CompletedPhase IIInterventional

Low-dose atropine eye drops to reduce progression of short-sightedness (myopia) in children in the United Kingdom

Short-sightedness, also called myopia, makes distant objects look blurry. It happens when the eye grows slightly too long, which often happens as children grow taller. Glasses and contact lenses help children see clearly, but they cannot stop the eyes from becoming more short-sighted over time. Severe short-sightedness can lead to serious eye problems later in adult life. This UK study is finding out whether using gentle, low-dose atropine eye drops once a day can slow down this change in children aged 6 to 12. Children taking part use either atropine drops or dummy drops (which only moisten the eyes) for two years. They also attend regular hospital check-ups every six months. The aim is to discover whether these drops are a safe and effective way to protect children's vision for the future.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Belfast Health and Social Care Trust

Enrolment target

289

Start

03 Apr 2019

Estimated completion

18 Feb 2022

Myopia

What is this study about?

Short-sightedness, known medically as myopia, is very common. It makes objects in the distance, like a classroom whiteboard or television, look out of focus. This happens when the eyeball grows slightly longer than normal from front to back, which usually occurs while children are growing taller. While glasses and contact lenses help bend light so children can see clearly, they do not stop the eye from continuing to stretch and become more short-sighted.

Having higher levels of short-sightedness is not just an inconvenience. In adulthood, it can increase the risk of developing serious sight-threatening conditions, including glaucoma or damage to the back of the eye (such as retinal detachment). Because of this, eye doctors are keen to find safe ways to slow down the progression of short-sightedness while children are still young.

This trial is looking at an eye drop called atropine. Eye specialists in parts of Asia have used atropine drops for many years to help slow myopia. This UK study is testing a very low strength (0.01%) to see if it is effective and safe for children in the UK. By comparing atropine drops with simple dummy drops, researchers hope to confirm whether this treatment should become widely available on the NHS.

Key takeaways

Tests whether low-dose atropine eye drops can slow down short-sightedness in children.
Open to children aged 6 to 12 years with short-sightedness in both eyes.
Involves putting one drop in each eye once a day for two years.
Includes hospital eye check-ups every six months.
Children are randomly chosen to receive either active atropine drops or plain dummy drops.

Who may be eligible?

This trial is for children aged between 6 and 12 years old who have mild to moderate short-sightedness in both eyes. Their eyesight must be able to reach a good standard when wearing their normal glasses or contact lenses.

Children cannot take part if they have very severe short-sightedness, significant astigmatism (an irregular shape of the eye), a 'lazy eye' (amblyopia), or other eye disorders. Children who have major general health conditions, allergies to the drops, or who are taking part in another clinical trial are also unable to join.

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.

My child is aged between 6 and 12 years old.
My child has short-sightedness (myopia) in both eyes.
My child can see well when wearing their glasses.
My child does not have other serious eye conditions or a lazy eye.
We can commit to using daily eye drops and attending check-ups every six months for two years.

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for two years (24 months). During this time, your child will need one drop put into each eye once every day, usually at bedtime. Two out of every three children will receive the low-dose atropine drops, while one in three will receive dummy (placebo) drops that just keep the eyes moist. A computer chooses this at random, and neither you, your child, nor the clinic staff will know which drops are being used.

You and your child will visit the eye clinic every six months for check-ups. At these visits, the team will test your child's vision, check their eye health, and ask you both to fill in brief questionnaires about general health, daily screen time, time spent playing outdoors, and how easy you find using the drops.

Potential risks and benefits

The main possible benefit is that the atropine drops might slow down how quickly your child's short-sightedness gets worse, which could lower their risk of eye complications as an adult. However, there is no guarantee of a direct benefit, especially for children who receive the dummy drops. Both types of drops are considered very safe, but possible side effects include brief stinging, slightly wider pupils (which can make bright light uncomfortable), or mild blurriness when reading up close. Rarely, children might experience red eyes or mild eyelid swelling. Joining the study is completely up to you and your child, and you can change your mind and stop at any time without your normal NHS care being affected.

Locations (8)

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

Northern Ireland Clinical Research Facility
Unverified
Belfast, Northern Ireland
Aston University
Unverified
Birmingham, England
Centre for Living
Unverified
Glasgow, Scotland
Anglia Ruskin University Eye Clinic
Unverified
Cambridge, England
Belfast Health and Social Care Trust
Unverified
Belfast, Northern Ireland
Birmingham Children’s Hospital
Unverified
Birmingham, England
Royal Hospital for Children
Unverified
Glasgow, Scotland
Cambridge University Hospitals
Unverified
Cambridge, England

Common questions

What is a placebo drop?

A placebo is a dummy treatment that looks identical to the study medicine but contains no active ingredient. In this study, it is a gentle drop designed only to keep the eye moist.

Will my child still need to wear their glasses?

Yes. The drops do not cure short-sightedness or replace spectacles. Your child will still wear their usual glasses to see clearly.

Are the drops painful to use?

Most children tolerate the drops very well, though they might cause a mild, brief sting when first put into the eye.

What happens if the drops make my child sensitive to sunlight?

Because atropine can make pupils slightly wider, some children find bright light dazzling. Wearing sunglasses or a peaked sun hat outdoors usually helps.

Can we leave the trial early if we want to?

Yes. Taking part is entirely voluntary. You can withdraw your child from the study at any point without giving a reason, and it will not affect their future care.

How to find out more

Augusto Azuara-Blanco

a.azuara-blanco@qub.ac.uk +44 (0)2890976460 Official trial record

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