RecruitingOBSERVATIONAL

Novel ERG for Detection of Hydroxychloroquine Retinopathy

This study is testing new, more comfortable devices to check for eye damage (retinopathy) that can be caused by a widely used drug called hydroxychloroquine. This drug is often prescribed for conditions that cause inflammation. Currently, checking for this eye damage often requires specialist hospital visits and can be difficult to arrange. The new devices are called RETEval and UTAS multifocal ERG. They aim to make eye checks quicker and more convenient, possibly even in local clinics or opticians. Researchers will compare how well these new machines detect eye changes against the standard hospital tests in people who take the drug, with and without eye problems, and those who don't take the drug.

At a glance

Status

Recruiting

Sponsor

King's College Hospital NHS Trust

Enrolment target

140

Start

31 May 2024

Estimated completion

01 May 2026

Hydroxychloroquine Retinopathy

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.

Quick self-check

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?

This is a guide only — the research team will confirm whether you can take part.

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

Participating in this study might offer the benefit of having comprehensive eye examinations by specialists, which could detect any early signs of eye problems you might not yet be aware of. While the new devices are designed to be more comfortable, some people might find the bright lights during the eye tests slightly uncomfortable or experience temporary blurred vision from eye drops, although these effects typically wear off quickly. There are no known serious risks associated with the eye tests themselves. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

King's College Hospital
London, 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.

How to find out more

Dr Chan Ning Lee

channing.lee2@nhs.net 020 3299 1297 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.