Novel ERG for Detection of Hydroxychloroquine Retinopathy

ConditionHydroxychloroquine Retinopathy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorKing's College Hospital NHS Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

No prior HCQ exposure

Disqualifiers

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.

Trial 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)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Hand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated)
Diagnostic test
RETEval Complete hand-held electroretinogram
Trolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated)
Diagnostic test
UTAS multifocal electroretinogram
Spectral-Domain Optical Coherence Tomography (Standard of Care test)
Diagnostic test
Heidelberg Engineering Spectralis Spectral-Domain Optical Coherence Tomography (macular structural scan)
Macular Autofluorescence (Standard of Care test)
Diagnostic test
Heidelberg Engineering Spectralis Autofluorescence imaging (macular structural image)

Treatment groups

140 Participants

are divided into 4 treatment groups

Group A: Normative Controls4 interventions

Group B: On Hydroxychloroquine, NO retinopathy4 interventions

Group C: On Hydroxychloroquine, POSSIBLE retinopathy4 interventions

Group D: On Hydroxychloroquine, DEFINITE retinopathy4 interventions

Trial outcomes

Primary outcomes

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

Primary Outcome

Time frame

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

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

Secondary Outcome

Time frame

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

Feasibility Outcome

Time frame

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.

Feasibility Outcome

Time frame

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

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

Exploratory Outcome

Time frame

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

Exploratory Outcome

Time frame

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College Hospital NHS Trust

Lead sponsor

LUPUS UK

Collaborator

King's College Hospital Charity

Collaborator

Source ClinicalTrials.gov

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