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针对来自美国和中国患者的光学低相干干涉测量法和部分相干干涉测量法光学生物测量仪的多中心研究。

Multicenter study of optical low-coherence interferometry and partial-coherence interferometry optical biometers with patients from the United States and China.

作者信息

Hoffer Kenneth J, Shammas H John, Savini Giacomo, Huang Jinhai

机构信息

From Stein Eye Institute (Hoffer), University of California, Los Angeles; St. Mary's Eye Center (Hoffer), Santa Monica, California; Keck School of Medicine (Shammas), Los Angeles, and; Shammas Eye Medical Center (Shammas), Lynwood, California, USA; G.B. Bietti Foundation IRCCS (Savini), Rome, Italy; School of Ophthalmology and Eye Hospital (Huang), Wenzhou Medical University, Wenzhou, China.

From Stein Eye Institute (Hoffer), University of California, Los Angeles; St. Mary's Eye Center (Hoffer), Santa Monica, California; Keck School of Medicine (Shammas), Los Angeles, and; Shammas Eye Medical Center (Shammas), Lynwood, California, USA; G.B. Bietti Foundation IRCCS (Savini), Rome, Italy; School of Ophthalmology and Eye Hospital (Huang), Wenzhou Medical University, Wenzhou, China.

出版信息

J Cataract Refract Surg. 2016 Jan;42(1):62-7. doi: 10.1016/j.jcrs.2015.07.041.

Abstract

PURPOSE

To evaluate the agreement between the measurements provided by a new optical biometer, the Aladdin, based on optical low-coherence interferometry (OLCI), and those provided by the most commonly used optical biometer (IOLMaster 500), based on partial-coherence interferometry (PCI).

SETTING

Multicenter clinical trial.

DESIGN

Prospective evaluation of diagnostic test.

METHODS

In this study, 2 samples of adult patients were enrolled, 1 in the United States and the other in China. The U.S. group included a sample of consecutive patients scheduled for cataract surgery. The China group included a sample of healthy subjects with no cataracts. In both cases, only 1 eye of each patient was analyzed. Axial length (AL), corneal power (in diopters [D]) (K), anterior chamber depth (ACD) (corneal epithelium to lens), and corneal astigmatism were measured. All values were analyzed using a paired t test, the Pearson product-moment correlation coefficient (r), and Bland-Altman plots.

RESULTS

In the U.S. and China groups, the OLCI mean AL values did not show a statistically significant difference from PCI values and showed excellent agreement and correlation. On the contrary, OLCI measured a lower mean K (-0.14 D) and a deeper ACD measurements (U.S. +0.16 mm and China +0.05 mm). These differences were statistically significant (P < .0001). Vector analysis did not show a statistically significant difference in astigmatism measurements.

CONCLUSIONS

Agreement between OLCI and PCI was good. However, the small but statistically significant differences in K and ACD measurements make constant optimization necessary when calculating the intraocular lens power using theoretical formulas.

FINANCIAL DISCLOSURE

Dr. Hoffer licenses the registered trademark name Hoffer to Carl Zeiss-Meditec (PCI), Haag-Streit (Lenstar), Movu (Argos), Oculus (Pentacam, AXL), Nidek (AL-Scan), Tomey (OA-2000), Topcon EU Visia Imaging (Aladdin), Ziemer (Galilei G6), and all A-scan biometer manufacturers. Dr. Shammas licenses his formulas to Carl Zeiss-Meditec (PCI), Haag-Streit (Lenstar), Nidek (AL-Scan), and Topcon EU (Visia Imaging) (Aladdin). None of the other authors has a financial or proprietary interest in any material or method mentioned.

摘要

目的

评估一种基于光学低相干干涉测量法(OLCI)的新型光学生物测量仪阿拉丁与最常用的基于部分相干干涉测量法(PCI)的光学生物测量仪(IOLMaster 500)所提供测量值之间的一致性。

设置

多中心临床试验。

设计

诊断试验的前瞻性评估。

方法

在本研究中,招募了两组成年患者样本,一组在美国,另一组在中国。美国组包括连续安排进行白内障手术的患者样本。中国组包括无白内障的健康受试者样本。在这两种情况下,仅分析每位患者的一只眼睛。测量眼轴长度(AL)、角膜屈光力(以屈光度[D]表示)(K)、前房深度(ACD)(角膜上皮至晶状体)和角膜散光。所有值均使用配对t检验、Pearson积矩相关系数(r)和Bland-Altman图进行分析。

结果

在美国组和中国组中,OLCI测量的平均AL值与PCI测量值相比,差异无统计学意义,且显示出极好的一致性和相关性。相反,OLCI测量的平均K值较低(-0.14 D),ACD测量值较深(美国组+0.16 mm,中国组+0.05 mm)。这些差异具有统计学意义(P <.0001)。矢量分析显示散光测量值差异无统计学意义。

结论

OLCI与PCI之间的一致性良好。然而,K值和ACD测量值虽小但具有统计学意义的差异使得在使用理论公式计算人工晶状体屈光力时需要不断优化。

财务披露

霍弗博士将注册商标名霍弗授权给卡尔蔡司-美迪泰克公司(PCI)、哈格-施特赖特公司(Lenstar)、莫武公司(Argos)、奥culus公司(Pentacam、AXL)、尼德克公司(AL-Scan)、拓普康欧洲公司(Visia Imaging)(阿拉丁)、齐默公司(Galilei G6)以及所有A超生物测量仪制造商。沙马斯博士将他的公式授权给卡尔蔡司-美迪泰克公司(PCI)、哈格-施特赖特公司(Lenstar)、尼德克公司(AL-Scan)和拓普康欧洲公司(Visia Imaging)(阿拉丁)。其他作者均未对文中提及的任何材料或方法拥有财务或专利权益。

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