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

描述（由申请人提供）：全世界约有18个小组正在研究视网膜植入物，至少有5个小组已经进行了急性测试，目前至少有一个联盟正在进行临床评估，明年还有另外3个联盟正在进行临床评估。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接受者，主要是为了响应其自身的需求和FDA的要求，以量化和记录假体功能和患者表现。一些程序是在SSMP中开发的，而另一些程序则是建立在低视力康复、视觉假体试验、临床前视觉假体研究和假体视觉模拟中开发的现有测试和培训材料的基础上。然而，虽然未来的康复课程的组成部分确实存在，没有综合的方法，假肢低视力康复已制定。拟议计划的直接目标是将超低视力的评估和康复工具整合，完善和创建到一个计划中，该计划将为电子视觉修复领域的研究和临床团队提供培训，跟踪和评估植入患者的方法，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，沿着手册和在线课程材料，将形成一个假体低视力康复（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扩大到超低视力。视力极其有限的患者人群将创建一个活动“库”，并要求根据难度对这些活动进行排名;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使用的工具（视觉信息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根据目标2开发的任务，用于多个参数设置; Rasch分析将用于为每个任务和参数设置分配难度评分。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名视网膜植入物配戴者将练习并执行相同的任务; Rasch分析将用于检查两个受试者组之间的潜在差异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课程将提供给追求晚期眼病治疗方式的研究联盟，作为一套统一的标准来证明临床和功能有效性。 公共卫生相关性：用于恢复因视网膜疾病而失明的患者视力的电子植入物目前处于早期临床试验阶段，可能很快就会用于更广泛的临床研究。这种植入物不会提供良好的视力，但即使是最低的视力水平也可以为现在功能性失明的患者提供独立性。目前很少有工具可用于培训患者使用如此低水平的视力，或测量这些植入物的有效性。拟议的研究将开发这些工具，以及培训研究人员和康复专家使用这些工具的指导材料。

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. PUBLIC HEALTH RELEVANCE: Electronic implants to restore vision in patients blind from retinal disease are currently in early-stage clinical trials and may soon become available for wider clinical studies. Such implants will not provide good vision, but even minimal vision levels can make provide independence to patients who are now functionally blind. Very few tools are currently available to train patients in the use of vision at such very low levels, or to measure the effectiveness of these implants. The proposed study will develop such tools, and the instruction materials to train researchers and rehabilitation specialists in their use.