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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Chan Ning
Lee
channing.lee@doctors.org.uk
Mr
Tim
Jackson
t.jackson1@nhs.net
Chan Ning
Lee
channing.lee@doctors.org.uk
Disorders of choroid and retinaInflammatory polyarthropathiesSystemic connective tissue disordersDrugs, medicaments and biological substances causing adverse effects in therapeutic use
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The purpose of the study is to investigate novel electroretinography devices in the detection of hydroxychloroquine retinopathy.
Hydroxychloroquine is a widely used drug used to treat inflammatory disorders – most commonly rheumatoid arthritis and systemic lupus erythematosus. Although having many advantages in that it is effective, easy to take, and is well tolerated, one of the main side effects is a rare but significant risk of sight loss due to retinal damage (up to 7.5%). This is important because the area of sight loss is very near the centre of vision (which can affect one’s ability to work and drive) and is irreversible once it has occurred. The only way to prevent further loss of sight is to stop the drug.
The Royal College of Ophthalmologists has recommended that people on hydroxychloroquine (around 350,000 in the UK) are checked once a year for retinal damage, which involves putting in dilating eyedrops (which blur the vision) and taking scans of the back of the eye, which are interpreted by a specialist. This process can only realistically happen in hospital eye units, and significant challenges in capacity and funding have limited the uptake of screening nationally.
Electroretinography (ERG) is a retinal testing method that is considered a gold-standard to detect retinal abnormalities (including hydroxychloroquine retinopathy) but is limited to few hospitals as it is highly specialised, and is very laborious and uncomfortable for patients, necessitating approximately 30 minutes of testing per eye and the use of electrodes placed on the eye surface.
Newer electroretinography devices being evaluated in this study simplify this testing process, reducing the time taken, using skin (rather than eye-contact) electrodes, and being more portable (including a hand-held version) with automated interpretation software. If proven effective at detecting retinopathy, they could radically change screening, putting it in the hands of general clinicians.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Device;
You can take part if:
You may not be able to take part if:
1. Cataract grade > = 3 of any subtype 2. 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 > 8.00 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 pathology including epiretinal membrane, macular holes, retinal detachment, retinal tears 13. Previous retinal laser, retinal surgery or intravitreal treatment 14. Primary or secondary glaucoma with established neuroretinal rim thinning, uncontrolled IOP of  24 millimeters of mercury or mean deviation of -6.00 decibels or greater. 15. Optic atrophy 16. Photosensitive epilepsy 17. Ungradable HCQ retinopathy screening images 18. Periocular infection or rash (recruitment can be deferred until acute disease has resolved) 19. Unable or unwilling to undertake study activities 20. Light-adapted, undilated pupil size > 6mm diameter or < 2mm diameter 21. Current or previous use of any medication detailed in Table 1 Table 1 – Prohibited Medications Amiodarone Canthaxanthin Deferoxamine Digoxin Ethambutol Interferon-alpha Melatonin Nefazodone Sildenafil Vigabatrin Chloroquine Quinine
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Tim
Jackson
t.jackson1@nhs.net
Chan Ning
Lee
channing.lee@doctors.org.uk
Chan Ning
Lee
channing.lee@doctors.org.uk
The study is sponsored by King's College London and funded by Lupus UK; King's College Hospital Charity; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 55679
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