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NCT Number: NCT06771258

Red Light Childhood Myopia Proof-of-concept

In this project the research team will begin to find out whether shining a red LED light at the eyes can slow down the worsening of short-sightedness in children.

This is important, because short-sightedness now starts at a younger age and worsens faster than in the past. Many people are at risk of permanently losing their eyesight in middle-age because of short-sightedness.

The researchers plan to use red LED light, which is safe to use. Red-light treatment improves the blood flow at the back of the eye, in a layer called "choroid", which can be measured on eye-scans. The team have done a study with healthy adults, which showed that red-light is safe and gently improves the blood flow at the back of the eye. In adults, this has no effect on myopia, because their eyes are fully grown. In children, red-light may slow down myopia, and in this project, the researchers want to find out which level of red-light is needed to have this effect. The researchers will ask 24 children age 5-12 years to use red-light for three minutes twice a day for three months. Three will be 4 groups of children, and each group will use a different level of brightness. The researchers will measure the eye length and the thickness of the choroid at the start and 1 and 3 months later and compare the change in eye length between the different groups.

In practice, children will need to use the treatment for several years. The researchers will use the results of this study to prepare a longer study with more children.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, EC1V 9EL, United Kingdom

Location contact

Annegret Dahlmann-Noor, PhD

CONTACT

[email protected]

020 7253 3411

Annegret Dahlmann-Noor, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • short-sightedness between -1.00D and -6.00 diopters in both eyes
  • best-corrected visual acuity 0.1 logMAR or better in both eyes

Exclusion criteria

  • underlying condition/syndrome causing myopia
  • previous or current myopia-modifying treatment
  • abnormal ocular refractive anatomy or previous intraocular or ocular surgery

Treatment and study plan

Red Light (PDT)

Other

Red LED light

Primary outcomes

  1. Axial length

    Time frame: 3 months

    The researchers will measure the length of the eyeballs using an optical biometer; these are the most sensitive outcome measure in myopia studies, and the least invasive measurement method.

Secondary outcomes

  1. Spherical equivalent

    Time frame: 3 months

    The team will measure the refractive error (prescription for spectacles) using an open-view autorefractor, as a secondary measure of myopia progression.

  2. Subfoveal choroidal thickness

    Time frame: 3 months

    The team will acquire an optical coherence tomography scan. On the scan, the researchers will measure the choroidal thickness, which is frequently used as a proxy measure of the treatment effect of interventions to slow myopia progression. The choroid is a vascular layer underneath the retina at the back of the eye.

  3. Colour contrast sensitivity

    Time frame: 3 months

    As a safety measure, the researchers will measure colour contrast sensitivity on a computer-screen, showing participants coloured symbols on a grey background. This is the most sensitive test for photoreceptor health, the layer of cells in the retina which change light signals to electrical signals.

  4. Visual acuity

    Time frame: 3 months

    As a secondary safety outcome, the researchers will measure the participant's visual acuity, using a test where participants read letters of reducing size on a chart.

  5. Tolerability/usability

    Time frame: 3 months

    The researchers will ask participants open-ended questions about their thoughts and experience with using red-light treatment, and about easier ways for children to use it.

Study contacts

Contact information is provided by the study sponsor or research team.

Annegret Dahlmann-Noor, PhD

CONTACT

[email protected]

020 7253 3411

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

What Effect Does Looking At Red Light Have on the Eye in Children and Young People? - a Proof-of-concept Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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