Raji Shabnam, Thirunavukarasu Arun James, Taylor Laura Jayne, MacLaren Robert Edward
Nuffield Laboratory of Ophthalmology, Department of Clinical Neurosciences, University of Oxford, Oxford, UK
Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
BMJ Open. 2025 May 27;15(5):e097970. doi: 10.1136/bmjopen-2024-097970.
To identify currently available functional vision tests and evaluate their use as clinical trial outcome measures in ophthalmology.
Scoping review using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-analysis Extension for Scoping Reviews) guidelines.
A literature search was conducted in MEDLINE and Embase (via Ovid) for articles published between 1 January 2003 and 1 August 2024. Additional grey literature was sourced from institutional repositories, conference proceedings and a manual citation search. Article screening was conducted against a predefined inclusion criteria by two independent, masked reviewers, with a third reviewer acting as arbiter. The inclusion criteria were English language articles which feature a test assessing functional vision in patients with an ophthalmological disease. Details of source characteristics, test methodology and accessibility and evidence of test validation were collected.
Of 2665 articles returned by the search, 73 were included and 45 unique tests of functional vision were identified. Diseases affecting the peripheral retina were mainly affected, accounting for 77% (56 out of 73) of the diseases featured in all included studies. Overall, 82% (37 out of 45) functional vision tests reported evidence of statistical validation with varying robustness. Functional vision tests were mapped to domains of orientation and mobility, facial recognition, observer-rated task performance, visual search and driving. Obstacle courses assess vision-guided orientation and mobility, correlate highly with clinical measures of visual function in severe peripheral retinal disease and have been validated for use in clinical trials. Their requirement of physical space and time limits utility in multicentre trials; equivalent tests leveraging virtual reality and eye tracking technologies are in development. Early iterations of visual search tests to simulated realistic scenes have demonstrated discriminative ability, even in paediatric patients.
Functional vision tests can facilitate research into future novel ophthalmological treatments that prioritise patients in terms of how clinical benefit is defined. The principal barriers to the uptake of these tests are lack of accessibility, low quality validation and that many tests remain early in their development stage. This review captures the current landscape of functional vision tests and serves as a reference for investigators and regulatory bodies to evaluate the suitability of these tests for ophthalmic clinical trials.
确定当前可用的功能性视力测试，并评估其作为眼科临床试验结果指标的用途。
采用PRISMA-ScR（系统评价和Meta分析扩展的首选报告项目，用于范围综述）指南进行范围综述。
在MEDLINE和Embase（通过Ovid）中检索2003年1月1日至2024年8月1日发表的文章。另外的灰色文献来自机构知识库、会议论文集和手动引文检索。由两名独立的、不知情的评审员根据预先定义的纳入标准进行文章筛选，第三名评审员担任仲裁人。纳入标准为英文文章，其特点是有一项评估眼科疾病患者功能性视力的测试。收集了来源特征、测试方法、可及性以及测试验证证据的详细信息。
在检索返回的2665篇文章中，73篇被纳入，确定了45项独特的功能性视力测试。影响周边视网膜的疾病受影响主要，占所有纳入研究中所涉及疾病的77%（73项中的56项）。总体而言，82%（45项中的37项）功能性视力测试报告了具有不同稳健性的统计验证证据。功能性视力测试被映射到定向与移动、面部识别、观察者评定的任务表现、视觉搜索和驾驶等领域。障碍课程评估视觉引导的定向与移动，与严重周边视网膜疾病的视觉功能临床测量高度相关，并已在临床试验中得到验证。它们对物理空间和时间的要求限制了在多中心试验中的实用性；利用虚拟现实和眼动追踪技术的等效测试正在开发中。早期的视觉搜索测试迭代到模拟现实场景已显示出判别能力，即使在儿科患者中也是如此。
功能性视力测试有助于对未来新型眼科治疗方法的研究，这些治疗方法在如何定义临床益处方面优先考虑患者。采用这些测试的主要障碍是可及性不足、验证质量低以及许多测试仍处于早期开发阶段。本综述描绘了功能性视力测试的当前状况，并为研究人员和监管机构评估这些测试对眼科临床试验的适用性提供参考。
