Gallo Afflitto Gabriele, Chou Tsung-Han, Swaminathan Swarup S, Aiello Francesco, Gedde Steven J, Nucci Carlo, Porciatti Vittorio
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Ophthalmology Unit, Department of Experimental Medicine, University of Rome "Tor Vergata", Rome, Italy.
Ophthalmol Sci. 2023 Apr 29;3(4):100322. doi: 10.1016/j.xops.2023.100322. eCollection 2023 Dec.
To provide standardized confidence limits of the transient pattern electroretinogram (tPERG) P50 and N95 and steady state pattern electroretinogram (ssPERG) amplitudes in normal controls as compared to ocular hypertension (OHT), glaucoma suspect (GS), or early manifest glaucoma (EMG) eyes.
The identification of standardized confidence limits in the context of pattern electroretinogram (PERG) might overcome the high intrinsic variability of the measure, and it might lead to a more intuitive understanding of the results as well as to an easier comparison of data from multiple tests, sites, and operators.
The study protocol was prospectively registered on the International Prospective Register of Systematic Reviews (ID: CRD42022370032). A literature search was conducted on PubMed, Web of Science, and Scopus. Studies comparing PERG raw data in normal control eyes as compared to OHT, GS, or EMG were included. The risk of bias was assessed using the National Institute for Health and Clinical Excellence quality assessment tool. The main outcome was the P50, N95, and ssPERG amplitude difference between the control and the study groups' eyes. The standardized mean difference was calculated as a measure of the effect size for the primary outcome. A subanalysis was conducted based on the type of electrodes adopted for the PERG measurements (invasive vs. noninvasive).
Of the 4580 eligible papers, only 23 were included (1754 eyes). Statistically significant amplitude differences were found in the P50, N95, and ssPERG amplitudes between normal controls and OHT, GS, and EMG eyes. The highest standardized mean difference values were observed in the ssPERG amplitude in all 3 sets of comparison. The subanalysis did not reveal any statistically significant differences between invasive and noninvasive recording strategies.
The use of standardized values as the main outcome measures in the context of the PERG data analysis is a valid approach, normalizing several confounding factors which have affected the clinical utility of PERG both for individual patients and in clinical trials. Steady state PERG apparently better discriminates diseased eyes compared to tPERG. The adoption of skin-active electrodes is able to adequately discriminate between healthy and diseased statuses.
Proprietary or commercial disclosure may be found after the references.
提供正常对照者与高眼压(OHT)、青光眼可疑患者(GS)或早期显性青光眼(EMG)患者眼部相比,瞬态图形视网膜电图(tPERG)P50和N95以及稳态图形视网膜电图(ssPERG)振幅的标准化置信区间。
在图形视网膜电图(PERG)背景下确定标准化置信区间可能会克服该测量方法固有的高变异性,并可能使对结果的理解更直观,也便于比较来自多个测试、地点和操作人员的数据。
研究方案已在国际前瞻性系统评价注册库(注册号:CRD42022370032)上进行前瞻性注册。在PubMed、科学网和Scopus上进行了文献检索。纳入了比较正常对照眼与OHT、GS或EMG患者眼部PERG原始数据的研究。使用英国国家卫生与临床优化研究所质量评估工具评估偏倚风险。主要结局是对照组和研究组眼部之间的P50、N95和ssPERG振幅差异。计算标准化平均差异作为主要结局效应大小的衡量指标。根据PERG测量所采用电极的类型(侵入性与非侵入性)进行亚组分析。
在4580篇符合条件的论文中,仅纳入23篇(1754只眼)。在正常对照与OHT、GS和EMG患者眼部之间,P50、N95和ssPERG振幅存在统计学显著差异。在所有3组比较中,ssPERG振幅的标准化平均差异值最高。亚组分析未发现侵入性和非侵入性记录策略之间存在任何统计学显著差异。
在PERG数据分析中使用标准化值作为主要结局指标是一种有效的方法,可将影响PERG在个体患者和临床试验中临床应用的多个混杂因素进行标准化。与tPERG相比,稳态PERG显然能更好地区分患病眼部。采用皮肤活性电极能够充分区分健康和患病状态。
专有或商业披露信息可在参考文献之后找到。