NCT06035887

Novel ERG for Detection of Hydroxychloroquine Retinopathy

A Feasibility Study Using Novel, Portable Electroretinography Devices to Detect Hydroxychloroquine Retinopathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of the study is to investigate novel electroretinography (ERG) devices in the detection of hydroxychloroquine retinopathy. Two devices (the RETEval full-field and flicker ERG and UTAS multifocal ERG) will be evaluated in this study, comparing device outputs to standard of care screening tests, in groups of participants characterised by presence or absence of hydroxychloroquine-related retinopathy.

Detailed description

Hydroxychloroquine (HCQ) is a widely used drug used to treat disorders of inflammation in the body with up to 320,000 people estimated to be on this drug in the UK alone. Retinopathy due to HCQ is a significant problem, necessitating yearly screening which can only realistically take place in hospital eye units where funding and capacity constraints limit the provision of services. Electroretinography is a non-invasive method of testing for eye retinal problems, which works by flashing light (in certain patterns and brightness) into eyes and measuring the electrical response through fine wires placed on the eye surface or behind the eyelid, and is considered by many authors to be a gold-standard test to detect HCQ retinopathy. Their use has been limited due to the high expertise required to undertake and interpret tests, limited availability of testing, and high test burden, however newer electroretinography devices have been developed by a company called LKC Technologies, which are faster to perform, use leads placed on the skin (rather than the eye surface) which are more comfortable, easier to use by healthcare technicians, and can be done without the need for dilating eyedrops. The two devices being tested in this study are: * The RETEval = a handheld electroretinography testing device * The UTAS multifocal ERG = a trolley-mounted electroretinography testing device These innovations may make testing far easier to develop in both hospital eye service, and potentially even general settings such as outpatient clinics, general practices, and optometrists. This study aims to evaluate the performance of devices to detect and classify participants in 4 main groups: * Normative control participants (n=35) * Patients taking HCQ but without retinopathy (n=35) * Patients taking HCQ with indeterminate features of retinopathy (also known as POSSIBLE retinopathy) (n=35) * Patients taking HCQ with definite retinopathy Device outputs will be analysed and compared with masked graded screening results (incorporating spectral-domain macular optical coherence tomography and autofluorescence as standard, taken on the same visit) to generate device- and device-output-specific sensitivities and specificities. If a signal is found, the feasibility outcomes from this study will inform the study methodology and timelines for a larger trial if necessary.

Conditions

• Hydroxychloroquine Retinopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated)	RETEval Complete hand-held electroretinogram
DIAGNOSTIC_TEST	Trolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated)	UTAS multifocal electroretinogram
DIAGNOSTIC_TEST	Spectral-Domain Optical Coherence Tomography (Standard of Care test)	Heidelberg Engineering Spectralis Spectral-Domain Optical Coherence Tomography (macular structural scan)
DIAGNOSTIC_TEST	Macular Autofluorescence (Standard of Care test)	Heidelberg Engineering Spectralis Autofluorescence imaging (macular structural image)

Timeline

• Start date: 2024-05-31
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-09-13
• Last updated: 2025-08-06

Locations

1 site across 1 country: United Kingdom