不同光学测量设备测量近视眼中央角膜厚度的一致性评估

Comparison of central corneal thickness measured by different devices in myopic patients

目的比较角膜内皮镜SP-1P、IOLMaster 700、Pentacam HR三维眼前节分析诊断系统及RTVue XR-OCT 4种不同设备测量中央角膜厚度(CCT)的差异和一致性。方法采用诊断试验研究方法,连续选取2022年1—5月于武汉爱尔眼科汉阳医院拟行角膜屈光手术的低中度近视患者50例50眼,由同一检查者分别采用角膜内皮镜SP-1P、IOLMaster 700、Pentacam HR和RTVue XR-OCT测量CCT,比较4种仪器测量CCT值的差异;分别采用Pearson线性相关分析和Bland-Altman一致性检验评估各种仪器测量CCT值之间的相关性和一致性。结果角膜内皮镜SP-1P、IOLMaster 700、Pentacam HR和RTVue XR-OCT测得的CCT平均值分别为(522.68±30.08)、(544.06±32.85)、(541.00±31.75)和(528.86±31.60)μm,总体比较差异有统计学意义(F=5.09,P=0.002),其中角膜内皮镜SP-1P测量值低于IOLMaster 700和Pentacam HR,IOLMaster 700测量值高于RTVue XR-OCT,差异均有统计学意义(均P<0.05)。Pearson相关分析显示,角膜内皮镜SP-1P与IOLMaster 700、角膜内皮镜SP-1P与Pentacam HR、角膜内皮镜SP-1P与RTVue XR-OCT、IOLMaster 700与Pentacam HR、IOLMaster 700与RTVue XR-OCT、Pentacam HR与RTVue XR-OCT测量的CCT值均呈显著正相关(r=0.988、0.980、0.988、0.981、0.982、0.973,均P<0.01)。Bland-Altman一致性分析结果显示,角膜内皮镜SP-1P与RTVue XR-OCT、IOLMaster 700与Pentacam HR测量CCT值的95%一致性界限(95%LoA)分别为-16.46~6.14、-10.56~14.48μm,分别有3个(6%)、2个(4%)点落在95%LoA外,测量CCT差异均值线与0距离较小,一致性较好,差异均无统计学意义,在临床上可以接受。结论角膜内皮镜SP-1P与RTVue XR-OCT、IOLMaster 700与Pentacam HR测量低中度近视患者CCT的值较接近,一致性好,可相互替代。

ObjectiveTo compare the correlation and consistency of central corneal thickness(CCT)measured by four different instruments,specular microscope SP-1P,IOLMaster 700,Pentacam HR and RTVue XR-OCT.MethodsA diagnostic test study was performed.A total of 50 right eyes of 50 consecutive outpatients who planned to undergo corneal refractive surgery at Hanyang Aier Eye Hospital from January to May 2022 were included.CCT was measured with the specular microscope SP-1P,IOLMaster 700,Pentacam HR and RTVue XR-OCT,respectively.The differences of CCT measurements by the four instruments were compared.The correlation and consistency between the CCT values was analyzed by Pearson linear analysis and Bland-Altman test,respectively.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Hanyang Aier Eye Hospital(No.HYEYE20221229JM).Written informed consent was obtained from each subject.ResultsThe mean CCT values measured by SP-1P,IOLMaster 700,Pentacam HR and RTVue XR-OCT were(522.68±30.08),(544.06±32.85),(541.00±31.75)and(528.86±31.60)μm,respectively,with a statistically significant overall difference(F=5.09,P=0.002).CCT measurements obtained with SP-1P were lower than those obtained with IOLMaster 700 and Pentacam HR,while the IOLMaster 700 measurements were higher than those of RTVue XR-OCT,showing statistically significant differences(all at P<0.05).Pearson correlation analysis revealed significant positive correlations of CCT measurements between SP-1P and IOLMaster 700,SP-1P and Pentacam HR,SP-1P and RTVue XR-OCT,IOLMaster 700 and Pentacam HR,IOLMaster 700 and RTVue XR-OCT,Pentacam HR and RTVue XR-OCT(r=0.988,0.980,0.988,0.981,0.982,0.973;all at P<0.01).Bland-Altman consistency analysis showed that the 95%limits of agreement(95%LoA)for CCT measurements between SP-1P and RTVue XR-OCT,IOLMaster 700 and Pentacam HR were-16.46-6.14 and-10.56-14.48μm,respectively,with 3(6%)and 2(4%)data points outside the 95%LoA,respectively.The mean difference lines for the CCT measurements were close to 0,indicating good consistency and clinically acceptable differences without statistical significance.ConclusionsCCT values measured with specular microscope SP-1P and RTVue XR-OCT,as well as those measured with IOLMaster and Pentacam HR,are relatively close in patients with low to moderate myopia,show good consistency and can therefore be considered interchangeable.