ArticleBMJ open ophthalmology2024
Novel electroretinography devices to detect hydroxychloroquine retinopathy: study protocol for a diagnostic accuracy and feasibility study.
Article in BMJ open ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06035887 (A Feasibility Study Using Novel, Portable Electroretinography Devices to Detect Hydroxychloroquine Retinopathy), which is not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Feasibility Study Using Novel, Portable Electroretinography Devices to Detect Hydroxychloroquine Retinopathy
Who cites it
1 citing paper in PubMed.
- Novel electroretinography devices to detect hydroxychloroquine retinopathy: study protocol for a diagnostic accuracy and feasibility study.BMJ open ophthalmology · 2024Article
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAnnual 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.
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