New devices for detecting eye damage from hydroxychloroquine
A Feasibility Study Using Novel, Portable Electroretinography Devices to Detect Hydroxychloroquine Retinopathy
This study is testing two new devices to see if they can better detect eye damage in people taking hydroxychloroquine for a long time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (London, London) |
| Trial ID | NCT06035887 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been on hydroxychloroquine for more than 5 years or more than 1 year with high-risk factors.
Not a fit: Patients with significant eye conditions such as advanced cataracts or severe macular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accessible and efficient screening for hydroxychloroquine retinopathy, improving patient outcomes.
How similar studies have performed: While the use of electroretinography is established, the specific application of these novel devices for hydroxychloroquine retinopathy detection is relatively new and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London, London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.