Study protocol: optical coherence tomography angiography for the detection of neovascular age-related macular degeneration: a comprehensive multicentre diagnostic accuracy study in the UK-the ATHENA study.
Author
Niestrata, MagdalenaDeeks, Jonathan J
Takwoingi, Yemisi
Sivaprasad, Sobha
Patel, Praveen J
Keane, Pearse A
Kernohan, Ashleigh
Vale, Luke
Denniston, Alastair K
Gale, Richard
Khan, Adam R
McKinnon, William
Agarwal, Ridhi
de Salvo, Gabriella
Minos, Evangelos
Barbeiro, Paulo
Chakravarthy, Usha
Waheed, Nadia K
Madhusudhan, Savita
Peto, Tunde
Balaskas, Konstantinos
Publication date
2024-05-31Subject
Ophthalmology
Metadata
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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. Keywords: Medical retina; Ophthalmology.Citation
Niestrata M, Deeks JJ, Takwoingi Y, Sivaprasad S, Patel PJ, Keane PA, Kernohan A, Vale L, Denniston AK, Gale R, Khan AR, McKinnon W, Agarwal R, de Salvo G, Minos E, Barbeiro P, Chakravarthy U, Waheed NK, Madhusudhan S, Peto T, Balaskas K. Study protocol: optical coherence tomography angiography for the detection of neovascular age-related macular degeneration: a comprehensive multicentre diagnostic accuracy study in the UK-the ATHENA study. BMJ Open. 2024 May 31;14(5):e070857. doi: 10.1136/bmjopen-2022-070857. PMID: 38821570; PMCID: PMC11149127.Type
ArticleOther
PMID
38821570Journal
BMJ OpenPublisher
BMJ Publishing Groupae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2022-070857