NEI/FDA Endpoints Symposium2011 NEI/FDA Functional Vision Assessment for Visual Prostheses Clinical TrialsFriday, May 6, 2011Masur Auditorium, National Institutes of Health, Bethesda, MD
Newswise — Bethesda, MD — The National Eye Institute (NEI) and Food and Drug Administration (FDA) are sponsoring a conference to determine how functional vision-related endpoints for clinical trials of visual prostheses will be analyzed and correlated with objective measures of visual acuity, visual fields and contrast sensitivity. These assessments may provide valuable information that will corroborate standard clinical test outcomes.
Today, functional vision outcomes — such as how patients perform orientation and mobility tasks and other daily living activities — are being incorporated more frequently into randomized clinical trials.
A growing body of evidence strongly suggests that functional vision data may provide a better understanding of what patients can actually do beyond the data obtained from visual acuity or visual field measurements. The FDA is already incorporating this type of clinical data into guidance for clinical trials of investigational visual prostheses.
Agenda highlights
‧ Differentiate between functional vision and visual function ‧ Provide an overview of guidance documents relevant to visual prostheses ‧ Identify critical elements in orientation and mobility assessments as they relate to retinal implants ‧ Identify critical elements of activities in daily living assessment necessary to establish effectiveness of retinal implants to improve visual function ‧ Interactive/open discussion with leaders in the field of vision rehabilitation and visual prostheses regarding next steps This meeting, part of an NEI/FDA series of Endpoints Symposia, will explore the issues and challenges related to functional vision information in ophthalmology. Participants will also look at FDA guidelines for using functional vision outcomes and how they are incorporated for the investigation and labeling of medical devices and drugs.
Faculty will include authorities in vision rehabilitation, orientation and mobility, occupational therapy, ophthalmology and optometry. FDA representatives will present insights about how the FDA reviews and evaluates functional vision outcomes in support of product labeling for visual prostheses and drugs used for the treatment of retinal diseases.
The goal of this meeting is to obtain recommendations for measuring specific tasks of mobility and daily living activities as well as how they will be analyzed and correlated with objective measures of visual acuity and contrast sensitivity in the clinical trial.
Who should attend?
‧ clinical researchers/basic scientists in the visual prostheses field ‧ retina specialists ‧ clinical trialists ‧ pharmaceutical company representatives ‧ device company representatives ‧ other biotechnology companies in the field of retinal stem cell implants ‧ Low vision/vision rehabilitation researchers ‧ Daily living activities researchers
Visit www.arvo.org/endpoints to download the full agenda, including faculty, and to register. This meeting is managed by the Association for Research in Vision and Ophthalmology.
The Association for Research in Vision and Ophthalmology (ARVO) is the largest eye and vision research organization in the world. Members include more than 12,500 eye and vision researchers from over 80 countries. ARVO encourages and assists research, training, publication and knowledge-sharing in vision and ophthalmology. Visit www.arvo.org.
The National Eye Institute (NEI), a component of the National Institutes of Health, is the federal government's lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness. For more information, visit the NEI website at www.nei.nih.gov.
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