New devices for detecting eye damage from hydroxychloroquine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of two novel electroretinography devices in detecting hydroxychloroquine retinopathy, a condition affecting patients on long-term hydroxychloroquine treatment. Participants will be grouped based on their history of hydroxychloroquine use and the presence of retinopathy. The study compares the outputs of these new devices to standard screening tests, aiming to improve detection methods that are currently limited by expertise and accessibility. The devices being evaluated are the RETEval, a handheld device, and the UTAS multifocal ERG, a trolley-mounted device, both designed to simplify the testing process.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years
2. 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
3. Control group:

   1. No prior HCQ exposure

Exclusion Criteria:

1. Cataract grade ≥3 of any subtype
2. Recent cataract surgery within 4 weeks of recruitment
3. 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).
4. Significant macular co-pathology including, but not limited to, macular degeneration, macular scarring, cystic macular oedema (for any reason), staphyloma.
5. Inherited retinal and/or macular dystrophies including colour vision deficiencies
6. Active or previous posterior uveitis or pan-uveitis
7. Aphakia
8. High refractive error \>6.00 dioptres
9. Amblyopia
10. Diabetes
11. Retinal angiopathies including, but no limited to, retinal vein occlusion, retinal artery occlusion, ocular ischaemic syndrome, HIV retinopathy, Sickle cell disease, radiation retinopathy
12. Visually significant surgical retinal disease including epiretinal membrane, macular hole, retinal detachment, retinal tear
13. Previous retinal laser or intravitreal treatment
14. Moderate or worse glaucoma
15. Optic atrophy
16. Photosensitive epilepsy
17. Ungradable HCQ retinopathy screening images
18. Periocular infection or rash (recruitment can be deferred until acute pathology has resolved)
19. Unable or unwilling to undertake study activities
20. Any active use or history of the following medications:

Amiodarone Canthaxanthin Deferoxamine Digoxin Ethambutol Interferon-alpha Melatonin Nefazodone Sildenafil Vigabatrin Chloroquine Quinine

Where it's running

• King's College Hospital
  London, London, United Kingdom Recruiting

Study contacts

• Study coordinator: Dr Chan Ning Lee
• Email: channing.lee2@nhs.net
• Phone: 020 3299 1297

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.