Liu Henry, Ji Xiang, Dhaliwal Sabrina, Rahman Syeda Naima, McFarlane Michelle, Tumber Anupreet, Locke Jeff, Wright Tom, Vincent Ajoy, Westall Carol
Ophthalmology and Vision Sciences, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Doc Ophthalmol. 2018 Dec;137(3):169-181. doi: 10.1007/s10633-018-9660-z. Epub 2018 Oct 24.
The full-field electroretinogram (ff-ERG) is a widely used clinical tool to evaluate generalized retinal function by recording electrical potentials generated by the cells in the retina in response to flash stimuli and requires mydriasis. The purpose of this study was to determine the intra-visit reliability and diagnostic capability of a handheld, mydriasis-free ERG, RETeval (LKC Technologies, Gaithersburg, MD, USA), in comparison with the standard clinical ff-ERG by measuring responses recommended by the International Society for Clinical Electrophysiology of Vision (ISCEV).
This prospective, cross-sectional study included 35 patients recruited at the Hospital for Sick Children (median age = 17, range 11 months-69 years) who had undergone a clinical ff-ERG according to ISCEV standards. For RETeval (n = 35), pupils were undilated in most (n = 29) and sensor strip electrodes were placed under the inferior orbital rim. Stimulus settings on RETeval were equivalent to those used in the clinical ERG. Fifty-seven control participants (median age = 22, range 8-65 years) underwent undilated RETeval ERG to establish standard values for comparison. Patient waveform components with amplitudes < 5th percentile, or implicit times > 95th percentile of normal relative to control data were classified as abnormal for the RETeval system.
The RETeval system demonstrated a high degree of within-visit reliability for amplitudes (ICC = 0.82) and moderate reliability for implicit times (ICC = 0.53). Cohen's Kappa analysis revealed a substantial level of agreement between the diagnostic capability of RETeval in comparison with clinical ff-ERG (k = 0.82), with a sensitivity and specificity of 1.00 and 0.82, respectively. Pearson's correlations for clinical ERG versus RETeval demonstrated a positive correlation for amplitudes across the rod (r = 0.65) and cone (r = 0.74) ERG waveforms. Bland-Altman plots showed no bias between the mean differences across all amplitude and implicit time parameters of the two systems.
The present study demonstrated that RETeval is a reliable tool with reasonable accuracy in comparison with the clinical ERG. The portable nature of RETeval system enables its incorporation at resource-limited centers where the ff-ERG is not readily available. The avoidance of sedation and pupillary dilation are added advantages of RETeval ERG.
全视野视网膜电图（ff-ERG）是一种广泛应用的临床工具，通过记录视网膜细胞对闪光刺激产生的电位来评估整体视网膜功能，并且需要散瞳。本研究的目的是通过测量国际临床视觉电生理学会（ISCEV）推荐的反应，来确定一种手持式、无需散瞳的视网膜电图设备RETeval（LKC Technologies，美国马里兰州盖瑟斯堡）与标准临床ff-ERG相比的同次就诊可靠性和诊断能力。
这项前瞻性横断面研究纳入了35名在病童医院招募的患者（年龄中位数 = 17岁，范围11个月至69岁），他们根据ISCEV标准接受了临床ff-ERG检查。对于RETeval（n = 35），大多数患者（n = 29）未散瞳，传感带电极置于眶下缘下方。RETeval的刺激设置与临床ERG中使用的设置相同。57名对照参与者（年龄中位数 = 22岁，范围8至65岁）接受了未散瞳的RETeval ERG检查以建立用于比较的标准值。对于RETeval系统，振幅低于第5百分位数或相对于对照数据的隐含时间高于第95百分位数的患者波形成分被分类为异常。
RETeval系统在振幅方面显示出高度的同次就诊可靠性（组内相关系数ICC = 0.82），在隐含时间方面显示出中等可靠性（ICC = 0.53）。Cohen's Kappa分析显示，与临床ff-ERG相比，RETeval的诊断能力之间存在高度一致性（k = 0.82），敏感性和特异性分别为1.00和0.82。临床ERG与RETeval的Pearson相关性显示，在整个视杆（r = 0.65）和视锥（r = 0.74）ERG波形的振幅方面呈正相关。Bland-Altman图显示，两个系统在所有振幅和隐含时间参数的平均差异之间无偏差。
本研究表明，与临床ERG相比，RETeval是一种具有合理准确性的可靠工具。RETeval系统的便携性使其能够在资源有限且不易获得ff-ERG的中心使用。避免镇静和瞳孔散大是RETeval ERG的额外优势。
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