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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Use of Functional Vision Endpoints in Visual Prostheses Product Development

Friday, May 6, 2011
Building 10, Masur Auditorium
National Institutes of Health
Bethesda, Maryland

The National Eye Institute (NEI) and the Food and Drug Administration (FDA) are sponsoring a one-day conference to examine how both functional and objective endpoints can be used in clinical trials of visual prostheses. The discussions will determine how daily living activities, such as mobility, can 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.

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 to download the full agenda, including faculty, and to register. This meeting is managed by the Association for Research in Vision and Ophthalmology (ARVO). 

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Presentation

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