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临床验证M-TONX:一种新的复合反弹音标仪和心智仪

Naveed Nilforushan¹, Mozafar Yousefi², Ankica Babic^3,4

¹Eye Research Centre, Iran University of Medical Sciences, Tehran, Iran.

Translational vision science & technology

|December 26, 2024

概括

M-TONX设备可同时可靠地测量眼内压力 (IOP) 和中角膜厚度 (CCT). 它的准确性在广泛的测量中保持稳定,证实了其临床实用性.

科学领域:

眼科医生眼科眼科
生物医学工程生物医学工程
医疗器械医疗器械

背景情况:

精确测量眼内压力 (IOP) 和中角膜厚度 (CCT) 对于诊断和管理青光眼和其他眼部疾病至关重要.
目前的方法通常需要单独的设备,增加检查时间和复杂性.
该M-TONX设备使用创新的反弹技术同时进行IOP和CCT测量.

研究的目的:

临床研究M-TONX设备的性能,用于同时测量IOP和CCT.
为了将M-TONX测量与既定标准设备进行比较,例如高盛平面化音量计 (GAT) 和Pentacam角膜拓仪.
评估M-TONX在不同IOP和CCT范围内的准确性和可靠性.

主要方法:

使用M-TONX设备测量了225名受试者的374只眼睛的内视力和CCT.
用高盛平面化度仪 (GAT) 和Pentacam角膜拓仪作为黄金标准重复测量.
统计分析涉及基于IOP (<=16,16-23,>=23毫米) 和CCT (<=475,475-574,>=575微米) 的患者分层.

主要成果:

M-TONX与标准设备具有很高的一致性,IOP的置信区间为0.7-1.2mm Hg,CCT的置信区间为-12.7至-5.4μm.
分层分析显示了实质性的一致性,所有组和类的类内相关系数>0.65和皮尔森相关系数>0.8.
该设备在广泛的IOP和CCT值中被证明是准确的.

结论:

该M-TONX设备表现出可靠的性能,与IOP和CCT测量的标准方法相美.
它的准确性在各种IOP和CCT范围内是一致的,表明临床有效性.
M-TONX提供了一个用户友好的,紧的解决方案,将两个基本的眼科测量集成到一个单一的设备中.

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