表13_植入式Collamer晶状体相关不良事件：基于FDA MAUDE数据库的见解
基于FDA MAUDE数据库的ICL相关不良事件分析表，涵盖球形与环曲面ICL的器械问题、并发症及管理策略。
基本信息
资源简介
表13_植入式Collamer晶状体相关不良事件：基于FDA MAUDE数据库的见解
【一句话概览】
本数据集是 figshare 公开的结构化表格数据集，收录 1 个文件、合计 49.18 KB，主题涵盖 FDA MAUDE database、adverse events、toric Implantable Collamer Lens、retrospective analysis、spherical Implantable Collamer Lens，可用于统计建模、特征工程与队列分析，CC BY 4.0 许可开放获取。
【数据集背景】
本数据集源站标题为《Table 13_Adverse events associated with Implantable Collamer Lens: insights from the FDA MAUDE database.xlsx》。配套论文《Adverse events associated with femtosecond laser–assisted cataract surgery reported to the MAUDE database》发表于 Journal of Cataract & Refractive Surgery（2022），DOI：10.1097/j.jcrs.0000000000000739。源站首次发布：2025-07-21。
【数据内容】
源站原始描述：PurposeImplantable Collamer Lens (ICL) implantation is rising globally, yet real-world studies on adverse events (AEs) remain scarce. This study analyses ICL-related complications using the MAUDE database. MethodsData on ICL-related AEs were extracted from the MAUDE database. Cases were categorized into spherical and toric ICLs based on lens diopter. Descriptive statistics summarized device-related issues and complications, and Cramér’s V assessed their associations. Management strategies and re…
【数据结构与技术规格】
文件数 1 个，合计 49.18 KB。Table 13_Adverse events associated with Implantable Collamer Lens: insights from the FDA MAUDE database.xlsx：application/vnd.openxmlformats-officedocument.spreadsheetml.sheet，49.18 KB。数据集 DOI：10.3389/fmed.2025.1613060.s014。
【主题与分类】
源站学科分类：Foetal Development and Medicine。主题标签：FDA MAUDE database、adverse events、toric Implantable Collamer Lens、retrospective analysis、spherical Implantable Collamer Lens。
【适用方向】
结构化表格数据可直接用于统计建模、特征工程与队列分析。
【获取与许可】
源站页面：https://frontiersin.figshare.com/articles/dataset/Table_13_Adverse_events_associated_with_Implantable_Collamer_Lens_insights_from_the_FDA_MAUDE_database_xlsx/29607617
使用许可：CC BY 4.0（https://creativecommons.org/licenses/by/4.0/）。
规范引用：Chen, Qing; Yan, Haijing; Chen, Letong; Wang, Limei; Zheng, Qinxiang; Ren, Yueping (2025). Table 13_Adverse events associated with Implantable Collamer Lens: insights from the FDA MAUDE database.xlsx. Frontiers. Dataset
下载信息
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使用方式
数据集获取（Figshare）
- 源站标题：Table 13_Adverse events associated with Implantable Collamer Lens: insights from the FDA MAUDE database.xlsx
- DOI：10.3389/fmed.2025.1613060.s014
- 发布日期：2025-07-21
- 文件数：1 个
- 文件总体积：49.18 KB
- 源站页面：https://frontiersin.figshare.com/articles/dataset/Table_13_Adverse_events_associated_with_Implantable_Collamer_Lens_insights_from_the_FDA_MAUDE_database_xlsx/29607617
命令行下载
curl -L -o "Table 13_Adverse events associated with Implantable Collamer Lens: insights from the FDA MAUDE database.xlsx" "https://ndownloader.figshare.com/files/56416016"
文件清单
Table 13_Adverse events associated with Implantable Collamer Lens: insights from the FDA MAUDE database.xlsx（49.18 KB）
文件总体积 49.18 KB（源站 API 实测）。
数据说明
PurposeImplantable Collamer Lens (ICL) implantation is rising globally, yet real-world studies on adverse events (AEs) remain scarce. This study analyses ICL-related complications using the MAUDE database.
MethodsData on ICL-related AEs were extracted from the MAUDE database. Cases were categorized into spherical and toric ICLs based on lens diopter. Descriptive statistics summarized device-related issues and complications, and Cramér’s V assessed their associations. Management strategies and resolution rates for common complications were also evaluated.
ResultsAmong 25,001 ICL-related AEs, 43.8% involved spherical ICLs and 56.2% toric ICLs. Common device-related issues included “Shape and/or size problems” (nearly half of annual AEs) and “Off-label use” (around 20%, rising since 2019 and stabilizing). “Operation and control issues” declined steadily since 2019, stabilizing below 3%. Spherical ICL cases with “Activation, positioning, or separation problems” dropped below 1% post-2019, while toric cases remained at 6.9–9.0%. The top three complications—"Vision issues,” “Intraocular pressure issues” and “Lens-related issues”—were most frequent, with “No patient impact” in most cases. Moderate correlations were found between complications and ICL-related AEs (p = 9.999 × 10−5, Cramér’s V: 0.47 for spherical, 0.45 for toric). Management strategies, including lens exchange and lens extraction followed by surgery, demonstrated high resolution rates.
ConclusionWhile ICL implantation is generally safe, concerns about inappropriate sizing and off-label use persist. This study suggests that improving lens sizing accuracy and adhering to guidelines may reduce AEs.
许可
CC BY 4.0
引用
学术使用请引用 DOI 10.3389/fmed.2025.1613060.s014（source: https://frontiersin.figshare.com/articles/dataset/Table_13_Adverse_events_associated_with_Implantable_Collamer_Lens_insights_from_the_FDA_MAUDE_database_xlsx/29607617）。
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