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关于使用便携式周边测量加速眼临床试验的可行性

  • 0Department of Optometry and Visual Sciences, School of Health & Medical Sciences, City St George's, University of London, London, England, EC1V 0HB; Save Sight Institute, University of Sydney, Camperdown, NSW, Australia; Prince of Wales hospital eye clinic, High Street, Level 4, The Prince of Wales Hospital, High Street Building, Randwick, NSW, 2031, Australia.
Ophthalmology. Glaucoma +

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2025年八月27日

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2025年八月27日

在PubMed上查看摘要

概括

此摘要是机器生成的。

家庭视觉现场测试可以比标准方法更快地检测青光眼的进展, 即使使用不太可靠的设备. 使用便携式周边测试的测试频率增加可能会减少临床试验样本大小.

科学领域

  • 眼科 眼科
  • 临床试验
  • 医疗器械

背景情况

  • 通常使用临床视野 (VF) 测试来监测青光眼的进展.
  • 便携式,基于家庭的周边测量为更频繁的监测提供了潜力.
  • 在临床试验设计中,评估家庭周边测试在检测青光眼进展方面的有用性至关重要.

研究的目的

  • 在临床试验环境中,频繁 (每周,每月) 进行家庭视野评估以检测青光眼进展的有效性.
  • 为了比较便携式周边测量与诊所标准设备的性能,以检测青光眼的进展.
  • 评估家庭周边对临床试验样本大小要求的影响.

主要方法

  • 这是一项涉及40名患者 (78只眼睛) 具有不同眼病状况的横截面模拟研究.
  • 参与者接受了便携式 (Eyecatcher v3.0; EC3) 和参考 (HFA SITA-Fast) 视觉现场测试.
  • 用线性混合模型预测不同测试频率和变化水平下检测到的进展者的比例.

主要成果

  • 与参考装置 (HFA;4.25dB) 相比,便携式周边仪 (EC3) 的可靠性较低 (CoRMD95%=6.37dB).
  • 模拟表明,每月EC3检测可以检测出比每季度HFA检测更高比例的进展者.
  • 频繁的家庭检测 (每月/每两周一次) 可以使临床试验所需的样本大小减少24.3%/36.3%,从而检测出20%的进展.

结论

  • 尽管设备的可靠性较低,但家庭视野评估通过增加测试频率可以更快更好地检测青光眼的进展.
  • 在临床试验中使用家庭周边测量可能会显著减少所需的参与者数量.
  • 需要进一步考虑在家监测眼的持续时间,获取和成本效益.

关键词:

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