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
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 design
Treatments tested in this trial
- Hand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated)
- Trolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated)
- Spectral-Domain Optical Coherence Tomography (Standard of Care test)
- Macular Autofluorescence (Standard of Care test)
Treatment groups
140 Participants
are divided into 4 treatment groupsSponsors and collaborators
King's College Hospital NHS Trust
Lead sponsor
LUPUS UK
Collaborator
King's College Hospital Charity
Collaborator
Source ClinicalTrials.gov