Hoopes Vision Research Center, Hoopes Vision, Draper, Utah, United States.
John A. Moran Eye Center, Department of Ophthalmology and Visual Sciences, University of Utah School of Medicine, Salt Lake City, Utah, United States.
Expert Rev Med Devices. 2022 Apr;19(4):375-383. doi: 10.1080/17434440.2022.2075725. Epub 2022 May 19.
To assess the repeatability and reproducibility of corneal measurements performed by the Galilei G6 and determine its agreement with the Pentacam® AXL.
105 eyes underwent examination by both devices, measuring nine parameters. Paired t-tests, Deming Regression, and Bland-Altman plots were used to determine agreement. Analysis of Variance was used to determine repeatability and reproducibility.
Measurements showed no clinically significant differences between the two devices. On average, the Galilei G6 measured axial length longer than the Pentacam® AXL by 0.05 mm ± 0.03 mm (p < 0.001), just 0.2% of the mean value and therefore clinically insignificant. It measured central corneal thickness and anterior chamber depth 3.77 μm ± 7.71 μm longer (p < 0.001) and 0.04 mm ± 0.07 μm shorter (p < 0.001), respectively. They are also clinically insignificant, constituting just 0.7% and 1% of the mean values. The results showed evidence of repeatability and reproducibility. Only measurements of corneal cylinder showed some clinically significant variance.
The Galilei G6 and Pentacam® AXL measurements show evidence of repeatability, reproducibility, and agreement for examined parameters. Certain caution needs to be applied in cases with moderate or severe corneal cylinder, due to discrepancies in repeatability and reproducibility of corneal cylinder measurements with the Galilei G6.
评估 Galilei G6 进行的角膜测量的可重复性和再现性,并确定其与 Pentacam® AXL 的一致性。
105 只眼接受了两种设备的检查,共测量了 9 个参数。采用配对 t 检验、Deming 回归和 Bland-Altman 图来确定一致性。方差分析用于确定可重复性和再现性。
两种设备的测量值无临床显著差异。平均而言,Galilei G6 测量的眼轴长度比 Pentacam® AXL 长 0.05 毫米±0.03 毫米(p<0.001),仅为平均值的 0.2%,因此无临床意义。它测量的中央角膜厚度和前房深度分别长 3.77 微米±7.71 微米(p<0.001)和短 0.04 毫米±0.07 毫米(p<0.001)。它们也无临床意义,仅占平均值的 0.7%和 1%。结果显示具有可重复性和再现性。只有角膜柱的测量值显示出一些临床显著差异。
Galilei G6 和 Pentacam® AXL 的测量值显示出可重复性、再现性和所检查参数的一致性。在角膜柱中度或重度的情况下,需要谨慎应用,因为 Galilei G6 的角膜柱测量的可重复性和再现性存在差异。