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将通过激励基于动作的视频来提供有效的家庭视觉治疗 激发4岁患者依从性的游戏。拟议的IIB阶段支持 商业系统的开发；提供者和患者的基于云的工具；建立效率 和安全；和联邦法规批准。 要解决的问题：融合不适当和弱视影响美国数百万儿童 这些疾病与症状有关，包括标题，视力模糊，眼睛疲劳，困难的问题 - 跟踪等等。他们可以学校的学校和社会表现，并对 学习。众所周知，视力疗法（规定的神经肌肉和神经感觉运动）可以促进 恢复视觉功能。但是，由于低较低，基于家庭的干预措施是无效的 依从率。 长期目标：改善结果并获得诊断为融合效果的儿童的护理机会 和弱视。 第二阶段的结果：在成功的II期计划中，在A中进行了原型视觉治疗游戏 涉及诊断为融合不可能效率（n = 19）和弱视（n = 5）的儿童的研究。统计上的 在12周的治疗中使用ICARE的儿童中发现了视力的显着改善。依从性和 技术接受结果表明，基于计算机的干预措施有所改善。 IIB阶段计划摘要：拟议的IIB阶段会产生支持的商业ICARE系统 4岁以下儿童的视力疗法。新开发包括：Incor的游戏增强功能 - 学会的porate二期课程；云服务集成；面向提供商的Web应用程序，用于监视和 指导疗法；面向患者的Web应用程序，用于软件下载和父母支持；和一个hipaa- 合规数据存储。追求联邦监管机构对新设备的批准将包括 安全;创建用户指南和其他标签；并完成支持上市通知的措施。 美国各地的10个视力疗法提供者的网络将参加多站点试验以证明 治疗收敛性不佳和弱视的效果。 商业机会：美国年龄大约有470万儿童具有视力条件 可以通过ICARE治疗。包括信件证明了对Icare产品的极大热情 包括10个不同视力疗法提供者的支持。

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。

• DOI: 10.3928/01913913-20230324-01
• 发表时间: 2024
• 期刊: Journal of pediatric ophthalmology and strabismus
• 影响因子: 1.2
• 作者: Poltavski,Dmitri;Adams,RichardJ;Biberdorf,David;Patrie,JamesT
• 通讯作者: Patrie,JamesT