Clinical Trial Consultant, Atlanta, GA 30307, USA.
Eye Contact Lens. 2013 Jan;39(1):109-14. doi: 10.1097/ICL.0b013e31827c9939.
This is an overview of the US contact lens (CL) postmarket surveillance systems and surveillance study results that include silicone hydrogel CLs. As 30-night continuous wear silicone hydrogel and rigid gas-permeable (RGP) CLs were approved for use in the United States in 2001, the Food and Drug Administration (FDA) mandated large postmarket surveillance studies to assess the risk of microbial keratitis with those products when worn with the 30-night wearing schedule. Since the time of the approvals, RGP 30-night wear has been used sparingly and a shift from 30-night wear has occurred for silicone hydrogel lenses. Several silicone hydrogel lenses have been approved and most of these lenses are being prescribed for daily or flexible wear and not for 30-night wear. With daily wear and less overnight use, silicone hydrogel lenses are regularly exposed to lens care products, lens cases, and improper handling, all of which may introduce sources of microbial contamination that could trigger lens-related complications. This summary of CL postmarket surveillance system and methods gives results of FDA-mandated surveillance and of recent US studies that observed "real-world" populations for safety results outside the bounds of highly controlled prospective clinical trials.
这是对美国隐形眼镜（CL）上市后监测系统和监测研究结果的概述，其中包括硅水凝胶隐形眼镜。由于 30 夜连续佩戴的硅水凝胶隐形眼镜和硬性透气性隐形眼镜（RGP）于 2001 年在美国获得批准使用，美国食品和药物管理局（FDA）强制要求进行大型上市后监测研究，以评估这些产品在按照 30 夜佩戴时间表佩戴时发生微生物角膜炎的风险。自批准以来，RGP 30 夜佩戴的使用已变得稀少，硅水凝胶隐形眼镜的佩戴方式已经发生转变。已经批准了几种硅水凝胶隐形眼镜，其中大多数都被规定为日常或弹性佩戴，而不是 30 夜佩戴。随着日常佩戴和夜间使用减少，硅水凝胶隐形眼镜经常接触隐形眼镜护理产品、隐形眼镜盒和不当操作，所有这些都可能引入微生物污染的来源，从而引发与隐形眼镜相关的并发症。本隐形眼镜上市后监测系统和方法概述介绍了 FDA 强制要求的监测结果以及美国最近的研究结果，这些研究观察了“真实世界”人群在高度控制的前瞻性临床试验范围之外的安全性结果。
