Patient Research
Sign in
All studies
RecruitingTherapeutic use (Phase IV)Interventional

Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population

Short-sightedness, or myopia, is common in children and can get worse as their eyes grow. If a child's eyes grow too quickly, it can cause higher prescriptions and raise the risk of eye problems later in life. This clinical study is testing two treatments designed to slow down this growth: eye drops containing a medicine called atropine, and specialised spectacle lenses known as DIMS (Defocus Incorporated Multiple Segments) lenses. Both treatments are already available, but this study directly compares them to see how safe they are and how well they work in children. Doctors will check how your child's prescription changes over time. They will also take careful measurements of the eye's shape, length, and internal pressure using gentle, standard eye tests to ensure their eyes stay healthy.

At a glance

Status
Recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Hospital Clinico San Carlos
Enrolment target
111
Start
18 Jul 2024
Myopia

What is this study about?

Short-sightedness, known medically as myopia, means nearby objects look clear, but things in the distance appear blurry. In children, short-sightedness often gets worse because the eyeball grows slightly too long from front to back. While standard glasses help children see clearly day-to-day, they do not stop the eye from continuing to grow longer. Over time, high levels of short-sightedness can increase the chance of developing other eye conditions in adulthood.

To help protect children's long-term vision, eye specialists have developed treatments aimed at slowing down this eye growth. Two common options are low-dose atropine eye drops and specialised glasses known as DIMS lenses. DIMS lenses look like normal glasses, but they have a clever microscopic pattern around the edges that sends signals to the eye to slow down its growth. Atropine drops work differently, using a mild medication applied at bedtime to achieve a similar slowing effect.

This study is a Phase IV trial, which means both treatments have already been approved and used in everyday practice. Researchers now want to carefully compare them in a large group of children to see which approach works best, how comfortable they are to use, and whether combining or comparing them reveals any mild side effects. By measuring how the eye changes over time, the findings will help eye doctors choose the best options for young people with myopia in the future.

Key takeaways

  • The study compares two proven treatments: atropine eye drops and special DIMS spectacle lenses.
  • The main aim is to slow down how quickly short-sightedness worsens in children.
  • Children will have detailed, gentle eye check-ups to track eye shape and prescription changes.
  • Both treatments are already used in medical practice and have good safety records.
  • Taking part is completely voluntary and you can leave at any time.

Who may be eligible?

This study is designed for children and young people who have short-sightedness (myopia). Both boys and girls can take part. Because the goal is to slow down eye growth while the eyes are still developing, participants must be at an age where their vision is still changing.

To join, your child must have a confirmed prescription for short-sightedness and be able to wear glasses or use daily eye drops as directed. They should also be comfortable sitting for routine eye tests at the clinic.

Children may not be able to take part if they have other major eye conditions, previous eye surgery, or known allergies to the eye drops used during testing. Your eye specialist will review your child's medical history to check if the study is suitable for them.

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.

  1. My child is a child or teenager with short-sightedness (myopia).
  2. My child's glasses prescription has been changing as they grow.
  3. My child is able to wear glasses daily or use nightly eye drops.
  4. My child does not have other serious eye conditions or eye diseases.
  5. We are able to attend regular eye clinic appointments for check-ups and scans.
Answer every question to see your result.

What does participation involve?

Taking part in this study involves regular visits to an eye clinic. Your child will be assigned to a treatment group to receive either the atropine eye drops, the special DIMS spectacle lenses, or standard care.

During clinic visits, eye specialists will carry out routine vision tests. They will place gentle drops into your child's eyes to relax the focusing muscles (cycloplegia) so they can measure the exact prescription accurately. The clinic team will also take detailed photos and painless scans of the back of the eye (retina and choroid), measure the length of the eyeball, and check eye pressure.

Visits usually take place every few months over a period of one to two years. The study team will check in regularly to see how your child is getting on with their drops or glasses and ensure their eyes remain healthy.

Potential risks and benefits

Your child may benefit from close, regular monitoring by eye specialists and might experience a slower progression of their short-sightedness, which protects their long-term vision. However, there is no guarantee the treatments will stop their prescription from changing. Possible risks include mild side effects from the atropine eye drops, such as temporary light sensitivity, blurred close-up vision, or brief stinging when the drops are put in. The testing drops used at appointments can also make pupils larger and vision blurry for a few hours. Taking part is completely voluntary, and you can withdraw your child from the study at any time without it affecting their normal NHS care.

Locations (1)

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

Common questions

What are DIMS lenses?

DIMS stands for Defocus Incorporated Multiple Segments. They are special spectacle lenses that look like ordinary glasses but have tiny treatment zones to help slow down eye growth.

Will the eye drops hurt my child?

Atropine drops may sting slightly for a few seconds when put in. Some children also notice mild sensitivity to bright light or slightly blurry reading vision, which usually wears off.

Will my child still need to wear glasses?

Yes. Children in the study will still need clear vision for school and daily life, either through the special DIMS glasses or standard corrective lenses alongside the eye drops.

Are the eye scans painful?

No. The scans and measurements (such as OCT scans and eyeball length checks) are completely painless, quick, and do not touch the eye directly.

Can we stop taking part if our child does not like it?

Yes. You can leave the study at any point. Your decision will not change the standard eye care or support your child receives from the clinic.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "Postmarketing Parallel Randomized Clinical Trial to Determin…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.