Ruiz-Lozano Raul E, Quiroga-Garza Manuel E, Ramos-Dávila Eugenia M, Pantaleón-García Jezreel, Khodor Ali, Komai Seitaro, Rodriguez-Gutierrez Luis A, Ma Symon, Mousa Hazem M, Mattes Robby, Stinnett Sandra S, Sabater Alfonso L, Perez Victor L
From the Bascom Palmer Eye Institute, University of Miami, Miami, Florida, USA; Tecnologico de Monterrey, School of Medicine and Health Sciences, Institute of Ophthalmology and Visual Sciences, Monterrey, Mexico.
From the Bascom Palmer Eye Institute, University of Miami, Miami, Florida, USA.
Am J Ophthalmol. 2025 Mar;271:407-416. doi: 10.1016/j.ajo.2024.12.013. Epub 2024 Dec 17.
Primarily, to evaluate the repeatability and reproducibility of the new noncontact esthesiometer (NCE) in healthy subjects. Secondarily, the corneal sensitivity threshold measurements of the NCE were compared with those of the Cochet-Bonnet esthesiometer (CBE).
Assessment reliability study.
Two examiners measured bilateral corneal sensitivity thresholds by NCE and CBE. Triple NCE measurements were performed per eye at all 5 levels, whereas single CBE measurements were performed per eye. When appropriate, NCE (mBar) and CBE (mm) measurements were converted to millinewtons (mN) for direct comparison between devices. The NCE measurement variations were calculated with the intra-class correlation coefficients (ICC) for the primary objective. For the secondary objective, Bland-Altman plots with 95% limits of agreement (95%-LoA) and Spearman's rank correlation coefficients were used to evaluate the level of agreement and linear relationship between the corneal sensitivity thresholds obtained with both devices. Generalized estimating equation models were used to account for the inter-eye correlation of the same study participant.
Fifty subjects (100 eyes) aged 29 years (median) were included. There were no statistically significant differences in the pressure measured by both observers at each NCE level (all P > .05). There was a high intra-observer and inter-observer repeatability of the NCE measurements (ICC > 0.90) and a strong linear correlation (rho > 0.7) at each NCE level. The difference between the mean corneal sensitivity thresholds (mN) measured with the NCE (0.052 ± 0.021 mN) and CBE (0.046 ± 0.005 mN) was statistically significant (P = .001). Bland-Altman analysis revealed a differential bias of +0.00578 mN (95%-LoA -0.03677 - +0.04833 mN) between threshold measurements.
The NCE provides reliable user-independent corneal sensitivity measurements. The NCE and CBE do not yield similar values. Thus, both devices cannot be used interchangeably.
主要评估新型非接触式感觉计(NCE)在健康受试者中的重复性和再现性。其次,比较NCE与科谢-博内感觉计(CBE)的角膜敏感度阈值测量结果。
评估可靠性研究。
两名检查者使用NCE和CBE测量双侧角膜敏感度阈值。每只眼睛在所有5个水平上进行3次NCE测量,而每只眼睛进行1次CBE测量。在适当的时候,将NCE(毫巴)和CBE(毫米)测量值转换为毫牛顿(mN),以便在两种设备之间进行直接比较。使用组内相关系数(ICC)计算NCE测量的变化,以实现主要目标。对于次要目标,使用具有95%一致性界限(95%-LoA)的布兰德-奥特曼图和斯皮尔曼等级相关系数来评估两种设备获得的角膜敏感度阈值之间的一致性水平和线性关系。使用广义估计方程模型来考虑同一研究参与者两眼之间的相关性。
纳入了50名年龄中位数为29岁的受试者(100只眼睛)。在每个NCE水平上,两名观察者测量的压力没有统计学上的显著差异(所有P>.05)。NCE测量具有较高的观察者内和观察者间重复性(ICC>0.90),并且在每个NCE水平上具有很强的线性相关性(rho>0.7)。使用NCE(0.052±0.021 mN)和CBE(0.046±0.005 mN)测量的平均角膜敏感度阈值之间的差异具有统计学意义(P=.001)。布兰德-奥特曼分析显示,阈值测量之间的差异偏差为+0.00578 mN(95%-LoA为-0.03677至+0.04833 mN)。
NCE提供了可靠的、与用户无关的角膜敏感度测量。NCE和CBE得出的值不相似。因此,两种设备不能互换使用。