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确定与视力和屈光不正测量相关的变异性:一项系统评价。

Determining the Variability Associated with Visual Acuity and Refractive Error Measurements: A Systematic Review.

作者信息

van der Zee Casper, Muijzer Marc B, Claessens Janneau L J, Wisse Robert P L

机构信息

Ophthalmology Department, University Medical Center Utrecht, Utrecht, The Netherlands.

Vision 2020 The Netherlands the Right to Sight non-profit organization, Doorn, The Netherlands; Easee BV, Amsterdam, The Netherlands.

出版信息

Ophthalmology. 2025 Sep;132(9):1020-1032. doi: 10.1016/j.ophtha.2025.04.021. Epub 2025 Apr 26.

Abstract

TOPIC

The goal of this systematic review was to evaluate the measurement variability of distance visual acuity (VA) and refractive error (RE).

CLINICAL RELEVANCE

Accurately measuring VA and RE is fundamental to eye care; however, no scientific consensus has been reached on the measurement variability. Scientific literature suggests limits of variability of ±0.15 logarithm of the minimum angle of resolution (logMAR) for VA and ±0.5 diopters (D) for RE. This lack of consensus on variability affects our clinical decision-making, regulations, and research.

METHODS

This systematic review was performed in accordance with Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines and was registered at PROSPERO (ID CRD42024554663). We searched Medline, PubMed, and Embase databases. The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was then used to assess the risk of bias (RoB). We included studies of adults that directly compared distance VA or RE and reported the limits of agreement (LoA) and mean difference. An overall summarized mean is reported in LoA, and the certainty of evidence was assessed using Grading of Recommendation, Assessment, Development, and Evaluation.

RESULTS

After applying the eligibility criteria, 12 studies reporting on VA and 6 studies reporting on RE were included. Six of the 18 studies (33%) scored a low RoB in at least 3 of 4 QUADAS-2 domains. Only 1 study had a low RoB in all four QUADAS-2 domains, whereas 13 of 18 studies had a high or unclear RoB in at least 3 of 4 QUADAS-2 domains. In 25 of 36 subgroups (69%), the LoA exceeded the suggested clinical accepted variability ranges for VA (±0.15 logMAR) or RE (±0.5 D). The overall summarized mean is ±0.20 logMAR (95% confidence interval [CI], 0.17-0.23) for VA and ±0.70 D (95% CI, 0.50-0.89) for RE. The Grading of Recommendation, Assessment, Development, and Evaluation certainty of evidence was very low.

CONCLUSIONS

This study demonstrates that distance VA and RE measurements have a high measurement variability in adults, exceeding the suggested limits of variability (VA: ±0.15 logMAR, RE: ±0.5 D). The evidence either fails to support the suggested limits of variability or is based on studies with methodological weaknesses, with a very low certainty of evidence. Methodological rigorous studies are therefore needed to accurately estimate the suggested limits of variability. For now, we propose using the overall summarized mean LoA obtained in our study as a provisional frame of reference (i.e., ±0.20 logMAR and ±0.70 D).

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

摘要

主题

本系统评价的目的是评估远距离视力(VA)和屈光不正(RE)测量的变异性。

临床相关性

准确测量VA和RE是眼科护理的基础;然而,关于测量变异性尚未达成科学共识。科学文献表明,VA的变异性限度为最小分辨角对数(logMAR)的±0.15,RE的变异性限度为±0.5屈光度(D)。这种在变异性方面缺乏共识影响了我们的临床决策、法规制定和研究。

方法

本系统评价按照系统评价和Meta分析的首选报告项目指南进行,并在国际前瞻性系统评价注册库(PROSPERO)注册(ID CRD42024554663)。我们检索了Medline、PubMed和Embase数据库。然后使用诊断准确性研究质量评估2(QUADAS - 2)工具评估偏倚风险(RoB)。我们纳入了直接比较远距离VA或RE并报告一致性界限(LoA)和平均差异的成人研究。在LoA中报告了总体汇总均值,并使用推荐分级、评估、制定和评价方法评估证据的确定性。

结果

应用纳入标准后,纳入了12项报告VA的研究和6项报告RE的研究。18项研究中的6项(占33%)在QUADAS - 2的4个领域中的至少3个领域得分低RoB。只有1项研究在QUADAS - 2的所有4个领域得分低RoB,而18项研究中的13项在QUADAS - 2的4个领域中的至少3个领域得分高RoB或不明确RoB。在36个亚组中的25个(占69%)中,LoA超过了VA(±0.15 logMAR)或RE(±0.5 D)建议的临床可接受变异性范围。VA的总体汇总均值为±0.20 logMAR(95%置信区间[CI],0.17 - 0.23),RE的总体汇总均值为±0.70 D(95% CI,0.50 - 0.89)。推荐分级、评估、制定和评价方法的证据确定性非常低。

结论

本研究表明,成人远距离VA和RE测量具有较高的测量变异性,超过了建议的变异性限度(VA:±0.15 logMAR,RE:±0.5 D)。证据要么不支持建议的变异性限度,要么基于方法存在缺陷的研究,证据确定性非常低。因此,需要进行方法严谨的研究来准确估计建议的变异性限度。目前,我们建议将本研究中获得的总体汇总均值LoA用作临时参考框架(即±0.20 logMAR和±0.70 D)。

财务披露

专有或商业披露信息可在参考文献之后找到。

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