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

描述(申请人提供)：年龄相关性黄斑变性(AMD)仍然是当今美国50岁以上人群中心视力丧失的主要原因，并可能随着婴儿潮一代达到退休年龄而流行。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患者缺乏认识到在定期办公室就诊之间需要紧急护理的能力的挑战。Amsler和Yanuzzi测试是唯一被广泛使用的AMD自我测试，事实证明，它们在让患者识别他们应该咨询视网膜专家进行治疗的迹象方面基本上无效。为了达到最佳效果，患者应该能够观察到随着时间的推移他们视力的变化。Amsler网格的主要缺点包括测试模式的周期性和缺乏个别调整。对于目前的研究，我们已经开发了几个版本的改进网格，既有纸质的，也有互联网上的。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相当程度的回忆，这是随着时间的推移监测视力所必需的。还加入了调整功能，允许患者根据他们特定的视野定制他们的网格。在初步研究中，AMD患者和视网膜专家对最初的原型进行了积极的反馈。结果将导致更快地发现问题，更早地诊断和治疗，从而减少失明的人。这个项目将进行三个领域的研究：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，将静态测试元素形式化，并开发基于网络的工作流逻辑方法和数据库支持的动态调整工具。2-新解决方案的比较研究与约翰·霍普金斯大学威尔默眼科研究所目前流行的测试，我们将招募25名新近发病的单侧AMD患者(第1组)，目前由视网膜专家治疗。这项研究将在6周的时间内将新型自我诊断VMS工具与当前自我监测工具(特别是Amsler GRID)的结果进行比较。将使用当前的临床工具(FA、OCT和ICG)来确定参考基线。3研究获取患者在临床环境外使用测试的反馈我们将招募两组50名最近在视网膜专家(第2组，康涅狄格州队列)或有AMD风险(第3组，巴尔的摩队列)护理下新发单侧AMD的患者，并衡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。患者使用该系统的成功程度和他们对结果的置信度将通过问卷调查来确定。公共卫生相关性：老年性黄斑变性(AMD)是西方世界不可逆转的法律失明的主要原因。目前AMD患者的自我监测工具不能充分显示需要立即关注的病理性视力变化，从而导致治疗开始延迟和严重视力丧失的发生率更高。通过应用一种新的视觉和记忆刺激工具(VMS)，该项目将提高患者在办公室就诊期间准确和自信地自我监测AMD的能力，从而减少失明人数。

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.