Novel ERG for Detection of Hydroxychloroquine Retinopathy
Research type
Research Study
Full title
A feasibility study using novel electroretinography devices to detect hydroxychloroquine (HCQ) retinopathy
IRAS ID
317611
Contact name
Timothy Jackson
Contact email
Sponsor organisation
King's College Hospital
Clinicaltrials.gov Identifier
R2023SP0113, Lupus UK Grant Funding
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of the study is to investigate novel electroretinography devices in the detection of hydroxychloroquine retinopathy.
Hydroxychloroquine is a widely used drug used to treat inflammatory disorders – most commonly rheumatoid arthritis and systemic lupus erythematosus. Although having many advantages in that it is effective, easy to take, and is well tolerated, one of the main side effects is a rare but significant risk of sight loss due to retinal damage (up to 7.5%). This is important because the area of sight loss is very near the centre of vision (which can affect one’s ability to work and drive) and is irreversible once it has occurred. The only way to prevent further loss of sight is to stop the drug.
The Royal College of Ophthalmologists has recommended that people on hydroxychloroquine (around 350,000 in the UK) are checked once a year for retinal damage, which involves putting in dilating eyedrops (which blur the vision) and taking scans of the back of the eye, which are interpreted by a specialist. This process can only realistically happen in hospital eye units, and significant challenges in capacity and funding have limited the uptake of screening nationally.
Electroretinography (ERG) is a retinal testing method that is considered a gold-standard to detect retinal abnormalities (including hydroxychloroquine retinopathy) but is limited to few hospitals as it is highly specialised, and is very laborious and uncomfortable for patients, necessitating approximately 30 minutes of testing per eye and the use of electrodes placed on the eye surface.
Newer electroretinography devices being evaluated in this study simplify this testing process, reducing the time taken, using skin (rather than eye-contact) electrodes, and being more portable (including a hand-held version) with automated interpretation software. If proven effective at detecting retinopathy, they could radically change screening, putting it in the hands of general clinicians.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0011
Date of REC Opinion
27 Feb 2024
REC opinion
Further Information Favourable Opinion