该SBIR第一阶段项目开发了一种非侵入性成像技术，可以在一张快照中提供糖尿病患者的高分辨率视网膜氧饱和度图。目前还没有具备这些能力的现有商业技术；拟议中的技术是此类努力中的第一项。与现有方法相比，该项目的成功成果可以成为世界各地眼科医生的商业选择技术，使早期糖尿病视网膜病变或视网膜病变前期的检测具有成本效益。这种非侵入性、瞬时和易于使用的生物光子学技术将有助于糖尿病视网膜病变的诊断和监测。这个项目的范围包括三个部分。首先，实验室规模的研究将验证作为该技术基础提出的创新的、基于物理学的概念和算法。其次，将开发和测试原型。最后，技术原型将在临床环境中进行验证，以确定该技术在实际操作环境中的实用性和有效性。

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.