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

SBIR 第一阶段：无创视网膜血氧测定法用于在结构损伤之前检测糖尿病视网膜病变

• 批准号: 1647279
• 负责人: Ali Basiri
• 金额: $ 22.5万
• 依托单位: Bioxytech Retina, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-15 至 2018-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1647279&HistoricalAwards=false
• 关键词: SBIR; Phase; Non; Invasive; Retinal

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.

SBIR第一阶段项目开发了一种非侵入性成像技术，以帮助挽救糖尿病视网膜病变（DR）患者的视力，这是美国和全球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，并导致视网膜敏感血管系统的结构损伤。结构性损伤一旦造成，即使不是不可能，也很难改善。最近的研究表明，视网膜血管血氧饱和度的微小变化是DR前期和早期的可靠指标--在结构性损伤发生之前。由于没有能够实现如此高分辨率的临床非侵入性技术，因此主要需要开发具有证明的临床实用性的先进视网膜血氧定量技术。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。作为该项目的成果而开发的技术将有助于降低DR治疗的成本及其总体经济负担。该SBIR第一阶段项目开发了一种非侵入性成像技术，高分辨率视网膜氧饱和度地图的糖尿病患者在一个快照。目前还没有具备这些能力的商业技术;拟议中的技术是首次尝试。与现有方法相比，该项目的成功结果可以成为世界各地眼科医生的商业技术选择，从而能够经济有效地检测早期糖尿病视网膜病变或视网膜病变前期。这种非侵入性，即时和易于使用的生物光子技术将有助于糖尿病视网膜病变的诊断和监测。该项目的范围包括三个部分。首先，实验室规模的研究将验证创新的，基于物理的概念和算法提出的技术基础。第二，将开发和测试原型。最后，将在临床环境中验证技术原型，以确定该技术在实际操作环境中的实用性和有效性。