Novel ERG for Detection of Hydroxychloroquine Retinopathy
Recruiting now
Conditions studied: Hydroxychloroquine Retinopathy
In brief
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.
Key facts
- Study ID
- NCT06035887
- Run by
- King's College Hospital NHS Trust
- People needed
- 140
- Starts
- 2024-05-31
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- HCQ groups:
- a. HCQ use >5 years for patients without any high-risk factors, or >1 year in patients with one or more high-risk factors for HCQ retinopathy, namely: i. Dose >5mg/kg per day actual body weight (ABW) ii. Estimated glomerular filtration rate (eGFR) of <60mls/min/1.73m2 iii. Concomitant tamoxifen use
- Control group:
- No prior HCQ exposure
You may not qualify if…
- Cataract grade ≥3 of any subtype
- Recent cataract surgery within 4 weeks of recruitment
- Significant media opacity or corneal disease including, but not limited to, corneal oedema, corneal scarring, keratoconus, previous corneal transplants, severe keratoconjunctivitis sicca (requiring the use of topical serum, immunosuppressive or analogous therapy, or procedural treatment).
- Significant macular co-pathology including, but not limited to, macular degeneration, macular scarring, cystic macular oedema (for any reason), staphyloma.
- Inherited retinal and/or macular dystrophies including colour vision deficiencies
- Active or previous posterior uveitis or pan-uveitis
- Aphakia
- High refractive error >6.00 dioptres
- Amblyopia
- Diabetes
- Retinal angiopathies including, but no limited to, retinal vein occlusion, retinal artery occlusion, ocular ischaemic syndrome, HIV retinopathy, Sickle cell disease, radiation retinopathy
- Visually significant surgical retinal disease including epiretinal membrane, macular hole, retinal detachment, 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 can be deferred until acute pathology has resolved)
- Unable or unwilling to undertake study activities
- Any active use or history of the following medications:
- Amiodarone Canthaxanthin Deferoxamine Digoxin Ethambutol Interferon-alpha Melatonin Nefazodone Sildenafil Vigabatrin Chloroquine Quinine
Where it is running
- King's College Hospital — London, London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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