自动非接触性声度计的临床评估:与戈德曼平面化声度计的可互换性和可重复性
Michael Chaglasian1, Huiyuan Hou2, Mayra Tafreshi2
1Illinois College of Optometry, Chicago, IL 60616, USA.
Journal of clinical medicine
|April 26, 2025
概括
在TRK-3 OMNIA非接触式度仪 (NCT) 显示强烈的协议和统计等效与戈德曼平面度仪 (GAT) 眼内压力 (IOP) 测量. 这种自动化度仪提供可靠和可重复的IOP读数,支持其在临床实践中的使用.
科学领域:
- 眼科医生 眼科 眼科
- 眼镜测量是指眼睛的测量.
- 生物医学工程 生物医学工程
背景情况:
- 准确的眼内压力 (IOP) 测量对于诊断和治疗青光眼至关重要.
- 戈尔德曼平面度仪 (GAT) 是黄金标准,但非接触式度仪 (NCT) 提供了方便.
- 评估新的NCT器件的临床可互换性和可重复性至关重要.
研究的目的:
- 评估TRK-3 OMNIA NCT和戈德曼平面度计 (GAT) 之间的眼内压 (IOP) 测量的临床可互换性.
- 评估使用TRK-3 OMNIA获得的IOP测量的可重复性.
- 为了确定不同IOP范围之间的相关性和一致性.
主要方法:
- 基于GAT的前性多中心研究,涉及120名受试者,分为低,中,高IOP组.
- 使用TRK-3 OMNIA和GAT采用标准化协议进行IOP测量.
- 统计分析包括布兰德-阿尔特曼分析,同等性测试 (TOST) 和线性回归;通过ICC评估的重复性,重复性极限和CV.
主要成果:
- TRK-3 OMNIA和GAT之间的平均差异为-0.2 mmHg,具有很强的相关性 (r=0.92).
- 在所有 IOP 组中证实了统计学等价性,尽管在低 IOP 区间中略有高估,而在高 IOP 区间中略有低估.
- TRK-3 OMNIA表现出良好的重复性 (ICC=0.94,CV=5.65%),重复性极限因IOP组而异.
结论:
- TRK-3 OMNIA 度仪显示强烈的一致性,统计等价性和高相关性与 GAT,支持临床可互换性.
- 该设备具有很高的重复性,表明IOP测量的可靠性.
- TRK-3 OMNIA是常规临床工作流程的合适工具,提供可靠的IOP评估.
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