Rozema Jos J, Wouters Kristien, Mathysen Danny G P, Tassignon Marie-José
Department of Ophthalmology, Antwerp University Hospital, Edegem, Belgium; Department of Medicine and Health Science, University of Antwerp, Wilrijk, Belgium.
Department of Scientific Coordination and Biostatistics, Antwerp University Hospital, Edegem, Belgium; Department of Medicine and Health Science, University of Antwerp, Wilrijk, Belgium.
Am J Ophthalmol. 2014 Dec;158(6):1111-1120.e1. doi: 10.1016/j.ajo.2014.08.014. Epub 2014 Aug 13.
To present an overview of the measurement errors for various biometric devices, as well as a meta-analysis of the agreement between biometric devices using the Pentacam, Orbscan, and IOL Master as a reference.
Meta-analysis of the literature.
The meta-analysis is based on data from 216 articles that compare a total of 24 different devices with the reference devices for the following 9 parameters: mean, steep and flat curvature of the anterior and posterior cornea; central corneal thickness; anterior chamber depth; and axial length. After the weighted average difference between devices has been determined, the "two one-sided t test" was used to test for equivalence between devices within certain thresholds defined by the measurement errors and the influence of these differences on the calculated refraction.
In only 17 of the 70 comparisons a device was equivalent with the reference device within the thresholds set by the measurement error. More lenient thresholds, based on a change in calculated refraction of ±0.25 diopter, increased this number to a maximum of 25/50 comparisons (excluding pachymetry). High degrees of inconsistency were seen in the reported results, which could partially explain the low agreement between devices.
As a rule, biometry measurements taken by different devices should not be considered equivalent, although several exceptions could be identified. We therefore recommend that clinical studies involving multiple device types treat this as a within-subject variable to avoid bias. The follow-up of individual patients using different devices should be avoided at all times.
概述各种生物测量设备的测量误差,并对以Pentacam、Orbscan和IOL Master作为参考的生物测量设备之间的一致性进行荟萃分析。
文献荟萃分析。
荟萃分析基于216篇文章的数据,这些文章比较了总共24种不同设备与参考设备在以下9个参数方面的差异:前、后角膜的平均曲率、陡峭曲率和平坦曲率;中央角膜厚度;前房深度;以及眼轴长度。在确定了设备之间的加权平均差异后,使用“双侧单侧t检验”来检验设备在由测量误差定义的特定阈值内的等效性,以及这些差异对计算出的屈光度的影响。
在70次比较中,只有17次比较中的设备在测量误差设定的阈值内与参考设备等效。基于计算屈光度±0.25屈光度变化的更宽松阈值将这一数字增加到最多25/50次比较(不包括角膜厚度测量)。报告结果中存在高度不一致性,这可以部分解释设备之间一致性较低的原因。
通常,不同设备进行的生物测量不应被视为等效,尽管可以识别出一些例外情况。因此,我们建议涉及多种设备类型的临床研究将此视为受试者内变量以避免偏差。应始终避免对个体患者使用不同设备进行随访。