A new generation, enhanced, corneal-birefringence-independent retinalscanning device for pediatric vision disorders using polarization modulation

新一代增强型、独立于角膜双折射的视网膜扫描装置，利用偏振调制治疗儿科视力障碍

• 批准号: 9907989
• 负责人: Boris Gramatikov
• 金额: $ 22.5万
• 依托单位: REBISCAN, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907989
• 关键词: 2 year old; Adopted; Adoption; Affect; Age; Amblyopia; Anisometropia; Birefringence; Blindness; Caring; Child; Childhood; Code; Collaborations; Computer Models; Cornea; Data; Databases; Detection; Device Designs; Devices; Disease; Early Diagnosis; Evaluation; Eye; Eye diseases; Financial compensation; Funding; Generations; Hand; Human; Insurance; Intervention; Laboratories; Lazy Eyes; Left; Legal patent; Light; Measures; Mechanics; Medical; Methods; Modeling; Nerve Fibers; Noise; Only Child; Optics; Outcome; Output; Patients; Pattern; Performance; Phase; Population; Prevalence; Privatization; Publishing; Pupil; Quality of Care; Reproducibility; Research; Research Personnel; Retina; Risk Factors; Running; Scanning; Scientist; Signal Transduction; Source; Specialist; Specificity; Strabismus; Structure; Subtraction Technique; System; Techniques; Technology; Testing; United States; Universities; Vision; Vision Disorders; Vision Screening; Work; base; care costs; care outcomes; deprivation; design; digital; improved; innovation; liquid crystal; mathematical model; neglect; new technology; novel; operation; phase 1 study; polarized light; sample fixation; screening; stem

Project Summary/Abstract ! Amblyopia is vision loss caused by neglect of a structurally normal eye due to strabismus, asymmetric refraction (anisometropia), or deprivation. It is irreversible if not treated by age 7, but half of all patients in the U.S. are undetected and untreated until after it is too late, making it the leading cause of preventable vision loss. Rebion (Rebiscan, Inc) has developed retinal birefringence scanning (RBS) into a commercial product, the RBS-based “blinq” device, which detects amblyopia and strabismus with 94% accuracy, compared with 69% accuracy of non-RBS methods. Although blinq effectively screens for strabismus and amblyopia by direct detection of these conditions with very high sensitivity (97%), published “specificity” of the device is closer to 87%. Given the 5% prevalence of amblyopia and strabismus, this means that 2 normal patients could potentially be referred for every treatable case. It is therefore essential that “specificity” of blinq be improved if the device is to be adopted widely. One likely cause of false referrals is corneal birefringence, which can interfere with an RBS test. Unlike retinal birefrigence, corneal birefringence can vary greatly between patients and cause inaccurate RBS results. If corneal birefringence could be neutralized as a factor in RBS, the specificity of the blinq device could likely be improved to equal or exceed the device's 97% sensitivity. Leading researchers at Johns Hopkins University (JHU) have developed a novel, patented approach that incorporates corneal birefringence compensation in an RBS system. This approach can be readily optimized within blinq's current mechanical and electrical design. In this Phase I study, we believe that by collaborating with the JHU research team, we will be able to develop a new device that produces significant advantages over existing technologies, including the commercially available blinq device. Applying JHU's research advancements to the FDA-cleared blinq device will allow rapid commercial adoption of a breakthrough technology for detection of amblyopia. The improved end result is that vision screening in the real world will immediately improve and save thousands of children from unnecessary vision loss. Successful execution of this project will help improve the quality of care and outcomes for thousands of children annually, while simultaneously reducing the costs of care for all.

项目摘要/摘要 呢 弱视是由于忽视结构正常眼而引起的视力丧失 斜视，不对称折射（肛门图）或剥夺。如果不治疗，这是不可逆转的 到7岁，但是美国的所有患者中有一半一直未被发现且未治疗，直到为时已晚， 使其成为可预防视力丧失的主要原因。 Rebion（Repiscan，Inc）已开发 视网膜双重扫描（RBS）进入商业产品，基于RBS的“ Blinq”设备， 它以94％的精度检测弱视和斜视，而精度为69％ 非RBS方法。 尽管Blinq通过直接检测有效地筛选了斜视和弱视 这些条件具有很高的灵敏度（97％），该设备的“特异性”更接近 87％。考虑到弱视和斜视的5％患病率，这意味着2例正常患者 每个治疗案例都可以参考。因此，至关重要的是 如果要广泛采用该设备，则可以改进BLINQ。一个可能的错误推荐原因是 角膜双折射，可能会干扰RBS测试。与视网膜双折射不同，角膜 患者之间的双折射可能差异很大，并导致不准确的RBS结果。如果角膜 双折射可以作为RB的一个因素中和，Blinq设备的特异性可以 可能会提高到相等或超过设备的97％灵敏度。 约翰·霍普金斯大学（JHU）的主要研究人员开发了一部小说 专利的方法在RBS系统中包含角膜双重补偿。 可以在Blinq当前的机械和电气设计中轻松优化这种方法。 在此阶段我的研究中，我们相信，通过与JHU研究团队合作，我们将成为 可以开发一种新设备，该设备比现有技术产生显着优势， 包括市售的Blinq设备。 将JHU的研究进步应用于FDA清除的BLINQ设备将允许快速 商业采用突破性技术以检测弱视。改进 最终结果是现实世界中的视力筛查将立即改善并节省数千个 不必要的视力丧失的孩子。该项目的成功执行将有助于改进 每年成千上万的孩子的护理质量和结果同时 降低所有人的护理费用。