| Part Ⅰ Repeatability and Reproducibility Evaluation of IOLMaster 700 Measuring Ocular Biological Parameters in Healthy HumanObjective:To evaluate the repeatability and reproducibility of a new biometric instrument IOLMaster 700 based on swept-source optical coherence tomography(SS-OCT)technology to measure ocular biological parameters of healthy human,provide references for clinical applications.Methods:This was a cross-sectional study method.A total of 103 healthy subjects were enrolled,all of who were measured on the right eye.Two skilled examiners measured the axial length(AL),anterior chamber depth(ACD),anterior aqueous depth(AQD),keratometry(K),central corneal thickness(CCT),and lens thickness(LT),white to white corneal diameter(WTW),pupil diameter(PD)parameters using IOLMaster 700.One-way ANOVA was used to analysis data;and within-standard deviation(Sw),test-retest repeatability(TRT),coefficient of variation(CoV)and intraclass correlation coefficient(CC)were used to evaluate the repeatability and reproducibility.Result:The TRT of AL,Km,K1,K2,ACD,AQD,LT,CCT,WTW and PD measured three times by two examiner were 0.018mm and 0.017mm,0.215D and 0.270D,0.325D and 0.334D,0.303D and 0.366D,0.049mm and 0.041mm,0.048mm and 0.042mm,0.058mm and 0.047mm,6.168μm and 5.779μm,0.395mm and 0.406mm,1.097mm and 1.099mm.Except for PD,the remaining parameters CoV≤1.219%;except for WTW and PD,the remaining parameters ICC≥0.989,and the maximum ICC of AL is 1.000.The TRT of AL,Km,K1,K2,ACD,AQD,LT,CCT,WTW and PD measured by different examiners at the same time period were 0.018mm,0.240D,0.329D,0.337D,0.048mm,0.048mm,0.055mm,6.396μm,0.420mm and 1.144mm.CoV except PD was 8.750%,and the remaining parameters Co V≤1.263%.The ICC of all parameters was more than0.900,except the ICC of AL 1.000 at the maximum.Conclusion:IOLMaster 700 has higher accuracy in measuring AL,Km,K1,K2,ACD,AQD,LT,CCT and WTW ocular biological parameters,and the accuracy of AL measurement is the best.The accuracy of PD measurement is the worst.Part Ⅱ Agreement of IOLMaster 700 and OA-2000 in Measuring Ocular Biological Parameters and Calculating IOL Power in Healthy peopleObjective:To evaluate the agreement of IOLMaster 700 and OA-2000 based on SS-OCT technology in measuring ocular biological parameters and calculating IOL power in healthy people.Methods:A cross-sectional study method was used.A total of 103 healthy subjects were included.One examiner applied IOLMaster 700 and OA-2000 to measure the AL,ACD,K,CCT,LT,WTW and PD parameters;five formulas of Haigis,SRK/T,Hoffer Q,Holladay2,and Barrett Universal Ⅱwere employed to calculate the IOL degree.The paired t test was used for data analysis,and 95%agreement of limit(95%LoA)and Bland-Altman scatter plot were used to evaluate the agreement of the two devices in measuring each parameter and calculating the IOL degree.Results:The average differences of the AL,Km,K2,and ACD parameters measured by the two devices were-0.002±0.015 mm,-0.001±0.091D,-0.011±0.157D,and-0.004±0.036mm,the difference was not statistically significant(P>0.05);and the average differences of K1,LT,CCT,WTW and PD were 0.041±0.108D,-0.075±0.042mm,and 17.078±3.872μm,0.143±0.341mm,-1.458±0.794mm,respectively;the difference was statistically significant(P<0.001).The differences between the IOL degrees calculated by the Haigis and Barrett Universal Ⅱ formulas of the two devices are-0.01±0.32D and 0.05±0.33D,respectively;and the difference is not statistically significant(P>0.05);while the SRK/T,Hoffer Q and Holaday2 formulas calculated the differences in IOL degrees as 0.21±0.49D,0.53±0.26D,and 0.26±0.30D,and the differences were statistically significant(P<0.001).Conclusion:IOLMaster 700 and OA-2000 have good agreement in measuring ocular biological parameters AL,Km,K1,K2,ACD and LT in healthy people,and AL has the best agreement.CCT,WTW and PD have poor agreement,and PD has the worst agreement.The Haigis and Barrett Universal Ⅱ formulas of the two devices have good agreement in calculating the IOL degree,but the SRK/T,Hoffer Q and Holaday2 formulas have relatively large differences in the calculation of the IOL degree.In clinical applications,the patient’s ocular condition should be fully evaluated,and the IOL should be selected reasonably.Part III Comparison of Detection Rates between IOLMaster 700 and IOLMaster 500 and Evaluation of Repeatability of IOLMaster700 in Measuring Ocular Biological Parameters of CataractObjective:To evaluate the repeatability of IOLMaster 700 measurement of ocular biological parameters of cataract,and its agreement and detection rate with AL measured by IOLMaster 500.Methods:A total of 225 eyes of 133 patients with cataract were studied by cross-sectional study.The same experienced examiner used IOLMaster 700 and IOLMaster 500 to measure the ocular biological parameters of cataract patients,and recorded the AL,K and ACD.One-way ANOVAand paired ttestwas used toanalysis data;Sw,TRT,CoVandICC indicators were used to evaluate the repeatability of biological parameter measurements,and Bland-Altman scatter plotand 95%LoA to evaluate AL agreement;the detection rate of measurement data was tested for differences using chi-square test.Results:The IOLMaster 700 measured Sw of AL,Km,K1,K2,and ACD were 0.027mm,0.112D,0.148D,0.162D and 0.015mm,CoV was 0.115%～0.510%,ICC≥0.995,and the ICC of AL was 1.000.The AL measured by IOLMaster 700 and IOLMaster 500 were 23.805±2.162mm and 23.782±2.162mm,and the difference was 0.023±0.010mm.The difference was statistically significant(t=33.645,P<0.001),95%LoA is 0.023(0.003～0.043)mm.The AL detection rate of IOLMaster 700 was 93.80%(211/225)and IOLMaster 500 was 87.6%(197/225).The difference was statistically significant(χ2=5.147,P=0.023,P<0.05).Conclusion:IOLMaster 700 measures the ocular biological parameters AL,Km,K1,K2,ACD of cataract patients with high repeatability,and AL repeatability is the best.It has good agreement with IOLMaster 500 measurement of AL parameters,however,the IOLMaster 700 has a higher detection rate for AL with severe opacity and subcapsular cataract. |
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