Novel ERG for Detection of Hydroxychloroquine Retinopathy
Hydroxychloroquine is a drug used to treat conditions such as rheumatoid arthritis and systemic lupus erythematosus. Rarely, it can cause sight loss due to damage to the retina at the back of the eyes - because this process can be asymptomatic in the early stages, and the only way of preventing it getting worse is to stop the drug, it is highly advisable patients on hydroxychloroquine have their eyes screened for side effects. This study evaluates the use of two electroretinography devices in a novel, screening-based way to see if they can detect eye-related retinal side effects of hydroxychloroquine. The devices work by flashing light at the eyes in different patterns and sequences, and measuring the responses using skin sensors on the eyelids; they are non-invasive and low-risk. The results of the devices will be compared to standard scans taken of the back of the eyes. The study only involves a single visit, which takes about 2 hours. The only hospital recruiting on this study at present is King's College Hospital, so participants would have to be willing to travel to King's College Hospital for the study. We are looking for individuals who are taking hydroxychloroquine, or individuals who are known to have retinal side effects to hydroxychloroquine whether or not you are still taking the drug. We are also looking for healthy volunteers with no known eye disease who can provide reference comparisons to see that the devices work as intended. The main group of people we are looking for at this stage are those who have known retinal side effects due to hydroxychloroquine.
At a glance
What is this study about?
Hydroxychloroquine is a medicine commonly used in the UK to treat health conditions that cause inflammation, like certain types of arthritis. While it's very helpful for many people, in rare cases, it can lead to a side effect called retinopathy, which affects your eyesight. Because of this, people taking hydroxychloroquine need regular eye check-ups to catch any potential problems early. These check-ups usually happen at hospital eye clinics, but getting an appointment can sometimes be difficult due to how busy these clinics are.
This study is looking for better ways to screen for this eye problem. Currently, one of the best ways to test for it involves a method called electroretinography (ERG). This test measures the electrical signals in your eye's retina (the light-sensitive layer at the back of your eye) in response to flashes of light. While it's very good at finding retinopathy, the traditional ERG test can be uncomfortable, time-consuming, and requires special training to perform and understand.
That's why scientists are testing two new ERG devices which they hope will be much easier to use. These new devices are called the RETEval and the UTAS multifocal ERG. They are designed to be quicker, more comfortable (using sensors on the skin around your eye instead of on the eye itself), and don't always need eye drops to widen your pupils. The goal of this research is to see if these new machines can accurately detect and classify eye problems in people taking hydroxychloroquine, compared to the standard tests currently used. If successful, these new devices could make it much simpler for people to get their regular eye checks, perhaps even at their local optician or GP surgery, making screening more accessible.
Key takeaways
- New, easier eye tests are being developed for hydroxychloroquine users.
- These tests could make eye screening more comfortable and accessible.
- The study compares new devices with standard hospital eye checks.
- Participation involves eye tests, not taking new medicines.
- It aims to improve early detection of eye problems from hydroxychloroquine.
Who may be eligible?
You might be able to join this study if you are 18 years or older. For those taking hydroxychloroquine, you generally need to have been on the medication for more than 5 years. However, if you have certain risk factors for eye changes (like taking a high dose for your body weight, having kidney problems, or also taking a drug called tamoxifen), you might be eligible after 1 year on hydroxychloroquine.
If you haven't taken hydroxychloroquine before, you could also qualify to join the 'control group', which helps researchers compare results between people who have and haven't used the medication.
Unfortunately, you wouldn't be able to join if you have certain existing eye conditions, such as severe cataracts, recent cataract surgery, significant issues with the front or back of your eye (like advanced macular problems or glaucoma), or other conditions that might affect your vision or the accuracy of the tests. Also, if you're taking specific other medications, you might not be eligible. The research team will review your medical history carefully to make sure the study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been taking hydroxychloroquine for at least 5 years (or 1 year if you have certain risk factors)?
- Do you not have severe cataracts or other major existing eye problems?
- Are you not currently taking certain other specific medications?
- Are you able and willing to attend appointments for eye tests?
- Are you over 18?
- Are you on hydroxychloroquine, or are known to have retinal side effects to hydroxychloroquine?
- Are you known to have diabetes, sickle cell disease or epilepsy?
What does participation involve?
If you join this study, you will have several eye tests done. This includes the two new ERG devices (the handheld RETEval and the trolley-mounted UTAS multifocal ERG), as well as standard eye tests like Spectral-Domain Optical Coherence Tomography and Macular Autofluorescence. These tests involve flashing lights and taking pictures of your eye. You won't need to take any new medication as part of this study. The team will compare the results from the new devices with the standard tests. All assessments will be completed within a short period, typically during one or two hospital visits, and there is no long-term follow-up required after your initial assessments. The total duration of your participation will be limited to these initial study appointments.
Potential risks and benefits
Locations (1)
- King's College HospitalVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is hydroxychloroquine retinopathy?
It's a rare side effect of the medicine hydroxychloroquine that can affect the light-sensitive part of your eye, potentially impacting your vision if not detected and managed.
Who is developing these new eye test devices?
The new electroretinography devices, RETEval and UTAS multifocal ERG, are being developed by a company called LKC Technologies.
Will I get paid for being in the study?
The information provided does not mention payment for participation. It's best to confirm this directly with the study team.
Do I have to stop taking my hydroxychloroquine for the study?
No, you do not have to stop your medication to participate in this study. The study aims to test devices in people already taking hydroxychloroquine.
How long will my involvement in the study last?
Your participation will typically involve one or two appointments to complete all the necessary eye tests and assessments, with no long-term follow-up.
I have stopped taking hydroxychloroquine - can I still take part in this research?From the study team
If you have known retinal side effects to hydroxychloroquine, then yes we would be very interested in having you take part. If you are not known to have retinal side effects and are no longer taking hydroxychloroquine, at this stage you would not be eligible for this research trial.
Will I have eyedrops that blur my sight as part of the study?From the study team
Yes, eyedrops that open up the pupils (which are the same as those used in standard screening appointments, and other eye consultations) will be applied during the study visit. This can blur your near and distance sight for about 4-6 hours. You should not drive to this appointment.
How to find out more
Chan Ning Lee
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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