Planning a Clinical Trial on Low Vision Rehabilitation

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DESCRIPTION (provided by applicant): Sound scientific evidence about the effectiveness of low vision rehabilitation services as provided today in the U.S. remains unavailable despite the high prevalence of visual impairment in this country, the widespread availability of services, and increased public awareness about low vision. Information about the effectiveness of these services is needed in order to: (1) Provide an evidence-base demonstrating the effectiveness of low vision services on vision-targeted health-related quality of life and performance of visual tasks so clients are offered realistic information about potential personal benefits. (2) Provide information about what types or levels of services have effectiveness on vision-targeted health-related quality of life and performance of visual tasks. (3) Provide information that could assist the Center for Medicare and Medicaid Services (CMS) in formulating policy on coverage of these services. The long-term goal of this program of research is to conduct a randomized clinical trial on the effectiveness of low vision rehabilitation services as they are carried out in the U.S. for adult clients who seek them. Before such a randomized clinical trial can be reasonably designed, there are several issues that first must be addressed. This Planning Grant affords us a mechanism by which we can carry out these essential preliminary activities. The specific aims of this planning phase are to answer these questions. (1) What is usual care? How should the low vision rehabilitation services available to adults in the U.S. be characterized? What is the range of services offered? (2) Is a recently developed vision-targeted health related quality of life questionnaire responsive to low vision rehabilitation? (3) What are valid, reliable, and responsive visual performance task measurements that could be used as outcome measures in the clinical trial? (4) Using this information, we will design a multi-center randomized clinical trial for submission to the National Eye Institute, develop a manual of procedures, and design an electronic database.