[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518849":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":47,"centralContacts":51,"locations":60,"responsibleParty":77,"collaborators":79,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":10,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":10,"enrollmentInfo":94,"targetDuration":10,"studyType":97,"phases":10,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",[8,17,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Normative Controls",null,"Age- and sex- matched normal controls",[13,14,15,16],"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)",{"label":18,"type":10,"description":19,"interventionNames":20},"On Hydroxychloroquine, NO retinopathy","Participants over 18 years on hydroxychloroquine without hydroxychloroquine-related retinopathy",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"On Hydroxychloroquine, POSSIBLE retinopathy","Participants over 18 years on hydroxychloroquine with possible (indeterminate) hydroxychloroquine-related retinopathy",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"On Hydroxychloroquine, DEFINITE retinopathy","Participants over 18 years on hydroxychloroquine with definite hydroxychloroquine-related retinopathy",[13,14,15,16],[30,35,39,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"DIAGNOSTIC_TEST","Hand-Held Full-Field Skin-Electrode Electroretinography (Device to be evaluated)","RETEval Complete hand-held electroretinogram",[9,26,18,22],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Trolley-Mounted Multifocal Skin-Electrode Electroretinography (Device to be evaluated)","UTAS multifocal electroretinogram",[9,26,18,22],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"Spectral-Domain Optical Coherence Tomography (Standard of Care test)","Heidelberg Engineering Spectralis Spectral-Domain Optical Coherence Tomography (macular structural scan)",[9,26,18,22],{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"Macular Autofluorescence (Standard of Care test)","Heidelberg Engineering Spectralis Autofluorescence imaging (macular structural image)",[9,26,18,22],[48],{"name":49,"affiliation":5,"role":50},"Professor Timothy L Jackson","STUDY_CHAIR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":10,"email":56},"Dr Chan Ning Lee","CONTACT","020 3299 1297","channing.lee2@nhs.net",{"name":58,"role":54,"phone":55,"phoneExt":10,"email":59},"Ophthalmology research inbox","kch-tr.ophthalmologyresearch@nhs.net",[61],{"facility":62,"status":63,"city":64,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"King's College Hospital","RECRUITING","London","SE5 9RS","United Kingdom","UK",{"type":69,"coordinates":70},"Point",[71,72],-0.12574,51.50853,{"lat":72,"lon":71},[75,76],{"name":53,"role":54,"phone":10,"phoneExt":10,"email":56},{"name":58,"role":54,"phone":10,"phoneExt":10,"email":59},{"type":78,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[80,83],{"name":81,"class":82},"LUPUS UK","UNKNOWN",{"name":84,"class":82},"King's College Hospital Charity","100518849","novel-erg-for-detection-of-hydroxychloroquine-retinopathy-100518849",false,"NCT06035887","Novel ERG for Detection of Hydroxychloroquine Retinopathy","A Feasibility Study Using Novel, Portable Electroretinography Devices to Detect Hydroxychloroquine Retinopathy","Inclusion Criteria:\n\n1. Age ≥18 years\n2. HCQ groups:\n\n   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\u002Fkg per day actual body weight (ABW) ii. Estimated glomerular filtration rate (eGFR) of \\\u003C60mls\u002Fmin\u002F1.73m2 iii. Concomitant tamoxifen use\n3. Control group:\n\n   1. No prior HCQ exposure\n\nExclusion Criteria:\n\n1. Cataract grade ≥3 of any subtype\n2. Recent cataract surgery within 4 weeks of recruitment\n3. 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).\n4. Significant macular co-pathology including, but not limited to, macular degeneration, macular scarring, cystic macular oedema (for any reason), staphyloma.\n5. Inherited retinal and\u002For macular dystrophies including colour vision deficiencies\n6. Active or previous posterior uveitis or pan-uveitis\n7. Aphakia\n8. High refractive error \\>6.00 dioptres\n9. Amblyopia\n10. Diabetes\n11. Retinal angiopathies including, but no limited to, retinal vein occlusion, retinal artery occlusion, ocular ischaemic syndrome, HIV retinopathy, Sickle cell disease, radiation retinopathy\n12. Visually significant surgical retinal disease including epiretinal membrane, macular hole, retinal detachment, retinal tear\n13. Previous retinal laser or intravitreal treatment\n14. Moderate or worse glaucoma\n15. Optic atrophy\n16. Photosensitive epilepsy\n17. Ungradable HCQ retinopathy screening images\n18. Periocular infection or rash (recruitment can be deferred until acute pathology has resolved)\n19. Unable or unwilling to undertake study activities\n20. Any active use or history of the following medications:\n\nAmiodarone Canthaxanthin Deferoxamine Digoxin Ethambutol Interferon-alpha Melatonin Nefazodone Sildenafil Vigabatrin Chloroquine Quinine","ALL","18 Years",{"count":95,"type":96},140,"ESTIMATED","OBSERVATIONAL","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.",[100],"Hydroxychloroquine Retinopathy",[102,103],"Electroretinography","Diagnostic Evaluation","2025-08-01",{"date":106,"type":107},"2025-08-06","ACTUAL",{"date":109,"type":107},"2024-05-31",{"date":111,"type":96},"2026-05",{"name":5,"class":6},1]