title: Assessment of visual performance in the evaluation of new medical products.
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.:
authors: 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. Electronic address:bruce.drum@fda.hhs.gov.
authors: B
authors: B
authors: Drum
authors: 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.
authors: D
authors: D
authors: Calogero
authors: 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.
authors: E
authors: E
authors: Rorer