Assessment of visual performance in the evaluation of new medical products.

Drug Discov Today Technol

Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Ophthalmic and ENT Devices, 9200 Corporate Boulevard, Rockville, MD 20850, USA.

Published: July 2014

When evaluating how a medical product affects vision, it is important to assess how that product affects the ability to function in real life, not only the ability to read letters on a vision chart. Nevertheless, the measurement of visual acuity with a vision chart remains the primary test of the effects of medical products on vision. Here, we review efforts to identify reliable, cost-effective clinical tests to serve as surrogate measures of functional visual performance.:

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http://dx.doi.org/10.1016/j.ddtec.2007.10.009DOI Listing

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