Actively Recruiting
Novel ERG for Detection of Hydroxychloroquine Retinopathy
Led by King's College Hospital NHS Trust · Updated on 2025-08-06
140
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
K
King's College Hospital NHS Trust
Lead Sponsor
L
LUPUS UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel ERG for Detection of Hydroxychloroquine Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For HCQ users without high-risk factors, HCQ use for more than 5 years
- For HCQ users with one or more high-risk factors (dose >5mg/kg/day actual body weight, eGFR <60mls/min/1.73m2, or concomitant tamoxifen use), HCQ use for more than 1 year
- Control group participants must have no prior HCQ exposure
You will not qualify if you...
- Cataract grade 3 or higher of any subtype
- Cataract surgery within 4 weeks before recruitment
- Significant media opacity or corneal disease including corneal oedema, scarring, keratoconus, previous corneal transplants, or severe keratoconjunctivitis sicca requiring special treatment
- Significant macular co-pathology including macular degeneration, scarring, cystic macular oedema, or staphyloma
- Inherited retinal or macular dystrophies including color vision deficiencies
- Active or previous posterior or pan-uveitis
- Aphakia (absence of the lens)
- High refractive error over 6.00 dioptres
- Amblyopia
- Diabetes
- Retinal angiopathies such as retinal vein or artery occlusion, ocular ischemic syndrome, HIV retinopathy, Sickle cell disease, or radiation retinopathy
- Visually significant surgical retinal disease including epiretinal membrane, macular hole, retinal detachment, or retinal tear
- Previous retinal laser or intravitreal treatment
- Moderate or worse glaucoma
- Optic atrophy
- Photosensitive epilepsy
- Ungradable HCQ retinopathy screening images
- Periocular infection or rash (recruitment deferred until resolved)
- Unable or unwilling to participate in study activities
- Current or past use of medications including Amiodarone, Canthaxanthin, Deferoxamine, Digoxin, Ethambutol, Interferon-alpha, Melatonin, Nefazodone, Sildenafil, Vigabatrin, Chloroquine, or Quinine
AI-Screening
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Trial Site Locations
Total: 1 location
1
King's College Hospital
London, London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
D
Dr Chan Ning Lee
CONTACT
O
Ophthalmology research inbox
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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