Friday, May 6, 2011 Building 10, Masur Auditorium National Institutes of Health Bethesda, Maryland The National Eye Institute and the Food and Drug Administration are sponsoring a one-day conference to analyze how both objective and functional endpoints can be used in professional trials of visual prostheses. A growing body of evidence strongly suggests that functional vision information might provide a better understanding of what patients can do beyond the information acquired from visual acuity or aesthetic area dimensions. Participants will also look at FDA guidelines for using functional vision results and how they are included for the investigation and labeling of medical gadgets and drugs. FDA agents will present understandings about just how the FDA testimonials and evaluates functional vision results on behalf of product labeling for aesthetic prostheses and drugs used for the therapy of retinal diseases. Professional researchers/basic scientists in the aesthetic prostheses field; Retina specialists; Clinical trialists; Pharmaceutical firm agents; Device company representatives; Other biotechnology firms in the field of retinal stem cell implants; Low vision/vision rehabilitation researchers; Daily living tasks scientists.
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