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.

总结/摘要 简介：iCare将通过一个激励行动为基础的视频提供有效的，以家庭为基础的视力治疗 这款游戏激发了年仅4岁的患者的坚持。拟议的IIB期工程支持 开发商业系统;为提供者和患者提供基于云的工具;建立电子商务 以及联邦监管部门的批准。 待解决的问题：会聚性弱视和弱视影响着美国数百万儿童。 这些疾病的症状包括头痛、视力模糊、眼疲劳、注意力不集中等。 trating，等等。它们会影响孩子在学校和社会上的表现，并对他们的生活产生不利影响。 学习众所周知，视觉治疗（规定的神经肌肉和神经感觉练习）可以促进 恢复视觉功能。然而，由于低水平，家庭干预措施历来收效甚微 坚持率。 长期目标：改善被诊断患有融合性营养不良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计划中，一个原型视力治疗游戏被用于一个 研究涉及被诊断为会聚不全（n=19）和弱视（n=5）的儿童。从统计学上看- 在使用iCare超过12周的治疗中，发现视力有显著改善。坚持和 技术验收结果表明，与传统的基于计算机的干预措施相比，技术验收有所改善。 IIB期项目总结：拟议的IIB期项目产生了一个商业iCare系统，支持 为4岁以下的儿童提供视力治疗。新开发包括：incor的游戏增强功能- 传播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， 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- 兼容的数据存储。新器械的联邦监管批准将包括以下文件： 安全性;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。 一个由美国10家视力治疗提供商组成的网络将参与多地点试验，以证明 治疗会聚不全和弱视疗效显著。 商业机会：美国大约有470万儿童患有视力问题 iCare可以治疗的疾病对iCare产品的巨大热情体现在所附的信件中 的支持包括来自10个不同的视力治疗提供者。

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