This SBIR Phase II project seeks to continue development of a low-cost home visio

描述(由申请人提供)： 在过去的十年里，许多新的有效的治疗方法被开发出来用于治疗糖尿病视网膜病变(DR)。这种疗法只有在不可逆转的视网膜损伤之前进行才有效，如果糖尿病患者发展为糖尿病视网膜病变晚期的高危人群甚至无法接受AAO、ADA和AMA推荐的年度眼科检查，就可能发生不可逆转的视网膜损伤。VAS是由研究人员和商界人士组成的多学科小组创建的，旨在通过创建一种低成本和易于使用的诊断工具来专门解决这一问题，使患者能够在家中方便地监控自己的DR进展，并在出现视力丧失的最早迹象时寻求医疗干预。VAS的目标是在临床上验证一种不到100美元的家庭视力功能监测器，然后将其商业化，医疗保健提供者可以为他们的糖尿病患者开出更频繁的筛查，以帮助检测视网膜的关键变化，以便他们可以在尽可能早的时间进行检查和治疗，以最大限度地发挥治疗干预的有效性，并将可预防的视力损失降至最低。这个项目是我们第一阶段的继续，在第一阶段，我们开发了第一代视觉功能测试，并在一名40名DR/DME患者身上成功地进行了测试，6个月的研究验证了患者可以并将有效地使用我们的家庭视力监测器。该第二阶段项目将使VAS能够在我们第一阶段研究反馈的基础上进一步改进产品，在克利夫兰眼科诊所进行第二次可用性测试，并与一家主要制药公司合作，在一项为期12个月的80例DR/DME患者的研究中验证临床敏感性和特异性。这一第二阶段项目的成功完成将直接导致该产品商业化，用于眼科药物试验，使制药公司能够以比目前低得多的成本收集更多关于新视网膜化合物的数据。与制药公司的这种密切合作是实现我们的目标的关键的下一步，我们的目标是为医生提供有效的基于家庭的诊断，以便为他们的糖尿病患者开出处方，用于监测和早期发现重大视力变化，以最大限度地提高治疗干预的有效性，并将可预防的视力损失降至最低。 公共卫生相关性： 今天，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，但这些患者中有很大一部分人视力丧失的风险很高，因为他们没有及时接受眼科检查，随后在最有效的时候没有得到医疗治疗。该SBIR项目旨在开发一种低成本的家庭视觉功能监测器，使医生能够更频繁地监控他们的糖尿病患者，方法是使患者能够在家里进行自己的视力测试，以确定显著的视力变化，并在最有效地防止视力丧失的时候接受治疗。

DESCRIPTION (provided by applicant): In the past decade, a number of new and effective therapies have been developed for the treatment of diabetic retinopathy (DR). Such therapies are only effective if administered prior to irreversible retinal damage which can occur if 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.. Vital Art and Science Incorporated (VAS) was founded by a multi-disciplinary group of researchers and business people to specifically address this problem by creating a low cost and easy to use diagnostic tool which enables the patient to conveniently monitor their own DR progression at home and seek medical intervention at the earliest signs of visual loss. The VAS goals are to clinically validate and then commercialize a sub-$100 home vision function monitor that healthcare providers could prescribe to their diabetic patients for much more frequent screening to help detect critical changes in the retina so they can be examined and treated at the earliest possible time to maximize the effectiveness of therapeutic intervention and minimize preventable loss of vision. This project is a continuation of our Phase I where a first generation vision function test was developed and successfully tested in a 40 DR/DME patient, 6 month Study verifying that patients could and would effectively use our home vision monitor. This Phase II project is to enable VAS to further enhance the product based upon our Phase I Study feedback, perform a second usability test at the Cleveland Eye Clinic, and collaborate with a major pharmaceutical company to validate clinical sensitivity and specificity in an 80 DR/DME patient, 12 month Study. Successful completion of this Phase II project will directly lead to commercialization of the product for use in ophthalmic drug trials enabling pharmaceutical companies to collect significantly more data on new retinal compounds at a much lower cost than is currently possible. Such close collaboration with pharmaceutical companies is a crucial next step in the realization of our objective to provide a validated home based diagnostic for physicians to prescribe to their diabetic patients for monitoring and early detection of significant vision changes to maximize the effectiveness of therapeutic intervention and minimize preventable loss of vision. PUBLIC HEALTH RELEVANCE: Over 5 million people in the US today suffer from diabetic retinopathy. A large number of these patients are at high risk for vision loss, even though effective treatments exist, because they fail to receive timely eye exams, and subsequently, do not get medical treatment when it is most effective. This SBIR project seeks to develop a low-cost home vision function monitor which allows physicians to more frequently monitor their diabetic patients by enabling patients to perform their own vision test at home to identify significant vision changes and to get treatment when it can be most effective to prevent vision loss.