Baker Rebecca A, Leo Shaun M, Clowes William I N, Chow Isabelle, Jiang Xiaofan, Georgiou Anne L, Calcagni Antonio, Hammond Christopher J, Neveu Magella M, Mahroo Omar A, Robson Anthony G
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road, London, EC1V 2PD, UK.
UCL Institute of Ophthalmology, London, UK.
Doc Ophthalmol. 2025 Apr;150(2):47-64. doi: 10.1007/s10633-025-10009-2. Epub 2025 Apr 1.
To establish age-adjusted reference intervals for the ISCEV standard full-field electroretinogram (ERG) recorded with silver thread electrodes in the lower fornix, based on a combined reference sample involving recordings from reference subjects and transference of data between two centres and two types of electrode.
Silver thread lower fornix ERG reference data from two centres underwent verification for inclusion in the reference sample (n = 251). Comparison analysis was performed to determine whether gold foil reference data could be included in the silver thread reference range, directly or with adjustment. Reference subjects and patients underwent ERG testing with both silver thread and gold foil electrodes (n = 53) and skin electrodes (n = 41). A linear model, fitted to the electrode comparison data, was used to transform gold foil ERG reference data for inclusion in the reference sample (n = 156). The combined sample of 407 reference individuals was used to derive age-adjusted reference limits for the main DA 0.01, DA 3, DA 10, LA 30 Hz and LA 3 ERG components.
Silver thread ERG reference data was sufficiently similar across two centres to justify combination into a single reference sample. Peak times for gold foil and silver thread ERGs were closely comparable (r 0.75-0.98, Bland-Altman bias ≤ 1.6 ms for all ERG components), with LA 30 Hz peak time showing the highest agreement (bias: - 0.2 ms, 95% limits of agreement (LOA): - 1.1 to 0.7 ms, 'silver thread-gold foil'). There was a clinically significant amplitude difference between electrode types: silver thread ERGs were 55-65% of the amplitude of gold foil ERGs (LOA ranged from 29 to 90%) and skin ERGs were 35-38% of the amplitude of silver thread ERGs (LOA ranged from 18 to 54%). Pooled reference data formed a sufficient sample covering 8 decades, from which age-adjusted parametric and nonparametric reference limits were calculated with reference to current guidelines.
ISCEV standard silver thread ERG data were consistent across the two centres, allowing transference of reference data. Reference data recorded with gold foil electrodes can be transformed for inclusion in a silver thread ERG reference range. The study highlights methods of pooling multiple sources of reference data into a larger, more robust sample, pertinent to standardization, clinical management, and multi-centre studies. These reference data could be adopted by other centres or combined with other datasets, following suitable verification.
基于一个综合参考样本，该样本包含参考对象的记录以及两个中心和两种电极类型之间的数据转移，建立使用银线电极在下穹窿记录的国际临床视觉电生理学会（ISCEV）标准全视野视网膜电图（ERG）的年龄校正参考区间。
对来自两个中心的银线在下穹窿的ERG参考数据进行验证，以纳入参考样本（n = 251）。进行比较分析，以确定金箔参考数据是否可以直接或经过调整后纳入银线参考范围。参考对象和患者使用银线和金箔电极（n = 53）以及皮肤电极（n = 41）进行ERG测试。使用拟合到电极比较数据的线性模型来转换金箔ERG参考数据，以纳入参考样本（n = 156）。407名参考个体的综合样本用于得出主要DA 0.01、DA 3、DA 10、LA 30Hz和LA 3 ERG成分的年龄校正参考限值。
两个中心的银线ERG参考数据足够相似，有理由合并为一个单一的参考样本。金箔和银线ERG的峰值时间密切可比（所有ERG成分的r为0.75 - 0.98，布兰德 - 奥特曼偏差≤1.6毫秒），其中LA 30Hz峰值时间的一致性最高（偏差：-0.2毫秒，95%一致性界限（LOA）：-1.1至0.7毫秒，“银线 - 金箔”）。电极类型之间存在临床上显著的幅度差异：银线ERG的幅度是金箔ERG幅度的55 - 65%（LOA范围为29至90%），皮肤ERG的幅度是银线ERG幅度的35 - 38%（LOA范围为18至54%）。汇总的参考数据形成了一个足够大的样本，涵盖8个十年，据此根据当前指南计算了年龄校正的参数和非参数参考限值。
ISCEV标准银线ERG数据在两个中心之间是一致的，允许参考数据的转移。用金箔电极记录的参考数据可以进行转换，以纳入银线ERG参考范围。该研究强调了将多个参考数据源合并为一个更大、更稳健样本的方法，这与标准化、临床管理和多中心研究相关。在经过适当验证后，这些参考数据可供其他中心采用或与其他数据集合并。
