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RecruitingNAINTERVENTIONAL

The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.

This research is looking at a new type of eye test called a 'photorefraction device' to see how well it can spot common vision problems, like short-sightedness, in young children. The aim is to check if this camera-based test can accurately detect these issues in children aged between 3 and 8 years old. Researchers will compare its results with traditional eye measurements, often called the 'gold standard', to make sure it's reliable. This is important because catching eye problems early in childhood can help ensure children get the right support for their vision, which can affect their learning and development.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Essilor International
Enrolment target
315
Start
01 Apr 2025
Estimated completion
01 Dec 2025

What is this study about?

This study is checking how well a special camera, called a photorefraction device, can find common eye problems in children. These problems include things like short-sightedness (myopia) or astigmatism, where the eye doesn't focus light properly. Catching these issues early is really important for children's learning and overall development.

The research wants to see if this new camera is as good as, or even better than, the usual ways doctors check children's eyesight. They will compare the results from the camera with other common eye tests. If this device works well, it could make it easier and quicker for children to get their eyes checked, leading to earlier treatment if needed.

Ultimately, this study aims to improve how we screen young children for vision problems, ensuring more children get the help they need to see clearly. It's about finding reliable and simple ways to protect children's eyesight.

Key takeaways

  • This study is testing a new camera to check children's eyesight.
  • It focuses on children aged 3 to 8 years old.
  • The goal is to find common eye problems like short-sightedness early.
  • Participation involves one visit with several eye tests, possibly including eye drops.
  • Catching vision problems early in children can greatly help their learning and development.

Who may be eligible?

To join this study, children need to be aged between 3 and 8 years old. They can wear glasses or not, and it doesn't matter what their skin type is. It's important that the child and their parent or guardian can understand what the study involves and are able to follow the instructions so that reliable measurements can be taken.

Some children won't be able to join. For example, if they are already using special treatments to control short-sightedness, like certain eye drops or contact lenses that reshape the eye. Children wearing regular contact lenses are also not eligible. If a child has any other eye or health conditions, or is taking medications that might affect their vision or the test results, they probably can't take part, unless it's for something like a squint (strabismus).

Finally, if a child has certain risks with eye drops that widen the pupil, or if they are already part of another study that might affect their vision, they won't be able to participate in this one.

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. Is your child between 3 and 8 years old?
  2. Does your child currently wear contact lenses?
  3. Is your child using special eye drops or treatments for short-sightedness?
  4. Does your child have any other serious eye conditions, apart from a squint?
  5. Can your child follow simple instructions for an eye test?
  6. Is your child covered by French medical insurance?
Answer every question to see your result.

What does participation involve?

If your child takes part, they will come for a single visit. During this visit, different eye tests will be carried out. This includes measurements with the special camera being studied, as well as a few other standard eye checks, some similar to what you might find at an optician. Some of these tests might involve using eye drops to temporarily widen their pupils, which helps the doctors get clearer readings. They will also check your child's distance vision and look for squints.

The entire visit will involve various assessments of their eyes. There are no follow-up visits or ongoing treatments involved as part of this study itself, only the single evaluation. The eye drops used are a standard part of some eye examinations.

Potential risks and benefits

Taking part might offer the benefit of a thorough eye check for your child by specialists. There's also the potential to help improve how we screen for eye problems in children in the future. Potential risks are generally low, mainly related to the temporary discomfort or blurry vision that can occur from the eye drops used to widen the pupils during the examination. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (2)

  • Dr Krafft private practice
    Verified postcode
    Nancy, France· Not yet recruiting
  • Hôpital civil de Strasbourg
    Verified postcode
    Strasbourg, France· Recruiting

Common questions

What is 'photorefraction'?

It's a way of checking eyesight using a special camera that takes pictures of the eye to see how well it focuses light.

What does 'ametropia' mean?

It's a medical term for common vision problems like short-sightedness (myopia), long-sightedness, or astigmatism, where the eye doesn't focus properly.

Will my child get any treatment in this study?

No, this study is only for testing how well a device works, not for providing treatment. Any eye problems found would be discussed with you and your GP or optician.

Are the eye drops safe for my child?

The eye drops used to widen pupils are common in eye exams for children. Researchers will check your child for any reasons they shouldn't have them.

How long will the single visit last?

The study description doesn't specify a time, but it will involve multiple eye assessments during one visit.

How to find out more

Sara Cadoni

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 "The Objective of This Study is to Evaluate the Perfomance of…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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