为开发用于白内障手术的单聚焦眼内透镜的核心结果集进行系统审查
Rosanna Tarricone1,2, Carla Rognoni1, Anita Ciarlo1
1Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, Italy.
Frontiers in medicine
|March 6, 2024
概括
在白内障手术后开发了一种新的核心结果集 (COS) 来评估新的单焦眼内透镜 (IOLs). 该COS包括患者报告的结果和临床措施,以评估视觉功能和生活质量.
科学领域:
- 眼科医生 眼科 眼科
- 医疗器械 医疗器械
- 临床试验 临床试验
背景情况:
- 白内障手术使用单焦眼内透镜 (IOL) 来纠正视力.
- 眼镜技术的进步导致了新一代单焦眼镜,具有增强的视觉能力.
- 现有的核心结果集 (COS) 可能无法完全捕捉这些新 IOL 的好处.
研究的目的:
- 定义一个全面的核心结果集 (COS),用于在白内障手术后对单焦眼内透镜 (IOL) 的术后评估.
- 通过考虑新一代单焦内膜眼镜来更新现有的COS,提供扩展的中间视力.
- 将临床和以患者为中心的结果纳入整体评估.
主要方法:
- 一个系统的文献搜索确定了观察性研究和随机对照试验 (RCT) 的相关结果.
- 混合方法结合了Delphi驱动的方法和专家小组,吸引了眼科医生来选择临床结果.
- 患者通过问卷参与,以确定视觉功能和生活质量的关键方面.
主要成果:
- 建立了一个最终的COS,包括15个结果,包括11个临床结果 (视觉敏度,对比度敏感性,折射误差,偏差,不良事件).
- 患者的优先事项包括生活质量,近视活动,眼镜独立性和中间视力安全性.
- 定义了具体的指标,聚合方法和测量结果的时间点.
结论:
- 开发的COS提供了一个最新的框架,用于评估白内障手术后的单焦内膜眼镜.
- 纳入患者偏好确保COS反映了对日常活动和生活质量的现实影响.
- 这种COS可以在临床试验和实践中使用,以产生关于IOL性能的真实证据.
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