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

项目总结/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）或剥夺。如果不治疗是不可逆的 但在美国，有一半的患者没有被发现，也没有得到治疗，直到为时已晚， 使其成为可预防的视力丧失的主要原因。Rebion（Rebiscan，Inc）开发了 视网膜双折射扫描（RBS）到商业产品中，基于RBS的“blinq”设备， 它检测弱视和斜视的准确率为94%，而 非RBS方法。 虽然blinq通过直接检测斜视和弱视有效地筛选， 这些条件具有非常高的灵敏度（97%），公布的“特异性”的设备更接近 百分之八十七鉴于弱视和斜视的患病率为5%，这意味着2名正常患者 都有可能被转介到每一个可治疗的病例中。因此，至关重要的是， 如果要广泛采用这种装置，就必须改进它。虚假推荐的一个可能原因是 角膜双折射，这可能会干扰RBS测试。与视网膜双折射不同， 双折射在患者之间可能变化很大，并导致不准确的RBS结果。如果角膜 双折射作为RBS中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的97%的灵敏度。 约翰霍普金斯大学（JHU）的主要研究人员开发了一种新的， 该专利方法在RBS系统中集成了角膜双折射补偿。 这种方法可以很容易地在blinq目前的机械和电气设计优化。 在第一阶段的研究中，我们相信通过与JHU研究团队合作，我们将 能够开发出一种比现有技术具有显著优势的新设备， 包括市售的Blinq装置。 将JHU的研究进展应用于FDA批准的Blinq设备将允许快速 商业上采用了一项突破性的弱视检测技术。改进的 最终的结果是，在真实的世界中进行视力筛查将立即改善并挽救数千人的生命 儿童不必要的视力丧失。该项目的成功实施将有助于提高 每年为数千名儿童提供的护理质量和成果，同时 降低所有人的医疗成本。

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.