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

该 SBIR 第二阶段项目旨在继续开发低成本家庭视觉

• 批准号: 8199307
• 负责人: Michael B. Bartlett
• 金额: $ 52.97万
• 依托单位: VITAL ART AND SCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8199307
• 关键词: Address; Aftercare; Arts; Blindness; Businesses; Clinic; Clinical Sensitivity; Collaborations; Data; Development; Diabetic Retinopathy; Diagnostic; Disease; Early Diagnosis; Effectiveness; Exudative age-related macular degeneration; Eye; Feedback; Generations; Goals; Gold; Health Personnel; Home environment; Intervention; Lead; Marketing; Measures; Medical; Monitor; Ophthalmic examination and evaluation; Patient Monitoring; Patients; Pharmacologic Substance; Phase; Physicians; Research; Research Personnel; Retina; Retinal; Science; Screening procedure; Sensitivity and Specificity; Small Business Innovation Research Grant; Staging; System; Testing; Therapeutic Intervention; Time; Vision; Vision Tests; base; commercialization; cost; diabetic; diabetic patient; effective therapy; functional improvement; high risk; improved; ophthalmic drug; phase 1 study; prevent; retinal damage; tool; usability

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.

描述（由申请人提供）： 在过去的十年中，已经开发了许多新的和有效的疗法用于治疗糖尿病视网膜病变（DR）。这些治疗只有在不可逆的视网膜损伤之前给药才有效，如果处于发展糖尿病视网膜病变更晚期的高风险的糖尿病患者甚至不能得到AAO，ADA和AMA推荐的年度眼科检查，则可能发生不可逆的视网膜损伤。Vital Art and Science Incorporated（VAS）由多学科的研究人员和商业人士组成的小组创立，旨在通过创建一种低成本且易于使用的诊断工具来专门解决这一问题，该工具使患者能够方便地在家中监测自己的DR进展，并在视力丧失的最早迹象时寻求医疗干预。VAS的目标是临床验证，然后商业化一个低于100美元的家庭视力功能监测器，医疗保健提供者可以开给他们的糖尿病患者更频繁的筛查，以帮助检测视网膜的关键变化，以便他们可以检查和治疗在尽可能早的时间，以最大限度地提高治疗干预的有效性，并最大限度地减少可预防的视力丧失。该项目是我们第一阶段的延续，第一阶段开发了第一代视觉功能测试，并在40名DR/DME患者中成功进行了测试，为期6个月的研究验证了患者能够并将有效地使用我们的家用视觉监视器。该II期项目旨在使VAS能够根据我们的I期研究反馈进一步增强产品，在克利夫兰眼科诊所进行第二次可用性测试，并与一家大型制药公司合作，在80名DR/DME患者中验证临床灵敏度和特异性，12个月研究。该II期项目的成功完成将直接导致该产品用于眼科药物试验的商业化，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目标的关键一步，即为医生提供经验证的家庭诊断，以便为糖尿病患者开具处方，以监测和早期发现显著的视力变化，从而最大限度地提高治疗干预的有效性并最大限度地减少可预防的视力丧失。 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，但这些患者中的大量患者仍处于视力丧失的高风险中，因为他们未能及时接受眼科检查，并且随后在最有效的时候没有得到治疗。该SBIR项目旨在开发一种低成本的家庭视力功能监测仪，使医生能够更频繁地监测他们的糖尿病患者，使患者能够在家中进行自己的视力测试，以识别显着的视力变化，并在最有效的情况下进行治疗，以防止视力丧失。