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: 8209150
• 负责人: Gislin Dagnelie
• 金额: $ 50.74万
• 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/8209150
• 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.

全世界有18个组织正在研究视网膜植入物， 5，目前至少有一个联盟正在进行临床评估，明年将有另外3个联盟进行临床评估。 Second Sight Medical Products（SSMP）一直在开发工具，以培训和测试植入物接受者， Argus”II试验，大多是为了响应其自身的需要，并要求由FDA进行量化和记录 假体功能和患者表现。有些程序是在SSMP内开发的，而其他程序则是在SSMP内开发的 在低视力康复、视觉假体试验、 临床前视觉假体研究和假体视觉模拟。然而，在构建未来的同时， 虽然有康复课程，但没有制定假肢低视力康复的综合方法。 该计划的近期目标是整合、完善和创建评估工具， 超低视力的康复纳入一个计划，将提供研究和临床团队在该地区， 电子视觉修复术，用于培训、跟踪和评估植入患者，并收集 证明职能有效性所需的成果。由此产生的培训和 评估工具，沿着手册和在线课程材料，将形成一个人工低视力 康复（PLoVR）课程。具体而言，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扩大到超低视力。 一群视力极其有限的患者将创建一个活动“银行”，并被要求进行排名。 这些根据难度;将通过Rasch分析创建项目测量的logit量表。 2.设计和完善实践和评估工具，为最低限度的视力个人。 我们将创建并扩展刺激和评估视觉（视觉信息）使用的工具 收集和视觉引导性能），并开发评分系统和综合结果。 3.评估实践和评估工具在严重和深度视力丧失患者中的使用。 一组超低视力受试者将执行目标2下开发的任务， Rasch分析将用于为每个任务和参数设置分配难度分数。 4.在有经验的和新的视网膜植入物接受者中使用工具和评分系统。 一组10名视网膜植入者将练习并执行相同的任务;将使用Rasch分析 来检验两个受试者群体之间的潜在差异 5.传播PLoVR核心课程：调查、性能任务、说明和文档 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课程将提供给追求治疗方式的研究联盟， 先进的眼科疾病，作为一套统一的标准，以证明临床和功能的有效性。