Novel ERG for Detection of Hydroxychloroquine Retinopathy

NCT06035887 | Recruiting

• 1 other identifier: IRAS 317611
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hydroxychloroquine Retinopathy

Keywords

Electroretinography; Diagnostic Evaluation

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of both devices to discriminate between NO, POSSIBLE and DEFINITE hydroxychloroquine retinopathy compared to standard screening tests

  Primary Outcome

  All tests required to determine sensitivity and specificity of both devices compared to standard retinal imaging will be completed in a single visit. Safety will be evaluated up to 1 week post-visit.

Secondary Outcomes (3)

• To compare the sensitivity and specificity of undilated versus dilated testing with the multifocal ERG device, for all categories of hydroxychloroquine retinopathy

  All tests required to determine this outcome will be completed at a single visit. Safety will be evaluated up to 1 week post-visit.

• To determine the patient acceptability of both devices evaluated using standardised, study-specific questionnaires

  All tests required to determine this outcome will be completed at a single visit. Safety will be evaluated up to 1 week post-visit.

• To determine the proportion and recruitment rate of patients in each category of hydroxychloroquine retinopathy who consent to join this study.

  All tests required to determine this outcome will be completed at a single visit. Safety will be evaluated up to 1 week post-visit.

Other Outcomes (2)

• To determine which ERG waveform features (such as implicit time or amplitude) from both devices best discriminate participants with NO hydroxychloroquine retinopathy from those with POSSIBLE and DEFINITE hydroxychloroquine retinopathy

  All tests required to determine this outcome will be completed at a single visit. Safety will be evaluated up to 1 week post-visit.

• To determine if both device waveforms correlate with standard mfERG waveforms in patients receiving hydroxychloroquine

  All tests required to determine this outcome will be completed at a single visit. Novel device ERG waveforms will be compared with standard mfERG where undertaken in the preceding 12 months. Safety will be evaluated up to 1 week post-visit.

Study Arms (4)

Normative Controls

Age- and sex- matched normal controls

Diagnostic Test: Hand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated); Diagnostic Test: Trolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated); Diagnostic Test: Spectral-Domain Optical Coherence Tomography (Standard of Care test); Diagnostic Test: Macular Autofluorescence (Standard of Care test)

On Hydroxychloroquine, NO retinopathy

Participants over 18 years on hydroxychloroquine without hydroxychloroquine-related retinopathy

Diagnostic Test: Hand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated); Diagnostic Test: Trolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated); Diagnostic Test: Spectral-Domain Optical Coherence Tomography (Standard of Care test); Diagnostic Test: Macular Autofluorescence (Standard of Care test)

On Hydroxychloroquine, POSSIBLE retinopathy

Participants over 18 years on hydroxychloroquine with possible (indeterminate) hydroxychloroquine-related retinopathy

Diagnostic Test: Hand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated); Diagnostic Test: Trolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated); Diagnostic Test: Spectral-Domain Optical Coherence Tomography (Standard of Care test); Diagnostic Test: Macular Autofluorescence (Standard of Care test)

On Hydroxychloroquine, DEFINITE retinopathy

Participants over 18 years on hydroxychloroquine with definite hydroxychloroquine-related retinopathy

Diagnostic Test: Hand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated); Diagnostic Test: Trolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated); Diagnostic Test: Spectral-Domain Optical Coherence Tomography (Standard of Care test); Diagnostic Test: Macular Autofluorescence (Standard of Care test)

Interventions

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

RETEval Complete hand-held electroretinogram

Normative Controls; On Hydroxychloroquine, DEFINITE retinopathy; On Hydroxychloroquine, NO retinopathy; On Hydroxychloroquine, POSSIBLE retinopathy

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

UTAS multifocal electroretinogram

Normative Controls; On Hydroxychloroquine, DEFINITE retinopathy; On Hydroxychloroquine, NO retinopathy; On Hydroxychloroquine, POSSIBLE retinopathy

Spectral-Domain Optical Coherence Tomography (Standard of Care test) DIAGNOSTIC_TEST

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

Normative Controls; On Hydroxychloroquine, DEFINITE retinopathy; On Hydroxychloroquine, NO retinopathy; On Hydroxychloroquine, POSSIBLE retinopathy

Macular Autofluorescence (Standard of Care test) DIAGNOSTIC_TEST

Heidelberg Engineering Spectralis Autofluorescence imaging (macular structural image)

Normative Controls; On Hydroxychloroquine, DEFINITE retinopathy; On Hydroxychloroquine, NO retinopathy; On Hydroxychloroquine, POSSIBLE retinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age- and sex-matched control group (n=35) On hydroxychloroquine without retinopathy (n=35) On hydroxychloroquine with possible retinopathy (n=35) On hydroxychloroquine with definite retinopathy (n=35)

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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• LUPUS UK: collaborator
• King's College Hospital Charity: collaborator

Study Sites (1)

King's College Hospital

London, London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (1)

• Lee CN, Wafa HA, Murphy G, Galloway J, Mahroo OA, Jackson TL. Novel electroretinography devices to detect hydroxychloroquine retinopathy: study protocol for a diagnostic accuracy and feasibility study. BMJ Open Ophthalmol. 2024 Dec 24;9(1):e001898. doi: 10.1136/bmjophth-2024-001898.

  PMID: 39719323 DERIVED

Study Officials

• Professor Timothy L Jackson

  King's College Hospital NHS Trust

  STUDY CHAIR

Central Study Contacts

Dr Chan Ning Lee

CONTACT

020 3299 1297; channing.lee2@nhs.net

Ophthalmology research inbox

CONTACT

020 3299 1297; kch-tr.ophthalmologyresearch@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: May 31, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

GB (1)