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Assessment of visual performance in the evaluation of new medical products
B Drum1, D Calogero1, E Rorer1
1Food 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.
Abstract:
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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