角膜塑形镜安全风险分析与应用监管的探讨

Safety risk analysis and application supervision of orthokeratology

摘要:

目的 为促进角膜塑形镜安全使用，强化角膜塑形镜应用监管提供参考。方法 通过研究国内外文献，了解角膜塑形镜的应用现状，结合日常监测实际，分析影响角膜塑形镜安全使用的影响因素，提出应用管理建议。结果 从角膜塑形镜设计风险、质量风险和临床使用风险入手，发现角膜塑形镜的设计结构、材质与质量、生产工艺、验配情况、日常使用以及护理液的材质等均可能会导致不良事件的发生，针对监管机构、注册人、验配机构、使用人群提出系列建议。结论 角膜塑形镜安全使用监管应贯穿产品的生产，验配及使用全过程。

Abstract:

Objective To promote the safe use of orthokeratology lenses and enhance regulatory guidance for their application.Methods Through a review of domestic and foreign literature, understanding the current status of orthokeratology lenses application, and combining daily monitoring experience, we analyzed the influencing factors affecting the safe use of orthokeratology lenses and proposed application management recommendations.Results Starting from the design risks, quality risks, and clinical usage risks of orthokeratology lenses, factors such as the design structure, material and quality, manufacturing processes, fitting conditions, daily usage, and the material of care solutions may lead to adverse events. A series of recommendations are put forward for regulatory agencies, registrants, fitting institutions, and user groups.Conclusion Regulatory oversight for the safe use of orthokeratology lenses should span the entire process from product fitting to usage.