Visual & Memory Stimulating (VMS) Grid Self-Monitoring Tests

描述（由申请人提供）：年龄相关性黄斑变性（AMD）仍然是当今美国50岁以上人群中央视力丧失的主要原因，随着婴儿潮一代达到退休年龄，这一疾病可能会成为流行病。在过去的15年里，已经有了治疗晚期AMD的方法(1)，但这些进展的有效性受到了挑战，因为患者在定期就诊之间缺乏识别紧急护理需求的能力。Amsler和Yanuzzi测试是唯一被广泛使用的黄斑变性自我测试，但事实证明，这两种测试在很大程度上无法让患者识别出应该咨询视网膜专家进行治疗的迹象。为了获得最佳效果，患者应该能够观察到视力随时间的变化。阿姆斯勒网格的主要缺点是测试模式的周期性和缺乏个体调整。在目前的研究中，我们已经开发了几个版本的改进网格，包括在纸上和在互联网上。这些正在申请专利的视觉和精神刺激（VMS）网格被假设为促进对先前测量的很大程度的回忆，这是随时间监测视觉所必需的。调整功能也被纳入，允许患者自定义他们的网格，以他们的特定视野。在初步研究中，从AMD患者和视网膜专家那里获得了对初始原型的积极反馈。结果将导致更快速地识别问题，更早地诊断和治疗，从而减少失去视力的人。本项目将进行三个方面的研究：1 .准备适合测试的纸质和电子原型。我们将继续开发原型，以实现可靠的测试工具，形式化静态测试元素，并开发基于web的工作流逻辑方法和数据库支持的动态调整工具。在约翰霍普金斯大学的Wilmer眼科研究所，我们将招募25名新近发病的单侧AMD患者（第一组），目前由一位视网膜专家治疗。该研究将在6周的时间内比较新型自我诊断VMS工具与当前自我监测工具（特别是Amsler网格）的结果。目前的临床工具（FA， OCT和ICG）将用于确定参考基线。我们将招募两组患者，每组50名新近发病的单侧AMD患者，目前正在接受视网膜专家的治疗（第2组，康涅狄格州队列）或有AMD风险（第3组，巴尔的摩队列），并测量他们在没有第三方支持的情况下访问和使用VMS工具的能力。病人使用系统的成功程度和他们对结果的信心程度将通过问卷调查确定。公共卫生相关性：在西方世界，年龄相关性黄斑变性（AMD）是不可逆转的法定失明的主要原因。目前AMD患者的自我监测工具不能充分显示需要立即注意的病理性视力变化，从而导致治疗开始延迟和严重视力丧失的发生率较高。通过一种新颖的视觉和记忆刺激工具（VMS）的应用，该项目将提高患者在办公室就诊之间准确、自信地自我监测AMD的能力，从而减少失去视力的人。

DESCRIPTION (provided by applicant): Age-related macular degeneration (AMD) continues to be the leading cause of central vision loss in the US today for those over fifty years of age and will likely become epidemic as Baby Boomers reach retirement age. Over the last 15 years treatments have become available to treat advanced AMD (1) but effectiveness of these advances is challenged by patients' lack of ability to recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling patients to recognize the signs that they should consult their retina specialist for treatment. For optimal benefit, patients should be able to observe changes in their vision over time. The principal shortcomings of the Amsler grid include periodicity of the test pattern and lack of individual adjustment. For the current study, we have developed several versions of improved grids, both on paper and on the Internet. These patent-pending Visual and Mental Stimulation (VMS) grids are hypothesized to facilitate a substantial degree of recall of prior measurements, necessary for monitoring vision over time. Adjustment features have also been incorporated to allow patients to customize their grid to their particular visual field. In preliminary studies, positive feedback was obtained on initial prototypes from AMD patients and retina specialists. The result will lead to more rapid identification of problems, earlier diagnosis and treatment that will result in fewer people losing their vision. This project will pursue three areas of study: 1 Preparation of paper & electronic prototypes suitable for testing We will continue development of prototypes towards a reliable test tool, formalizing static testing elements and developing dynamic adjustment tools supported by a web-based work-flow logic approach and database. 2 - Comparative study of novel solutions with current prevailing test At the Wilmer Eye Institute of Johns Hopkins University, we will recruit 25 patients (Group 1) with recent onset of unilateral AMD under current care of a retina specialist. The study will compare the results of the novel self-diagnostic VMS tools with current self-monitoring tools (specifically the Amsler grid) over a 6 week period. Current clinical tools (FA, OCT & ICG) will be used to determine a reference baseline. 3 Study to gain feedback of patients' use of tests outside a clinical environment We will recruit two cohorts of 50 patients with recent onset of unilateral AMD under current care of a retina specialist (Group 2, Connecticut cohort) or at risk of AMD (Group 3, Baltimore cohort), and measure their ability to access and utilize the VMS tools without 3rd party support. Patients' success in using the system and their confidence level in results will be ascertained through a questionnaire. PUBLIC HEALTH RELEVANCE: Age-related macular degeneration (AMD) is the major cause of irreversible legal blindness in the western world. Current self-monitoring tools in patients with AMD fail to adequately indicate pathological vision changes that require immediate attention thus resulting in delayed treatment starts and higher incidences of severe vision loss. Through the application of a novel Visual and Memory Stimulating tool (VMS) this project will improve patients' ability to accurately and confidently self-monitor their AMD between office visits resulting in fewer people losing their vision.