Active not recruitingPHASE2INTERVENTIONAL

Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom

The CHAMP UK study is investigating if low-dose atropine eye drops can help stop short-sightedness (myopia) from getting worse in children. Myopia makes distant objects appear blurred and happens when the eye grows too long. While glasses correct vision, they don't stop the eyes from becoming more short-sighted. This study will involve 289 children aged 6 to 12. Some will receive the atropine eye drops, and others will get 'dummy' drops (placebo). Neither the child nor the research team will know who is getting what treatment to ensure fair results. The aim is to see if these drops can effectively slow down the progression of myopia as children grow.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Belfast Health and Social Care Trust

Enrolment target

289

Start

03 Apr 2019

Estimated completion

02 Feb 2027

Myopia

What is this study about?

If you or your child wears glasses for `short-sightedness`, also known as `myopia`, you'll know that it makes faraway objects look blurry. This happens because the eye grows a little too long, which is quite common, especially while children are growing taller. Glasses or contact lenses help you see clearly, but they don't usually stop the eyes from becoming more short-sighted over time.

The CHAMP UK study is a new research project looking into a type of eye drop that might help. These drops contain a medicine called `atropine`, but in a very low dose. The scientists want to find out if using these drops can prevent children's short-sightedness from getting worse as they get older. If successful, this could be a really helpful way to manage myopia in the future.

This study is carefully designed to make sure the results are reliable. It's a `randomised controlled trial`, which means children will be randomly chosen to receive either the atropine eye drops or dummy drops (called `placebo`). Importantly, neither the children nor the study team will know who is getting which drops (`double masked`). This helps prevent anyone's expectations from influencing the results. The study aims to compare how the vision changes in both groups to see if the atropine drops make a real difference.

Key takeaways

The study investigates if low-dose atropine eye drops can slow down children's short-sightedness.
It involves children aged 6 to 12 with short-sightedness.
Participants will be randomly given either the study drops or inactive 'dummy' drops.
Dose is once daily for two years.
Neither the child nor the research team knows who gets which drops.
The goal is to find better ways to manage short-sightedness in children.

Who may be eligible?

This study is looking for children aged between 6 and 12 years old who have short-sightedness (myopia). To be considered, your child needs to have a certain level of short-sightedness in both eyes, but not an extreme level, and their vision must be correctable to a good standard with glasses or contact lenses.

There are also some reasons why a child might not be able to join the study. For example, if they have other eye conditions, very severe short-sightedness, or a significant curvature of the eye (called astigmatism), they wouldn't be able to take part. Children with conditions like a 'lazy eye' (amblyopia) or other major health problems that could make attending appointments difficult would also not be eligible.

To ensure everyone understands the study well, both parents and children need to have a good understanding of English. If your child is already part of another medical study or has an allergy to atropine or similar medicines, they also wouldn't be able to participate.

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.

Is your child aged between 6 and 12 years?
Does your child have short-sightedness (myopia) in both eyes?
Does your child *not* have other serious eye conditions?
Is your child *not* already in another medical research study?
Does your child *not* have any known allergy to atropine?
Do you and your child understand English well enough to follow study instructions?

Answer every question to see your result.

What does participation involve?

If your child is invited to take part, the first step is a `screening visit`. This is like a detailed eye check-up to make sure they are suitable for the study. You and your child will be asked to sign consent forms, making sure you both understand what's involved.

During this visit, a number of standard eye tests will be done, similar to what you might have at an optician. This includes checking near and distant vision and taking measurements of the eye. Some drops will be put into your child's eyes; these temporarily make pupils larger and can make close-up vision blurry for a few hours and eyes more sensitive to light for up to a day. You'll also be asked about your child's daily habits, like screen time and reading habits.

If eligible, your child will use one eye drop in each eye, once a day, for `24 months` (two years). You'll be given clear instructions on how to do this. Throughout the study, there will be regular follow-up appointments at one of the research centres to monitor your child's eyes and answer any questions you have.

Potential risks and benefits

If your child takes part, a potential benefit is that the low-dose atropine eye drops might help slow down the progression of their short-sightedness. This could mean they need weaker glasses in the future or that their vision stabilises better than it might have otherwise. However, it's also possible that the drops will have no effect or that your child receives the dummy drops. The eye drops used for assessments may cause temporary blurred close-up vision and light sensitivity. You are free to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northern Ireland Clinical Research
Verified postcode
Belfast, United Kingdom
Aston University Eye Clinic
Verified postcode
Birmingham, United Kingdom
Anglia Ruskin University Eye Clinic
Verified postcode
Cambridge, United Kingdom
Centre for Living (Glasgow Caledonian University)
Verified postcode
Glasgow, United Kingdom

Common questions

What is myopia?

Myopia is the medical term for short-sightedness, where distant objects look blurry because the eye grows too long.

What are atropine eye drops for?

Low-dose atropine eye drops are being studied to see if they can help slow down the worsening of short-sightedness in children.

Will my child get the actual drops or a dummy (placebo) drop?

Children will be randomly assigned to receive either the atropine eye drops or a dummy drop, and neither you nor the study team will know which for fairness.

How long will my child need to use the eye drops?

If selected for the study, your child will use one eye drop in each eye every day for two years (24 months).

Are there side effects of the eye drops used for assessment?

Yes, some drops used for initial checks can temporarily make your child's pupils larger, cause blurry close-up vision for a few hours, and make eyes more sensitive to light.