Mobile medical application for cost-effective strabismus screening

项目摘要/摘要 在这个项目中，我们建议完成一个基于智能手机的开发和性能评估 供眼科护理专业人员和普通人使用的移动医疗应用程序(EyeTurn) 斜视(眼睛错位)。据估计，斜视在美国人口中的发病率为3%-8%，是一种 幼儿弱视的主要危险因素。早期发现和治疗是预防该病的关键 永久性视力丧失，但据报道，只有40%的6岁以下美国儿童接受了视力筛查。在 在发病率最高的老年人和头部创伤人群中，未经治疗的斜视可能会导致 姿势不稳定，导致更大的毁灭性跌倒的风险。然而，重大障碍是 受过培训的检查员的费用和可获得性限制了对高危人群进行斜视筛查的机会，尤其是 在服务不足的农村和低收入地区以及老年护理设施。新奇的EyeTurn应用程序提供了第一个 基于图像的工具，用于外行人员进行眼睛对准测试，而不需要依赖昂贵的设备。我们建议 进一步开发EyeTurn应用程序，以提高自动眼睛检测和垂直斜视的可靠性 测量，添加符合HIPAA的患者数据管理，改进操作员界面，以覆盖- 发现测试和筛查/家庭使用，并包含用于用户培训、患者教育和 医生发现了。我们将根据目标测试中的标准测试方法评估EyeTurn的性能 可能包含难以准确测量的对象的人群，包括幼儿和 头部创伤或低视力患者。我们还将报告对EyeTurn敏感性和特异性的初步估计 小儿科筛查的试点应用。在第二阶段项目结束时，我们将拥有 已证明的准确性、可靠性和有效范围可与目前采用的昂贵测试相媲美或超过 在斜视筛查中。将这种低成本产品推向广泛的商业市场，我们可以使 全球斜视筛查和测量成本效益计算的范式转变，导致 使受斜视影响的个人更容易获得治疗。被证明有效的视觉效果 护理专业人员将定位EyeTurn以申请FDA上市前批准并在 支持外行人使用斜视筛查。

PROJECT SUMMARY/ABSTRACT In this project we propose to complete development and performance evaluation of a smartphone-based mobile medical application (EyeTurn) for use by eye-care professionals and lay people to screen for strabismus (eye misalignment). Strabismus develops in an estimated 3-8% of the U.S. population and is a leading risk factor for amblyopia in young children. Early detection and treatment are critical to prevention of permanent vision losses, yet only 40% of U.S. children under age 6 reportedly receive vision screening. In the elderly and in head trauma populations where the prevalence is highest, untreated strabismus can result in postural instability, leading to a significantly greater risk of devastating falls. However, significant barriers of cost and availability of trained examiners limit access to strabismus screening for at-risk populations, especially in under-served rural and low-income areas and elder care facilities. The novel EyeTurn app provides the first image-based tool for eye alignment testing by lay persons without reliance on a costly device. We propose to further develop the EyeTurn app to improve reliability of automatic eye detection and vertical strabismus measurement, add HIPAA-compliant patient data management, improve the operator interface for cover- uncover testing and for screening/home use, and incorporate modules for user training, patient education, and doctor finding. We will evaluate EyeTurn performance relative to standard test methodology in targeted populations likely to contain subjects who are difficult to accurately measure, including both young children and head trauma or low vision patients. We will also report initial estimates of EyeTurn sensitivity and specificity in a pilot-scale application to pediatric screening. At the conclusion of the Phase II project, we will have demonstrated accuracy, reliability and effective range comparable to or exceeding costly tests now employed in strabismus screening. Bringing this low cost product to wide commercial availability, we could make possible a paradigm shift in cost-benefit calculations for strabismus screening and measurement globally, resulting in greater access to treatment for strabismus-affected individuals. A demonstrated effectiveness for use by vision care professionals will position EyeTurn to apply for FDA pre-market approval and perform clinical trials in support of use by lay people for strabismus screening.