Develop and Validate a Prosthetic Low Vision Rehabilitation (PLoVR) Curriculum

开发并验证假肢低视力康复 (PLoVR) 课程

• 批准号: 8435523
• 负责人: Gislin Dagnelie
• 金额: $ 38.95万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-01-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8435523
• 关键词: Area; Blindness; Clinical; Clinical Research; Clinical Trials; Data; Development; Documentation; Educational Curriculum; Effectiveness; Electronics; Environment; Evaluation; Eye diseases; Future; Goals; Implant; Individual; Instruction; Laboratories; Manuals; Measures; Medical; Methods; Modality; Ocular Prosthesis; Outcome; Participant; Patient Education; Patient Self-Report; Patients; Performance; Persons; Phase I Clinical Trials; Procedures; Prosthesis; Reading; Rehabilitation therapy; Research; Research Personnel; Retinal; Retinal Diseases; Scoring Method; Shapes; Site; Specialist; Spottings; Surveys; System; Task Performances; Test Result; Testing; Training; Update; Vision; Visual; Visual impairment; Work; blind; design; effectiveness measure; experience; eye hand coordination; information gathering; insight; patient population; pre-clinical; programs; prospective; response; simulation; tool; trait; visual information; visual performance

Retinal implants are being pursued by some 18 groups around the world, have been tested acutely by at least 5, and are being evaluated clinically by at least one consortium currently and by another 3 within the next year. Second Sight Medical Products (SSMP) has been developing tools to train and test implant recipients in its Argus" II trial, mostly in response to its own need and requirements by the FDA to quantify and document prosthesis function and patient performance. Some procedures were developed within SSMP, while others build on existing tests and training materials developed in low vision rehabilitation, in visual prosthesis trials, in pre-clinical visual prosthesis studies, and in prosthetic vision simulations. Yet, while building blocks of a future rehab curriculum do exist, no integrated approach to prosthetic low vision rehabilitation has been formulated. The immediate goal of the proposed program is to integrate, refine, and create tools for assessment and rehabilitation of ultra-low vision into a program that will provide research and clinical teams in the area of electronic visual prosthetics with the means to train, track, and evaluate implant patients, and collect the outcomes required to demonstrate functional effectiveness. The resulting ensemble of training and assessment tools, along with manuals and on-line course materials, will form a Prosthetic Low Vision Rehabilitation (PLoVR) curriculum. Specifically, we propose to 1. Expand the scale of visual tasks and abilities used in low vision rehabilitation towards ultra-low vision. A population of patients with extremely limited vision will create a "bank" of activities, and be asked to rank these according to difficulty; a logit scale of item measures will be created through Rasch analysis. 2. Design and refine practice and assessment tools for minimally sighted individuals. We will create, and expand on, tools that stimulate and assess the use of vision (visual information gathering and of visually guided performance) and develop scoring systems and composite outcomes. 3. Evaluate the use of practice and assessment tools in patients with severe and profound vision loss. A group of ultra-low vision subjects will perform the tasks developed under Aim 2, for multiple parameter settings; Rasch analysis will be used to assign a difficulty score to each task and parameter setting.. 4. Validate the tools and scoring system in experienced and new retinal implant recipients. A group of 10 retinal implant wearers will practice and perform the same tasks; Rasch analysis will be used to examine potential differences between the two subject groups 5. Disseminate the PLoVR core curriculum: surveys, performance tasks, instructions and documentation We will create instruction manuals, an on-line course, and a user group for future PLoVR curriculum users. The PLoVR curriculum will be made available to research consortia pursuing treatment modalities for advanced eye disease, as a uniform set of standards to demonstrate clinical and functional effectiveness.

全球约有18个组织正在进行视网膜植入物的研究，至少经过了严格的测试 5，目前至少有一个财团正在进行临床评估，明年将有另外3个财团对其进行评估。 第二视力医疗产品公司(SSMP)一直在开发工具，以培训和测试其 Argus“II试验，主要是为了回应其自身的需要和FDA对其进行量化和记录的要求 假体功能和患者表现。有些程序是在SSMP内开发的，而另一些则是 建立在现有的低视力康复、视觉假体试验、 临床前视觉假体研究，以及假体视觉模拟。然而，在构建未来的积木的同时 康复课程确实存在，但还没有制定出修复低视力的综合方法。 拟议计划的直接目标是集成、改进和创建评估和 将超低视力康复纳入一项计划，该计划将在以下领域提供研究和临床团队 电子视觉假体，具有培训、跟踪和评估植入患者的手段，并收集 证明功能有效性所需的结果。由此产生的训练和合奏 评估工具，以及手册和在线课程材料，将形成假体低视力 康复(PLoVR)课程。具体来说，我们建议 1.将低视力康复中使用的视觉任务和能力的规模向超低视力扩展。 一群视力极其有限的患者将创建一系列活动，并被要求进行排名 这些将根据难度；将通过Rasch分析创建项目测量的Logit量表。 2.设计和完善针对弱视人士的练习和评估工具。 我们将创建并扩展刺激和评估视觉(视觉信息)使用的工具 收集和分析视觉指导的绩效)，并制定评分系统和综合结果。 3.评估实践和评估工具在重度和深度视力丧失患者中的使用情况。 一组超低视力受试者将执行目标2中制定的多参数任务 设置；RASCH分析将用于为每个任务和参数设置分配难度分数。 4.验证工具和评分系统在有经验的和新的视网膜植入患者中的有效性。 由10名视网膜植入者组成的小组将练习并执行相同的任务；将使用Rasch分析 检查两组受试者之间的潜在差异 5.传播PLoVR核心课程：调查、表演任务、说明和文件 我们将为未来的PLoVR课程用户创建指导手册、在线课程和用户组。 PLoVR课程将提供给寻求治疗方法的研究联盟 晚期眼病，作为一套统一的标准来证明临床和功能的有效性。