Department of Ophthalmology, Semmelweis University, Budapest, Hungary.
Ophthalmology. 2010 Apr;117(4):738-46. doi: 10.1016/j.ophtha.2009.08.039. Epub 2010 Jan 15.
To evaluate the reproducibility of peripapillary retinal nerve fiber layer thickness (RNFLT) and ganglion cell complex (GCC) measurements made with the RTVue-100 Fourier-domain optical coherence tomography (OCT) device (Optovue, Inc., Fremont, CA) and to determine the influence of 4 factors: pupil dilation, subject age, experience in imaging examinations, and glaucoma severity.
Prospective study for evaluation of a diagnostic test.
Thirty-seven hospital-based participants (14 normal and ocular hypertensive subjects, 11 patients with moderate and 12 with severe glaucoma), all experienced in imaging examinations, and 40 consecutive screening trial participants lacking such experience.
One eye of all participants was imaged 5 times. For the hospital-based participants, on the same day the measurement series was repeated after pupil dilation. For determination of intersession reproducibility, measurements were performed again 3 months later.
Intrasession and intersession coefficient of variation (CV), intraclass correlation coefficient (ICC), intratest variability, and test-retest variability.
For the average and quadrant RNFLT parameters and the GCC parameters, intrasession ICC varied between 93.9% and 99.0%, intrasession CV between 1.95% and 5.69%, and intratest variability varied between 3.11 and 9.13 microm. Most thickness values, all intrasession CV and intratest variability values, and the signal strength index were not changed significantly after pupil dilation. Intrasession CV of the 16 peripapillary RNFLT sectors varied between 4.90% and 11.66%. Most intrasession CV values increased significantly with increased disease severity, but intratest variability for average RNFLT and the quadrant RNFLT parameters, which are used for statistical comparison with the normative database, were unaffected by the severity of glaucoma. Patient age and experience in imaging examinations had no influence on intrasession CV. Intratest variability and intrasession CV represented 79.1% to 98.6% and 77.1% to 95.0% of test-retest variability and intervisit CV, respectively, for the average and quadrant RNFLT and the GCC parameters.
Intrasession and intersession reproducibility of RNFLT and GCC measurements with the RTVue-100 OCT are satisfactory for diagnostic purposes, both in normals and in patients with different glaucoma severity. Pupil dilation, age, and experience in imaging examinations did not influence reproducibility in a clinically significant manner.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
评估使用 RTVue-100 傅里叶域光学相干断层扫描仪（OCT）（Optovue，Inc.，弗里蒙特，加利福尼亚州）进行的视盘周围视网膜神经纤维层厚度（RNFLT）和节细胞复合体（GCC）测量的可重复性，并确定 4 个因素的影响：瞳孔扩张、受试者年龄、成像检查经验和青光眼严重程度。
用于评估诊断测试的前瞻性研究。
37 名医院参与者（14 名正常和高眼压受试者、11 名中度青光眼患者和 12 名重度青光眼患者），均有成像检查经验，以及 40 名连续筛查试验参与者，无此类经验。
对所有参与者的一只眼睛进行 5 次成像。对于医院参与者，在同一天重复测量系列，然后进行瞳孔扩张。为了确定随访内的可重复性，3 个月后再次进行测量。
随访内和随访间变异系数（CV）、组内相关系数（ICC）、试验内变异性和测试-重测变异性。
对于平均和象限 RNFLT 参数和 GCC 参数，随访内 ICC 为 93.9%至 99.0%，随访内 CV 为 1.95%至 5.69%，试验内变异性为 3.11 至 9.13μm。大多数厚度值、所有随访内 CV 和试验内变异性值以及信号强度指数在瞳孔扩张后均无显著变化。16 个视盘周围 RNFLT 区的随访内 CV 为 4.90%至 11.66%。大多数随访内 CV 值随着疾病严重程度的增加而显著增加，但用于与正常数据库进行统计比较的平均 RNFLT 和象限 RNFLT 参数的试验内变异性不受青光眼严重程度的影响。患者年龄和成像检查经验对随访内 CV 没有影响。试验内变异性和随访内 CV 分别代表平均和象限 RNFLT 和 GCC 参数的测试-重测变异性和随访间 CV 的 79.1%至 98.6%和 77.1%至 95.0%。
在正常人和不同严重程度青光眼患者中，RTVue-100 OCT 的 RNFLT 和 GCC 测量的随访内和随访间可重复性均足以满足诊断目的。瞳孔扩张、年龄和成像检查经验并未以临床显著的方式影响可重复性。
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