A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming

摘要/摘要 简介：ICARE将通过一段激励性的基于行动的视频提供基于家庭的视觉治疗ff 这个游戏能激励4岁以下的患者坚持到底。拟议的第IIB阶段eff支持 开发商业系统；为提供者和患者提供基于云的工具；建立efficacy 和安全；以及联邦监管部门的批准。 需要解决的问题：融合、ffi、视力和弱视、ff等美国数以百万计的儿童。 这些疾病与头痛、视力模糊、眼睛疲劳、ffi注意力集中等症状有关。 愤怒，甚至更多。他们可能会对孩子的学校和社交表现进行ff测试，并对他们产生不利影响 学习。众所周知，视觉疗法(规定的神经肌肉和神经感觉练习)可以促进 视觉功能的恢复。然而，基于家庭的干预措施在历史上一直是有效的，因为低 依从率。 长期目标：改善被诊断为ffi综合征的儿童的结局和获得护理的机会 还有弱视。 第二阶段结果：在一个成功的第二阶段计划中，一个原型视觉治疗游戏被应用于一个 这项研究涉及被诊断为发育性弱视(n=5)和ffi弱视(n=19)的儿童。从统计学上讲- 在使用iCare超过12周治疗的儿童中，fi没有发现视力明显改善。遵守和 技术验收结果表明，与传统的以计算机为基础的干预相比，情况有所改善。 IIB阶段计划摘要：拟议的IIB effORT产生一个商业iCARE系统，支持 适合4岁以下儿童的视力治疗。新的发展包括：游戏增强，以增加- Porate第二阶段的经验教训；云服务集成；面向提供商的Web应用程序，用于监控和 指导治疗；面向患者的网络应用程序，用于软件下载和父母支持；以及HIPAA- 符合要求的数据存储。寻求联邦监管机构对新设备的批准将包括以下文件 安全；创建用户指南和其他标签；以及完成支持上市前通知的行动。 由美国各地的10家视力治疗提供者组成的网络将参与多点试验，以证明 Effi治疗会聚性弱视和ffi弱视。 商业机会：在美国，大约有470万名视力有问题的儿童 可以通过iCare进行治疗。ICare产品的巨大热情体现在所包含的字母上 包括来自10个不同的ff视力治疗提供者的支持。

Summary/Abstract Introduction: iCare will provide effective, home-based vision therapy through a motivating action-based video game that inspires adherence in patients as young as 4 years old. The proposed Phase IIB effort supports development of the commercial system; cloud-based tools for providers and patients; establishment of efficacy and safety; and federal regulatory approval. Problem to be addressed: Convergence insufficiency and amblyopia affect millions of children in the U.S. These disorders are associated with symptoms including headaches, blurred vision, eyestrain, difficulty concen- trating, and more. They can affect a child's school and social performance and have a detrimental impact on learning. It is known that vision therapy (prescribed neuromuscular and neurosensory exercises) can facilitate restoration of visual function. However, home-based interventions have historically been ineffective due to low adherence rates. Long-Term Goal: Improved outcomes and access to care for children diagnosed with convergence insufficiency and amblyopia. Phase II Results: In a successful Phase II program, a prototype vision therapy game was employed in a study involving children diagnosed with convergence insufficiency (n=19) and amblyopia (n=5). A statistically- significant improvement in vision was found in children who used iCare over 12 weeks of therapy. Adherence and technology acceptance results demonstrated improvement over a conventional computer-based intervention. Phase IIB Program Summary: The proposed Phase IIB effort yields a commercial iCare system supporting vision therapy for children as young as 4 years old. New development includes: game enhancements to incor- porate Phase II lessons learned; cloud services integration; a provider-facing web application for monitoring and guiding therapy; a patient-facing web application for software download and parental support; and a HIPAA- compliant data store. Pursuit of federal regulatory approval for the new device will include documentation of safety; creation of users guide and other labeling; and completion of actions supporting premarket notification. A network of 10 vision therapy providers around the U.S. will participate in multi-site trials to demonstrate efficacy for treatment of both convergence insufficiency and amblyopia. Commercial Opportunity: There are approximately 4.7 million children in the U.S. ages with vision conditions that are treatable by iCare. Tremendous enthusiasm for the iCare product is demonstrated by included letters of support included from 10 different vision therapy providers.