Assessment of visual performance in the evaluation of new medical products

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.

Section editor:Janet Woodcock – Food and Drug Administration, Rockville, MD, USA