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RecruitingNCT06035887

Novel ERG for Detection of Hydroxychloroquine Retinopathy

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

Sponsor

King's College Hospital NHS Trust

Enrollment

140 participants

Start Date

May 31, 2024

Study Type

OBSERVATIONAL

Conditions

Hydroxychloroquine Retinopathy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria21

  • 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
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Interventions

DIAGNOSTIC_TESTHand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated)

RETEval Complete hand-held electroretinogram

DIAGNOSTIC_TESTTrolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated)

UTAS multifocal electroretinogram

DIAGNOSTIC_TESTSpectral-Domain Optical Coherence Tomography (Standard of Care test)

Heidelberg Engineering Spectralis Spectral-Domain Optical Coherence Tomography (macular structural scan)

DIAGNOSTIC_TESTMacular Autofluorescence (Standard of Care test)

Heidelberg Engineering Spectralis Autofluorescence imaging (macular structural image)

Locations(1)

King's College Hospital

London, London, United Kingdom

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NCT06035887

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