新医疗产品评估中的视觉性能评估
Assessment of visual performance in the evaluation of new medical products.
作者信息
Drum B, Calogero D, Rorer E
机构信息
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.
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.
出版信息
Drug Discov Today Technol. 2007 Winter;4(2):55-61. doi: 10.1016/j.ddtec.2007.10.009.
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.:
在评估一种医疗产品如何影响视力时，重要的是评估该产品如何影响在现实生活中的功能能力，而不仅仅是在视力表上识别字母的能力。然而，使用视力表测量视力仍然是医疗产品对视力影响的主要测试。在此，我们回顾了为确定可靠、具有成本效益的临床试验以作为功能性视觉表现替代指标所做的努力。
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