Purpose

To evaluate the accuracy and the inter and intra-observer reliability of the centration assessment of extended depth of focus (EDOF) contact lenses (CL) using corneal topography.

Method

EDOF soft CLs (Mylo, Mark’Ennovy) were fitted on thirty-three myopic students (25 females), aged 19–28 years (22.7 ± 2.0 years). For any EDOF CL, a topography over the CL and a slit lamp (SL) digital picture were taken in random order. For the topographic images, the position of the EDOF CL centre, with respect to the pupil centre, was detected by two different practitioners (one newly graduated and one with more than 20 years of clinical experience respectively) and repeated after 15 days. This measurement was compared to the one taken through the SL, considered as the gold standard, and assessed using the instrument software.

Results

EDOF CLs resulted decentred inferiorly and temporally ranging, in the case of slit lamp assessment, between −0.27 ± 0.19 and 0.22 ± 0.23 mm horizontally and between −0.12 ± 0.31 and −0.17 ± 0.34 mm vertically, for the right and left eye respectively. The accuracy of the topographic assessment in determining EDOF CL centration was found to be very good compared to the SL assessment. No differences were found for the left eye, whereas in the right eye, a less temporally decentred position of the CL was detected by the topographical method (p < 0.05). However, this difference appeared clinically negligible (0.14 ± 0.22 mm). Inter-observer reliability (the differences between the two practitioners in assessing the EDOF centre) resulted significant only for the vertical coordinates of the centre position (p < 0.05). Concerning intra-observer reliability, better coefficient of precision and reliability between measurements within the same session were achieved by the more experienced practitioner, as well as a better level of the intraclass correlation coefficient in test–retest.

Conclusion

The centration of the EDOF CL investigated in this study can be accurately detected by a corneal topography performed over CLs. Inter-observer reliability resulted good whereas the intra-observer reliability resulted partially affected by the level of clinical experience of the practitioner.

中文翻译：

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用于近视进展控制的扩展焦深接触镜的中心评估

目的

评估使用角膜地形图对扩展焦深 (EDOF) 隐形眼镜 (CL) 进行定心评估的准确性以及观察者间和观察者内的可靠性。

方法

EDOF 软 CL（Mylo，Mark'Ennovy）安装在 33 名近视学生（25 名女性）身上，年龄在 19-28 岁（22.7 ± 2.0 岁）之间。对于任何 EDOF CL，以随机顺序拍摄 CL 上的地形图和裂隙灯 (SL) 数字照片。对于地形图像，EDOF CL 中心相对于瞳孔中心的位置由两名不同的从业者（一名刚毕业，一名分别具有 20 多年临床经验）检测，并在 15 天后重复。将该测量值与通过 SL 进行的测量值（被视为黄金标准）进行比较，并使用仪器软件进行评估。

结果

在裂隙灯评估的情况下，EDOF CL 在下方和时间范围内偏心，水平方向在 -0.27 ± 0.19 和 0.22 ± 0.23 毫米之间，垂直方向在 -0.12 ± 0.31 和 -0.17 ± 0.34 毫米之间，分别适用于右眼和左眼。与 SL 评估相比，地形评估在确定 EDOF CL 中心方面的准确性被发现非常好。左眼没有发现差异，而在右眼中，通过地形图方法检测到 CL 的时间偏心位置较小 (p < 0.05)。然而，这种差异在临床上似乎可以忽略不计 (0.14 ± 0.22 mm)。观察者间的可靠性（两位从业者在评估 EDOF 中心时的差异）仅对中心位置的垂直坐标产生显着影响（p < 0.05）。

结论

本研究中调查的 EDOF CL 的中心可以通过在 CL 上执行的角膜地形图准确检测。观察者间的可靠性结果良好，而观察者内部的可靠性部分受到从业者临床经验水平的影响。