Comparison of Precision, Agreement, and Accuracy of Two Swept-Source Optical Coherence Tomography Biometers.

IF 3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Diagnostics Pub Date : 2024-10-30 DOI:10.3390/diagnostics14212422
Mercè Guarro, Meritxell Vázquez, Juan Carlos Díaz, Sergi Ruiz, Maties Gimeno, Lara Rodríguez, Elena López, Laura Sararols, Marc Biarnés
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Abstract

Background/Objectives: This study's aim was to compare the precision, agreement, and accuracy in axial length (AL) measurements of Argos® (Alcon Healthcare, US) and Eyestar 900® (Haag-Streit, Switzerland) swept-source optical coherence tomography (SS-OCT) biometers. Methods: We performed a prospective evaluation of two diagnostic devices. Three consecutive measurements of AL with the Argos® and the Eyestar® 900 SS-OCT biometers were conducted in random order in eyes undergoing cataract surgery in Barcelona, Spain. The main endpoint was the median difference in AL between devices. Secondary endpoints included agreement on Bland-Altman plots and 95% limits of agreement (LoAs), repeatability as measured within-subject standard deviation (SW), percent of failed AL measurements, percent of eyes within ±0.50 D and ±1.00 D one month after surgery, and median and mean prediction error. Results: We included 107 eyes of 107 patients (60.8% females, mean age of 73.1 years). The median difference in AL (Argos®-Eyestar 900®) was -0.01 mm (interquartile range [IQR], 0.06), p = 0.01. The 95% LoAs were -0.11 to +0.08 mm, with a trend towards less extreme measurements with Argos® for very short and long eyes. The median (IQR) Sw was 0.0058 (0.0058) and 0.0000 (0.0058) for Argos® and Eyestar 900®, respectively. There were no failed AL measurements with either device (0%, 95% CI = 0% to 3.4%). Overall, 96.1% of eyes were within ±0.50 D and 100% were within ±1.00 D. Conclusions: Argos® and Eyestar 900® provided statistically different but clinically negligible differences in AL. However, they are not interchangeable in very long or short eyes, due to the different principles used to determine AL.

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两种扫源光学相干断层成像生物测量仪的精度、一致性和准确性比较。
背景/目的:本研究旨在比较 Argos® (Alcon Healthcare, US) 和 Eyestar 900® (Haag-Streit, Switzerland) 扫源光学相干断层扫描 (SS-OCT) 生物测量仪的轴向长度 (AL) 测量精度、一致性和准确性。方法:我们对两种诊断设备进行了前瞻性评估。使用 Argos® 和 Eyestar® 900 SS-OCT 生物测量仪,以随机顺序对西班牙巴塞罗那接受白内障手术的眼睛连续进行了三次 AL 测量。主要终点是两种设备的AL差异中位数。次要终点包括Bland-Altman图上的一致性和95%的一致性限值(LoAs)、以受试者内标准偏差(SW)衡量的可重复性、AL测量失败的百分比、术后一个月±0.50 D和±1.00 D以内的眼睛百分比,以及预测误差的中位数和平均值。结果:我们共纳入了 107 名患者的 107 只眼睛(女性占 60.8%,平均年龄 73.1 岁)。AL(Argos®-Eyestar 900®)的中位数差异为-0.01 mm(四分位距[IQR],0.06),P = 0.01。95% LoAs 为 -0.11 至 +0.08 mm,对于极短和极长的眼睛,Argos® 的极端测量值有减少的趋势。Argos® 和 Eyestar 900® 的 Sw 中位数(IQR)分别为 0.0058 (0.0058) 和 0.0000 (0.0058)。两种设备均未出现 AL 测量失败的情况(0%,95% CI = 0% 至 3.4%)。总体而言,96.1% 的眼睛在 ±0.50 D 以内,100% 的眼睛在 ±1.00 D 以内:Argos® 和 Eyestar 900® 在角膜屈光度方面存在统计学差异,但在临床上可以忽略不计。然而,由于用于确定AL的原理不同,它们在超长或超短眼中不能互换。
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来源期刊
Diagnostics
Diagnostics Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry
CiteScore
4.70
自引率
8.30%
发文量
2699
审稿时长
19.64 days
期刊介绍: Diagnostics (ISSN 2075-4418) is an international scholarly open access journal on medical diagnostics. It publishes original research articles, reviews, communications and short notes on the research and development of medical diagnostics. There is no restriction on the length of the papers. Our aim is to encourage scientists to publish their experimental and theoretical research in as much detail as possible. Full experimental and/or methodological details must be provided for research articles.
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