TY - JOUR
T1 - Novel electroretinography devices to detect hydroxychloroquine retinopathy
T2 - study protocol for a diagnostic accuracy and feasibility study
AU - Lee, Chan Ning
AU - Wafa, Hatem A
AU - Murphy, George
AU - Galloway, James
AU - Mahroo, Omar A
AU - Jackson, Timothy L
N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/12/24
Y1 - 2024/12/24
N2 - INTRODUCTION: Annual screening for hydroxychloroquine (HCQ) retinopathy is recommended, and electroretinography (ERG) is considered a gold-standard test, but there are screening shortfalls and standard ERG is burdensome and has limited availability. Newer, portable ERG devices using skin-based electrodes may increase screening capacity but need validation. This study aims to determine initial device accuracies and feasibility of further research.METHODS AND ANALYSIS: Prospective diagnostic device accuracy and feasibility study comparing novel ERG devices to standard screening tests. Three groups of 35 participants on HCQ, categorised by HCQ retinopathy (definite, possible and no retinopathy), and 35 healthy control participants, recruited by consecutive sampling, will have full field and multifocal ERG index tests, delivered using skin-contact electrodes by two devices-RETEval full-field and UTAS multifocal ERG, both manufactured by LKC Technologies (Gaithersburg, Maryland, USA), compared with spectral-domain optical coherence tomography and autofluorescence reference tests graded by two masked, independent retinal specialists. Eligible HCQ participants will either have diagnosed HCQ retinopathy or be eligible for screening per UK guidelines. Healthy control participants will have no prior HCQ exposure and be of similar age and sex to HCQ participants. Primary outcome is device-specific sensitivity and specificity. Secondary outcomes include the effect of dilation on device outputs, analysis of discriminatory waveforms, device acceptability and recruitment rate. Safety outcomes include adverse and serious adverse events and device events.ETHICS AND DISSEMINATION: Cambridge East ethics committee gave a favourable opinion (24/EE/0011, 23/02/2024). Results will be published in a peer-reviewed ophthalmology journal.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06035887.
AB - INTRODUCTION: Annual screening for hydroxychloroquine (HCQ) retinopathy is recommended, and electroretinography (ERG) is considered a gold-standard test, but there are screening shortfalls and standard ERG is burdensome and has limited availability. Newer, portable ERG devices using skin-based electrodes may increase screening capacity but need validation. This study aims to determine initial device accuracies and feasibility of further research.METHODS AND ANALYSIS: Prospective diagnostic device accuracy and feasibility study comparing novel ERG devices to standard screening tests. Three groups of 35 participants on HCQ, categorised by HCQ retinopathy (definite, possible and no retinopathy), and 35 healthy control participants, recruited by consecutive sampling, will have full field and multifocal ERG index tests, delivered using skin-contact electrodes by two devices-RETEval full-field and UTAS multifocal ERG, both manufactured by LKC Technologies (Gaithersburg, Maryland, USA), compared with spectral-domain optical coherence tomography and autofluorescence reference tests graded by two masked, independent retinal specialists. Eligible HCQ participants will either have diagnosed HCQ retinopathy or be eligible for screening per UK guidelines. Healthy control participants will have no prior HCQ exposure and be of similar age and sex to HCQ participants. Primary outcome is device-specific sensitivity and specificity. Secondary outcomes include the effect of dilation on device outputs, analysis of discriminatory waveforms, device acceptability and recruitment rate. Safety outcomes include adverse and serious adverse events and device events.ETHICS AND DISSEMINATION: Cambridge East ethics committee gave a favourable opinion (24/EE/0011, 23/02/2024). Results will be published in a peer-reviewed ophthalmology journal.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06035887.
KW - Adult
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Antirheumatic Agents/adverse effects
KW - Electroretinography/methods
KW - Feasibility Studies
KW - Hydroxychloroquine/adverse effects
KW - Prospective Studies
KW - Reproducibility of Results
KW - Retina/drug effects
KW - Retinal Diseases/chemically induced
KW - Sensitivity and Specificity
KW - Tomography, Optical Coherence
KW - Observational Studies as Topic
U2 - 10.1136/bmjophth-2024-001898
DO - 10.1136/bmjophth-2024-001898
M3 - Article
C2 - 39719323
SN - 2397-3269
VL - 9
JO - BMJ Open Ophthalmology
JF - BMJ Open Ophthalmology
IS - 1
ER -