与植入式膜透镜相关的不良事件:来自FDA MAUDE数据库的见解
Qing Chen1, Haijing Yan1, Letong Chen1
1National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, China.
Frontiers in medicine
|August 5, 2025
概括
植入式粘合镜 (ICL) 的不良反应不常见,但与尺寸和非标签使用有关. 改善ICL大小和遵循指南可以减少并发症.
科学领域:
- 眼科医生 眼科 眼科
- 医疗设备分析 医疗设备分析
- 外科手术的结果
背景情况:
- 植入式粘合镜 (ICL) 程序在全球越来越普遍.
- 关于ICL相关不良事件 (AE) 的现实数据有限.
- 了解ICL并发症对于患者安全和外科手术改进至关重要.
研究的目的:
- 使用MAUDE数据库分析ICL相关的并发症和不良事件.
- 识别设备相关问题和手术并发症的趋势.
- 评估ICL并发症的管理策略和解决率.
主要方法:
- 从MAUDE数据库中提取了ICL不良事件数据.
- 将病例分为球形ICL和形ICL.
- 利用描述性统计和克拉梅尔的V来评估并发症和ICL类型之间的关联.
- 评估的管理策略和解决率.
主要成果:
- 分析了25001个ICL相关的AE;56.2%涉及性ICL.
- "形状和/或尺寸问题"和"非标签使用"是与设备相关的重大问题.
- 最常见的并发症包括"视力问题"",眼内压力问题"和"与镜头有关的问题",大多没有对患者产生影响.
- 在球体ICL和骨ICL中发现并发症和副作用之间的中等相关性.
结论:
- 虽然ICL植入通常是安全的,但仍然存在对镜片大小和非标签使用的担忧.
- 提高镜片尺寸的准确性和遵守外科指南可能会最大限度地减少ICL相关的AE.
- 对于ICL并发症存在有效的管理策略,报告了高的解决率.
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