脊椎微绕道微创视眼镜外科手术设备的不良反应:来自FDA MAUDE数据库的五年分析
Yousef Hawas1, Alina Ghazou2, Martin W Gerges1
1Faculty of Medicine, Tanta University, Tanta, Egypt.
International ophthalmology
|November 18, 2025
概括
像Hydrus®和iStent®这样的微侵袭性玻璃眼外科手术 (MIGS) 设备通常显示出良好的安全性. 市场后监测显示,经常出现错位和机械故障的报告,强调需要进一步的真实数据.
科学领域:
- 眼科医生 眼科 眼科
- 医疗器械安全 医疗器械安全
- 视光眼管理 视光眼管理
背景情况:
- 全球有数以百万计的人患有青光眼,预计这一数字将大幅上升.
- 最少侵入性玻璃眼外科手术 (MIGS) 通过增强水性幽默排水,为开角玻璃眼提供了有效的治疗方法.
- MIGS器件的长期安全性和有效性需要在不同患者群体中进行持续的市场后监测.
研究的目的:
- 在五年内分析Hydrus® Microstent和iStent®状微旁路MIGS器件的不良事件.
- 使用FDA MAUDE数据库报告来描述与设备和患者相关的并发症.
- 确定MIGS设备在绿眼病管理中的真实安全概况.
主要方法:
- 对2020年1月至2024年10月的FDA MAUDE数据库报告进行了回顾性案例系列分析.
- 使用产品代码"OGO" (Hydrus®) 和"KYF" (iStent®) 的报告进行选.
- 分析了784份符合资格报告的设备和患者相关不良事件报告,并提供描述性统计数据和可视化.
主要成果:
- 在784例病例中报告了受伤 (63.1%) 和故障 (36.9%).
- 常见的设备相关问题包括错位 (37.3%) 和断裂 (23.5%).
- 常见的患者相关事件是眼内压力 (IOP) 升高 (19.4%) 和缺血症 (12.1%).
结论:
- 在上市后的监测中,Hydrus®和iStent®带微绕道MIGS设备的安全性通常是有利的.
- 经常报告设备的错位和机械故障,但实际情况需要进一步调查.
- 研究结果支持改善外科培训,患者咨询,并强调需要有潜在的注册机构来确定真正的并发症率.
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