NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.
Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, UK.
BMJ Open. 2024 May 31;14(5):e070857. doi: 10.1136/bmjopen-2022-070857.
INTRODUCTION: The diagnosis of neovascular age-related macular degeneration (nAMD), the leading cause of visual impairment in the developed world, relies on the interpretation of various imaging tests of the retina. These include invasive angiographic methods, such as Fundus Fluorescein Angiography (FFA) and, on occasion, Indocyanine-Green Angiography (ICGA). Newer, non-invasive imaging modalities, predominately Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA), have drastically transformed the diagnostic approach to nAMD. The aim of this study is to undertake a comprehensive diagnostic accuracy assessment of the various imaging modalities used in clinical practice for the diagnosis of nAMD (OCT, OCTA, FFA and, when a variant of nAMD called Polypoidal Choroidal Vasculopathy is suspected, ICGA) both alone and in various combinations. METHODS AND ANALYSIS: This is a non-inferiority, prospective, randomised diagnostic accuracy study of 1067 participants. Participants are patients with clinical features consistent with nAMD who present to a National Health Service secondary care ophthalmology unit in the UK. Patients will undergo OCT as per standard practice and those with suspicious features of nAMD on OCT will be approached for participation in the study. Patients who agree to take part will also undergo both OCTA and FFA (and ICGA if indicated). Interpretation of the imaging tests will be undertaken by clinicians at recruitment sites. A randomised design was selected to avoid bias from consecutive review of all imaging tests by the same clinician. The primary outcome of the study will be the difference in sensitivity and specificity between OCT+OCTA and OCT+FFA (±ICGA) for nAMD detection as interpreted by clinicians at recruitment sites. ETHICS AND DISSEMINATION: The study has been approved by the South Central-Oxford B Research Ethics Committee with reference number 21/SC/0412.Dissemination of study results will involve peer-review publications, presentations at major national and international scientific conferences. TRIAL REGISTRATION NUMBER: ISRCTN18313457.
简介:新生血管性年龄相关性黄斑变性(nAMD)是发达国家导致视力损害的主要原因,其诊断依赖于对视网膜各种影像学检查的解读。这些检查包括有创的血管造影方法,如眼底荧光血管造影(FFA),偶尔也包括吲哚青绿血管造影(ICGA)。较新的非侵入性成像方式,主要是光学相干断层扫描(OCT)和光学相干断层扫描血管造影(OCTA),极大地改变了 nAMD 的诊断方法。本研究旨在对临床实践中用于诊断 nAMD 的各种影像学方法(OCT、OCTA、FFA 和当怀疑存在一种名为息肉样脉络膜血管病变的 nAMD 变体时使用的 ICGA)进行全面的诊断准确性评估,评估单独使用和联合使用这些方法的效果。
方法和分析:这是一项非劣效性、前瞻性、随机诊断准确性研究,共纳入 1067 名参与者。参与者为具有 nAMD 临床特征的患者,他们在英国国家卫生服务二级保健眼科单位就诊。患者将按照标准实践进行 OCT 检查,对于 OCT 上有可疑 nAMD 特征的患者,将邀请他们参与研究。同意参与的患者还将接受 OCTA 和 FFA(如有必要还将接受 ICGA)检查。影像检查的解读将由招募点的临床医生进行。选择随机设计是为了避免由于同一位临床医生连续检查所有影像检查而导致的偏倚。本研究的主要结局是招募点的临床医生解读时,OCT+OCTA 与 OCT+FFA(±ICGA)在 nAMD 检测方面的敏感性和特异性差异。
伦理和传播:该研究已获得南中英格兰-牛津 B 研究伦理委员会的批准,注册号为 21/SC/0412。研究结果的传播将包括同行评议出版物和在主要的国内和国际科学会议上的演讲。
试验注册号:ISRCTN8313457。
J Fr Ophtalmol. 2018-11
Ophthalmol Retina. 2017
Ophthalmology. 2017-12