Red Light Childhood Myopia Proof-of-concept

Not Applicable

Not yet recruiting

• Conditions: Myopia

• Registration Number: NCT06771258
• Lead Sponsor: University College, London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-20
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-02-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Axial length	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 Outcome Measures

Name	Time	Method
Spherical equivalent	3 months	The team will measure the refractive error (prescription for spectacles) using an open-view autorefractor, as a secondary measure of myopia progression.
Subfoveal choroidal thickness	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.
Colour contrast sensitivity	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.
Visual acuity	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.
Tolerability/usability	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.

Trial Locations

Locations (1)

University College London; 🇬🇧 London, United Kingdom