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

描述（由申请人提供）：视网膜植入物目前正在全球大约18个研究小组进行研究，至少有5个小组进行了急性试验，目前至少有一个小组正在进行临床评估，明年将有另外3个小组进行临床评估。Second Sight Medical Products （SSMP）一直在开发工具，以在其Argus II试验中培训和测试植入物受者，主要是为了响应其自身的需求和FDA对假体功能和患者表现进行量化和记录的要求。有些程序是在SSMP内制定的，而其他程序则是根据低视力康复、视觉假体试验、临床前视觉假体研究和假体视觉模拟方面的现有测试和培训材料制定的。然而，虽然未来康复课程的基石确实存在，但尚未制定出假肢低视力康复的综合方法。拟议项目的直接目标是整合、完善和创建评估和康复超低视力的工具，为电子视觉假肢领域的研究和临床团队提供培训、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。由此产生的培训和评估工具，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扩展到超低视力。一群视力极度受限的患者将创建一个活动“库”，并要求他们根据难度对这些活动进行排序；通过Rasch分析，将创建项目测量的logit量表。2. 为视力最低的人设计和改进实践和评估工具。我们将创建并扩展刺激和评估视觉使用的工具（视觉信息收集和视觉引导表现），并开发评分系统和综合结果。3. 评估在严重和深度视力丧失患者中使用的实践和评估工具。一组超低视力受试者将执行目标2中针对多个参数设置制定的任务；Rasch分析将用于分配每个任务的难度分数和参数设置。4. 在有经验和新的视网膜植入接受者中验证工具和评分系统。一组10名视网膜植入者将练习并执行相同的任务；Rasch分析将用于检查两组受试者之间的潜在差异。传播PLoVR核心课程：调查、绩效任务、指导和文档。我们将创建指导手册、在线课程和面向未来PLoVR课程用户的用户组。PLoVR课程将提供给寻求晚期眼病治疗模式的研究联盟，作为一套统一的标准来证明临床和功能有效性。

DESCRIPTION (provided by applicant): 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.