This SBIR project seeks to develop a low-cost home vision self-test system which

描述（由申请人提供）：在过去的十年中，已经开发了针对糖尿病视网膜病变（DR）的有效疗法，但是太多处于发展糖尿病视网膜病变的更晚期阶段的高风险的糖尿病患者甚至无法获得由AAO、ADA和AMA推荐的年度眼科检查，并且许多人因此遭受可预防的视力丧失。RFA-EY-09-001的一个主要目标-创新的患者外展计划和眼部筛查技术，以改善糖尿病视网膜病变的检测-是“开发工具和系统，用于增加患者获得眼科检查，以检测DR。“重要的艺术和科学公司（VAS）是由一个多学科的研究人员和商业人士小组成立，专门解决这一差距，创造一个工具，可以放在病人的手中。VAS的目标是验证并商业化一种低于100美元的家庭视力自检设备，医疗保健提供者可以向患者提供更频繁和方便的筛查，以检测关键的糖尿病视网膜病变状态变化。 第一阶段SBIR项目是一个“概念测试”的原型视力自我测试设备，VAS已开发用于在家庭中跟踪眼睛疾病的进展。其目的是评估糖尿病患者有效使用该设备的能力和意愿，以及其在确定何时需要立即护理方面的有效性。我们将招募40名已经被诊断患有糖尿病视网膜病变的患者，参加为期8个月的临床方案，要求每周在家中使用我们的原型系统进行自我测试，并计划在办公室进行全视力检查（基线，4个月，8个月），包括功能性视力测试和视网膜成像分析。将临床结果与自测结果进行比较，以检验以下假设：1）患者愿意并能够每周在家进行视力自测。 2)患者的自测结果与医生对其视网膜病变进展的评估密切相关。 第一阶段项目的成功完成将导致第二阶段的建议，在该阶段中，我们将开发我们的自测系统的生产版本，并进行额外的横向和纵向试验，以进一步验证自测系统的有效性，并为向患者提供自测解决方案的从业者制定具体的指导方针。 公共卫生相关性： 目前，美国有超过500万人患有糖尿病视网膜病变。尽管存在有效的治疗方法，但其中许多人仍面临进一步视力丧失的高风险，因为他们未能及时接受眼科检查，随后在需要时得不到治疗。该SBIR项目旨在开发一种低成本的家庭视力自检系统，使糖尿病患者能够识别显著的视力变化，并在最有效地预防视力丧失时进行治疗。

DESCRIPTION (provided by applicant): In the past decade effective therapies have been developed for diabetic retinopathy (DR), but all too many diabetics who are at high risk for developing the more advanced stages of diabetic retinopathy fail to get even the annual eye exams recommended by AAO, ADA and AMA, and many suffer preventable vision loss as a result. A major objective of RFA-EY-09-001 -- Innovative Patient Outreach Programs and Ocular Screening Technologies to Improve Detection of Diabetic Retinopathy -- is to "develop tools and systems to be used for increasing patient access to eye exams for detecting DR." Vital Art and Science Incorporated (VAS) was founded by a multi- disciplinary group of researchers and business people to specifically address this gap by creating a tool that can be put in the hands of the patient. The VAS goals are to validate and then commercialize a sub-$100 home vision self-test device that healthcare providers could supply to their patients for much more frequent and convenient screening to detect critical diabetic retinopathy state changes. This Phase I SBIR project is a "test of concept" for the prototype vision self-test device that VAS has developed for use in the home to track eye-disease progression. The goals are to assess the ability and willingness of diabetic patients to effectively use this device, as well as its efficacy in identifying when immediate care is needed. We will enroll 40 patients, who have already been diagnosed with diabetic retinopathy, in an 8- month clinical protocol requiring weekly self-testing with our prototype system at home, and scheduled in-office full vision exams (baseline, 4 months, 8 months) that include functional vision testing and retinal imaging analysis. The clinical results will be compared with the self-testing results in order to test the following hypotheses: 1) Patients are willing and able to perform vision self-test at home on a weekly basis. 2) The patients' self-test results strongly correlate with doctor's assessment of the progression of their retinopathy. Successful completion of this Phase I project will lead to a Phase II proposal in which we will develop the production version of our self-test system and perform additional cross-sectional and longitudinal trials to further verify efficacy of the self-test system, and to set specific guidelines for use by practitioners providing our self-test solution to their patients. PUBLIC HEALTH RELEVANCE: Over 5 million people in the US today suffer from diabetic retinopathy. A large number of those are at high risk for further vision loss, even though effective treatments exist, because they fail to receive timely eye exams, and subsequently, do not get treatment when it is needed. This SBIR project seeks to develop a low-cost home vision self-test system which enables diabetes patients to identify significant vision changes and to get treatment when it can be most effective to prevent vision loss.