Not yet recruitingOBSERVATIONAL

Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population

This study, called PRIME, is exploring new ways to help children with short-sightedness (myopia). It focuses on children aged 6 to 12 in Europe whose short-sightedness is getting worse. Researchers want to see if special new spectacle lenses, called 'open ring' designs, can slow down this progression more effectively than a standard short-sightedness control lens already on the market. 180 children will be randomly assigned to wear one of three types of glasses: the standard control lens or one of the two new 'open ring' designs. They will wear these glasses all day for 12 months, and then some groups will continue for another 12 months. The goal is to find better ways to manage short-sightedness in children and protect their long-term eye health.

At a glance

Status

Not yet recruiting

Sponsor

Indizen Optical Technologies, S.L.U.

Enrolment target

180

Start

01 Apr 2026

Estimated completion

01 Oct 2028

Myopia Progression

What is this study about?

Many children today develop short-sightedness, also known as myopia, which means distant objects look blurry. For some children, short-sightedness can get worse quite quickly. This study, called PRIME, is looking for ways to slow down this worsening in children aged 6 to 12.

The researchers are particularly interested in new types of glasses lenses that are designed to control short-sightedness. They want to compare two new lens designs, called `Open Ring 1` and `Open Ring 2`, with a lens that's already used to help manage short-sightedness. The aim is to see if these new designs are better at stopping short-sightedness from getting worse.

Over two years, 180 children from different parts of Europe will take part. They will be carefully monitored to see how their short-sightedness changes while wearing the different types of glasses. Finding effective ways to control short-sightedness in childhood is important because severe short-sightedness can sometimes lead to other eye problems later in life.

Key takeaways

The study tests new glasses designs to slow down worsening short-sightedness in children.
It involves children aged 6 to 12 with short-sightedness.
Children will wear specific study glasses for 12 to 24 months.
Regular eye checks are part of participating.
Participation is free, and parents can withdraw their child anytime.

Who may be eligible?

This study is looking for children aged 6 to 12 years old who have short-sightedness. Your child's short-sightedness needs to be within certain limits: not too mild and not too severe. They should also generally have healthy eyes and be able to see quite well with glasses.

To join, your child must be able to wear the study glasses all day long and attend all appointments. We need parents or guardians to fully understand the study and give permission. We're looking for an equal number of boys and girls, and an equal number of younger children (6-9 years old) and older children (10-12 years old).

Children can't join if they have certain eye conditions (like a squint, lazy eye, or a history of eye surgery), severe allergies to eye drops, or other serious health problems that might affect their eyes or their ability to wear glasses. Also, if your child is already in another medical study or has had special treatments for short-sightedness before, they won'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 my child between 6 and 12 years old?
Does my child have short-sightedness (myopia)?
Does my child generally have healthy eyes?
Can my child's current vision be corrected well with glasses?
Is my child able and willing to wear glasses all day?
Has my child NOT had any previous treatments for managing short-sightedness (like special contacts or eye drops)?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will be randomly assigned to wear one of three different types of study glasses. It's important that they wear these glasses for all their waking hours every day for 12 months. They will have regular eye check-ups at the clinic during this time.

After the first 12 months, some children will continue wearing their assigned glasses for another 12 months. For one group, if their short-sightedness is still progressing, they might switch to a slightly different version of their assigned lens. All visits and eye tests will be free, and the study will last a total of 12 or 24 months, depending on which group your child is in.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if one of the new lens designs proves more effective at slowing down your child's short-sightedness than their current glasses or the control lens. This could help protect their eye health in the long run. As with any study, there's always a chance the new lenses may not work better than standard treatments, or your child might experience mild discomfort from wearing new glasses, though this is usually temporary. You are free to withdraw your child from the study at any time, for any reason, without it affecting their regular medical care.

Locations (3)

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

Universidade Do Minho
Verified postcode
Braga, Portugal
Hospital Universitario Clínico San Carlos
Verified postcode
Madrid, Spain
Ulster University
Verified postcode
Coleraine, United Kingdom

Common questions

What is myopia?

Myopia is the medical term for short-sightedness, where distant objects look blurry.

Will my child know if they are getting the new lens or the standard one?

No, this is a 'double-masked' study, meaning neither you nor the doctors will know which specific lens your child is wearing until the study is over.

How long will my child need to wear the study glasses?

Your child will need to wear the study glasses for all waking hours for at least 12 months, and potentially for 24 months, depending on their group.

What if my child's eyesight gets worse during the study?

Your child will have regular eye checks to monitor their vision and ensure their safety and well-being throughout the study.

Will I have to pay for the study glasses or appointments?

No, all consultations, eye tests, and the special glasses provided for the study are free of charge.

How to find out more

Eva Chamorro Guitierrez

evachamorro@iot.es +34(91) 8333786 Official trial record

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