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

基于自然 3D 计算机游戏的视觉治疗新方法

• 批准号: 9455693
• 负责人: Richard J. Adams
• 金额: $ 86.02万
• 依托单位: BARRON ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9455693
• 关键词: 3-Dimensional; 4 year old; Address; Adherence; Affect; Age; Agreement; Amblyopia; Asthenopia; Award; Binocular Vision Disorder; Blurred vision; Businesses; Caring; Child; Child Care; Child Support; Clinic; Clinical Research; Cloud Service; Complement; Computer software; Computers; Contrast Sensitivity; Convergence Insufficiency; Custom; Data; Development; Devices; Diagnosis; Disease; Documentation; Exercise; Exercise Therapy; Eye; Frequencies; Generations; Goals; Head; Headache; Health Insurance Portability and Accountability Act; Health Services Accessibility; Home environment; Human; Impairment; Improve Access; Incidence; Intervention; Label; Lead; Learning; Letters; Measures; Methods; Modeling; Monitor; Motivation; Multicenter Trials; New Device Approvals; North Dakota; Notification; Optometrist; Optometry; Parents; Participant; Patient Noncompliance; Patients; Performance; Phase; Play; Private Practice; Product Labeling; Provider; Quality of life; Questionnaires; Research; Research Personnel; Risk; Safety; Schools; Secure; Services; Supervision; Support System; Symptoms; System; Techniques; Technology; Testing; Therapeutic; Treatment Efficacy; Universities; Video Games; Vision; Visual Acuity; base; classical conditioning; cloud based; computer game; contrast enhanced; data management; early childhood; improved; improved outcome; innovation; multi-site trial; neuromuscular; neurosensory; novel strategies; programs; prototype; psychologic; recruit; restoration; social; standard care; success; therapy outcome; tool; usability; web app; web services; web-enabled

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.

摘要/摘要 简介：iCare 将通过激励性的行动视频提供有效的家庭视力治疗 激发 4 岁患者依从性的游戏 拟议的 IIB 期工作支持。 为提供者和患者开发基于云的工具； 和安全；以及联邦监管部门的批准。 要解决的问题：收敛不足和弱视影响着美国数百万儿童。 这些疾病与头痛、视力模糊、眼睛疲劳、注意力不集中等症状相关。 它们会影响孩子的学业和社交表现，并对孩子产生痛苦的影响。 众所周知，视觉疗法（规定的神经肌肉和神经感觉练习）可以促进学习。 然而，由于视力低下，以家庭为基础的干预措施历来都是无效的。 遵守率。 长期目标：改善被诊断患有融合不足的儿童的治疗结果和获得护理的机会 和弱视。 第二阶段结果：在一个成功的第二阶段项目中，原型视觉治疗游戏被用于 这项研究涉及被诊断患有会聚不足 (n=19) 和弱视 (n=5) 的儿童。 使用 iCare 治疗 12 周以上的儿童的视力有显着改善。 技术接受结果表明，与传统的基于计算机的干预相比有所改善。 IIB 阶段计划摘要：拟议的 IIB 阶段工作产生了一个商业 iCare 系统，支持 针对 4 岁儿童的视觉治疗 新开发包括： 增强游戏功能。 企业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，用于软件下载和家长支持；以及 HIPAA- 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 10 家视力治疗提供者组成的网络将参与多地点试验以证明 治疗会聚不足和弱视的功效。 商业机会：美国大约有 470 万儿童患有视力问题 可以通过 iCare 进行治疗 随附的信件表明了对 iCare 产品的巨大热情。 包括来自 10 家不同视力治疗提供者的支持。

项目成果

Effectiveness of a Novel Video Game Platform in the Treatment of Pediatric Amblyopia.

新型视频游戏平台治疗小儿弱视的有效性。

• 发表时间: 2024
• 影响因子: 1.2
• 作者: Poltavski, Dmitri;Adams, Richard J;Biberdorf, David;Patrie, James T
• 通讯作者: Patrie, James T