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.

项目概要/摘要 ！ 弱视是由于忽视结构正常的眼睛而导致的视力丧失 斜视、不对称屈光（屈光参差）或屈光不正如果不治疗，是不可逆转的。 到 7 岁时，但美国有一半的患者没有被发现和治疗，直到为时已晚， 使其成为可预防视力丧失的主要原因。 将视网膜双折射扫描 (RBS) 转化为商业产品，即基于 RBS 的“blinq”设备， 它检测弱视和斜视的准确率高达 94%，而普通机器的准确率只有 69% 非 RBS 方法。 尽管 blinq 通过直接检测来有效筛查斜视和弱视 这些条件具有非常高的灵敏度（97％），已发表的设备的“特异性”更接近 鉴于弱视和斜视的患病率为 5%，这意味着 2 名正常患者。 因此，每一个可治疗的病例都可能被转诊，因此“特异性”至关重要。 如果要广泛采用该设备，blinq 就需要改进，造成错误推荐的一个可能原因是。 角膜双折射，与视网膜双折射不同，角膜双折射会干扰 RBS 测试。 患者之间的双折射差异很大，导致 RBS 结果不准确。 双折射作为 RBS 的一个因素可以被中和，blinq 装置的特异性可以 可能会提高到等于或超过设备 97% 的灵敏度。 约翰·霍普金斯大学 (JHU) 的领先研究人员开发了一种新颖的、 专利方法将角膜双折射补偿纳入 RBS 系统。 这种方法可以在 blinq 当前的机械和电气设计中轻松优化。 在这一阶段的研究中，我们相信通过与 JHU 研究团队的合作，我们将 能够开发出比现有技术具有显着优势的新设备， 包括市售的 blinq 设备。 将 JHU 的研究进展应用于 FDA 批准的 blinq 设备将允许快速 商业采用突破性的弱视检测技术。 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人的费用 该项目的成功实施将有助于改善儿童不必要的视力丧失。 每年为数千名儿童提供护理质量和结果，同时 降低所有人的护理成本。