RecruitingNAINTERVENTIONAL

Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years

This research is testing a new type of glasses lens, called MCL1, designed to help slow down how quickly a child's short-sightedness (myopia) gets worse. It will involve children aged between 6 and 14 years old. The main aim is to see if this new lens is better at slowing the eye's growth compared to an existing myopia control lens, MCL2, which also offers good vision. Children in the study will wear both types of lenses, one in each eye, switching them over after six months. They'll have regular hospital visits for eye tests and will complete short weekly surveys about wearing their glasses and their daily activities. Myopia is a common condition that can worsen over time, and this study hopes to find improved ways to manage it in children.

At a glance

Status

Recruiting

Phase

Sponsor

Essilor International

Enrolment target

Start

18 Mar 2026

Estimated completion

01 May 2028

Myopia Progression

What is this study about?

Many children today are becoming short-sighted, meaning distant objects look blurry. This condition, called myopia, often gets worse over time, particularly while children are growing. If myopia becomes very severe, it can sometimes lead to more serious eye problems later in life. That's why scientists and doctors are always looking for ways to stop or slow down this progression in children.

This study is testing a new type of glasses lens, called MCL1, which has been designed to better control the progression of short-sightedness. You might think of it as an improved version of glasses that do more than just correct vision – they actively try to slow down how much the eye changes. The researchers want to compare this new lens to another type of glasses lens, MCL2, which is already used to help slow myopia down and is known for providing good vision quality.

By comparing MCL1 and MCL2, the doctors hope to understand if the newer lens is more effective at slowing the rate at which a child's short-sightedness gets worse. They will be particularly interested in how children of different ages, especially younger ones, respond to the new lenses. The information gathered from this study could help eye doctors choose the best glasses for children with myopia in the future.

Key takeaways

Tests new glasses lenses (MCL1) designed to slow down short-sightedness in children.
Compares MCL1 to an existing 'myopia control' lens (MCL2) over 12 months.
Suitable for children aged 6-14 with specific levels of short-sightedness.
Involves wearing different lenses in each eye and switching after 6 months.
Requires two hospital visits and weekly online questionnaires.
Aims to find better ways to manage worsening short-sightedness in children.

Who may be eligible?

This study is looking for children aged 6 to 14 years old who are short-sighted. To take part, your child's short-sightedness needs to be within a specific range, not too mild and not too severe, and any difference in vision between their two eyes should not be too big. They must also have good clear vision when wearing their regular glasses or contact lenses.

It's important that your child hasn't used any other treatments to slow down their myopia before, like special contact lenses, eye drops, or other types of 'braking' glasses, as this could affect the results. Children with certain eye conditions, like a 'lazy eye' (amblyopia), misaligned eyes (strabismus), or other known eye diseases, cannot be part of this study. Also, if your child has other medical conditions or takes certain medications that might affect their eyes, or has had eye surgery, they wouldn't be able to join.

Finally, for your child to join, both parents (or the main caregiver if there's only one) would need to give their permission, and your child should also be happy and willing to wear the study glasses and cooperate with the eye tests.

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 14 years old?
Does your child have short-sightedness, but not very mild or very severe?
Has your child *never* used special lenses or drops to control their short-sightedness before?
Does your child not have other major eye conditions like a 'lazy eye' or misaligned eyes?
Are both parents (or the main caregiver) and your child happy to take part and follow instructions?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will wear two different types of lenses: the new lens (MCL1) in one eye and the comparison lens (MCL2) in the other. They will wear these for six months. After six months, the lenses will be swapped, so the MCL1 lens goes into the other eye and the MCL2 lens goes into the first eye, for another six months. This means your child will wear the study glasses for a total of 12 months.

During this year, your child will need to visit the hospital twice: once after 6 months and again at the end of the study after 12 months. These visits will involve eye tests to check their vision and how their eyes are changing. In between these visits, you'll be asked to help your child fill out very short questionnaires online every week. These will ask about how often they wear their glasses, how clear their vision is with them, and what activities they do outside of school.

Potential risks and benefits

Taking part in this study might offer your child the potential benefit of slowing down the progression of their short-sightedness more effectively than regular glasses. However, there's no guarantee that the new lenses will work or be better for your child than existing options. Possible risks are minimal, mainly involving the inconvenience of wearing different lenses in each eye, potential slight differences in vision quality between the two lenses, and the time commitment for hospital visits and weekly questionnaires. You are free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild
Verified postcode
Paris, France· Recruiting

Common questions

What is myopia?

Myopia is the medical term for short-sightedness, where distant objects look blurry. It's a common eye condition, especially in children.

What are 'myopia control lenses'?

These are special glasses lenses designed not just to correct vision but also to help slow down how quickly a child's short-sightedness gets worse over time.

Will my child have to wear contact lenses?

No, this study is only about glasses lenses (MCL1 and MCL2), not contact lenses. Children will wear regular glasses frames.

Will my child know which lens is which?

Neither your child nor the researchers will know which specific lens (MCL1 or MCL2) is in which eye at any given time. This helps keep the study fair and unbiased.

How long does the study last?

Your child will take part in the study for a total of 12 months. This includes two main hospital visits.

How to find out more

Thibaut Chapron, MD

tchapron@for.paris 00331 48 03 65 56 Official trial record

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