目的：评价扫频光相干断层扫描生物测量仪IOL Master 700测量健康眼球生物参数的重复性及再现性。

方法：采用诊断试验研究方法。纳入健康受试者103人，均对右眼进行测量。由两位操作熟练的检查者分别应用IOL Master 700测量眼轴长度(AL)、前房深度(ACD)、房水深度(AQD)、角膜曲率(K_m、K₁、K₂)、中央角膜厚度(CCT)、晶状体厚度(LT)、白到白的角膜直径(WTW)、瞳孔直径(PD)，评估IOL Master 700测量眼球生物参数的重复性及再现性。

结果：评价重复性时，A(B)检查者获得的AL、K_m、K₁、K₂、ACD、AQD、LT、CCT、WTW、PD的重测试重复性(TRT)分别为0.018(0.017)mm、0.215(0.270)D、0.325(0.334)D、0.303(0.366)D、0.049(0.041)mm、0.048(0.042)mm、0.058(0.047)mm、6.168(5.779)μm、0.395(0.406)mm、1.097(1.099)mm； 除PD以外，相对变异系数(CoV)均≤1.219%； 组内相关系数(ICC)均≥0.815。评价再现性时，两位检查者获得的AL、K_m、K₁、K₂、ACD、AQD、LT、CCT、WTW、PD的TRT分别为0.018mm、0.240D、0.329D、0.337D、0.048mm、0.048mm、0.055mm、6.396μm、0.420mm、1.144mm； ICC均≥0.900； 除PD的CoV为8.750%外，其余参数CoV均≤1.263%。此外，测量AL时重复性及再现性的ICC均为1.000。

结论：IOL Master 700对除瞳孔直径以外的健康眼生物参数测量具有较好的重复性及再现性，尤其是对于眼轴长度的测量。

METHODS: A diagnostic test study of 103 healthy subjects was implemented. The right eyes were selected for measurements. Ocular biological parameters including axial length(AL), anterior chamber depth(ACD), anterior aqueous depth(AQD), keratometry readings(K), central corneal thickness(CCT), lens thickness(LT), white-to-white corneal diameter(WTW)and pupil diameter(PD)were measured using IOL Master 700 by two experienced examiners. One-way ANOVA was used to evaluate the repeatability and reproducibility for the measurements by IOL Master 700.

RESULTS: Regarding repeatability, the test-retest repeatability(TRT)for AL, mean K(K_m), K₁, K₂, ACD, AQD, LT, CCT, WTW and PD obtained by the two examiners were 0.018(0.017)mm, 0.215(0.270)D, 0.325(0.334)D, 0.303(0.366)D, 0.049(0.041)mm, 0.048(0.042)mm, 0.058(0.047)mm, 6.168(5.779)μm, 0.395(0.406)mm, and 1.097(1.099)mm, respectively; the relative coefficient of variation(CoV)for all measured parameters but the PD were ≤1.219%; the intraclass correlation coefficient(ICC)for all measured parameters were ≥0.815. Regarding reproducibility, the TRT for AL, K_m, K₁, K₂, ACD, AQD, LT, CCT, WTW, and PD obtained were 0.018 mm, 0.240 D, 0.329 D, 0.337 D, 0.048 mm, 0.048mm, 0.055mm, 6.396μm, 0.420mm, and 1.144mm, respectively; the ICC for all measured parameters was ≥0.900; the CoV for all measured parameters were ≤1.263% CoV, except for the PD(8.750%). In addition, the ICC of AL measurement for both repeatability and reproducibility were 1.000.

CONCLUSION: With the exception of pupil diameter, IOL Master 700 demonstrates excellent repeatability and reproducibility in ocular biological measurements for healthy eyes, especially in measurement of axial length.