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两种共聚焦激光角膜显微镜设备(Tomey EM-4000 和 Nidek CEM-530)在实际应用中的设备内重复性和设备间比较。

Intradevice Repeatability and Interdevice Comparison of Two Specular Microscopy Devices in a Real-Life Setting: Tomey EM-4000 and Nidek CEM-530.

机构信息

Department of Ophthalmology, University of Geneva, 1205 Geneva, Switzerland.

Experimental Ophthalmology, University of Geneva, 1205 Geneva, Switzerland.

出版信息

Medicina (Kaunas). 2024 Jul 9;60(7):1110. doi: 10.3390/medicina60071110.

Abstract

: The purpose of this study was to compare two commercially available specular microscopes (Tomey EM-4000 and Nidek CEM-530) in a real-life clinical setting in terms of intra- and interdevice variability. The study was conducted on all patients seen in a clinical practice specializing in anterior segment pathologies, regardless of the purpose of their visit. : In total, 112 eyes of 56 patients (age 23-85 years old) were included in the study. Each eye was measured three times with each device (for a total of six measurements), and results for central corneal thickness (CCT) and corneal endothelial cell density (ECD) were recorded. The results were then evaluated with the D'Agostino-Pearson normality test and compared with a Wilcoxon signed-rank test, -test, ANOVA or Mann-Whitney test for intra- and interdevice variability. : Both specular microscopes produced very reliable reproducible intradevice results: The Tomey EM-4000 measured an ECD of 2390 ± 49.57 cells/mm (mean ± standard error of mean); the range was 799-3010 cells/mm. The determined CCT was 546 ± 5.104 µm (mean ± standard error of mean [SEM]); the range was 425-615 µm. The measurements with the Nidek CEM-530 revealed an ECD of 2417 ± 0.09 cells/mm (mean ± SEM); the range was 505-3461 cells/mm (mean ± SEM). The mean CCT detected was 546.3 ± 4.937 µm (mean ± SEM); the range was 431-621 µm. The interdevice differences were statistically significant for both parameters, ECD ( = 0.0175) and CCT ( = 0.0125) ( < 0.05). : The Nidek CEM-530 and the Tomey EM-4000 both produced reliable and reproducible results in terms of ECD and CCT. The absolute measurements were statistically significantly different for CCT and ECD for both devices; the Nidek produces slightly higher values.

摘要

本研究旨在比较两种市售共焦显微镜(Tomey EM-4000 和 Nidek CEM-530)在实际临床环境中的内在和设备间变异性。该研究在一家专门从事眼前段病变的临床实践中对所有患者进行,无论其就诊目的如何。

共有 56 名患者(年龄 23-85 岁)的 112 只眼纳入本研究。每只眼用每种仪器测量 3 次(共 6 次测量),并记录中央角膜厚度(CCT)和角膜内皮细胞密度(ECD)的结果。然后使用 D'Agostino-Pearson 正态性检验对结果进行评估,并与 Wilcoxon 符号秩检验、t 检验、方差分析或 Mann-Whitney 检验进行内在和设备间变异性的比较。

两种共焦显微镜均产生非常可靠的重复性设备内结果

Tomey EM-4000 测量的 ECD 为 2390±49.57 个细胞/mm²(平均值±标准误差);范围为 799-3010 个细胞/mm²。确定的 CCT 为 546±5.104 µm(平均值±标准误差[SEM]);范围为 425-615 µm。使用 Nidek CEM-530 进行的测量显示 ECD 为 2417±0.09 个细胞/mm²(平均值±SEM);范围为 505-3461 个细胞/mm²(平均值±SEM)。检测到的平均 CCT 为 546.3±4.937 µm(平均值±SEM);范围为 431-621 µm。ECD(=0.0175)和 CCT(=0.0125)这两个参数的设备间差异均具有统计学意义(<0.05)。

Nidek CEM-530 和 Tomey EM-4000 在 ECD 和 CCT 方面均产生可靠且可重复的结果。两种设备的 CCT 和 ECD 的绝对测量值均存在统计学差异;Nidek 产生的数值略高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d18f/11278872/cc6c50860319/medicina-60-01110-g001.jpg

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