Red Light Childhood Myopia Proof-of-concept

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Other: Red Light (PDT)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annegret Dahlmann-Noor, PhD; Phone Number: 020 7253 3411; Email: anngret.dahlmann@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 9EL
    • University College London
    • Contact: Annegret Dahlmann-Noor, PhD; Phone Number: 020 7253 3411; Email: anngret.dahlmann@ucl.ac.uk
    • Contact: Annegret Dahlmann-Noor, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intensity 1; Children will use red-light of the lowest intensity, twice daily for 3 minutes, at home	Other: Red Light (PDT); Red LED light
Active Comparator: Intensity 2; Children will use red-light of low intensity, but slightly higher than in the Intensity 1 arm, twice daily for 3 minutes, at home	Other: Red Light (PDT); Red LED light
Active Comparator: Intensity 3; Children will use red-light of medium intensity, slightly higher than in the Intensity 2 arm, twice daily for 3 minutes, at home	Other: Red Light (PDT); Red LED light
Active Comparator: Intensity 4; Children will use red-light of medium intensity, slightly higher than in the Intensity 3 arm, twice daily for 3 minutes, at home	Other: Red Light (PDT); Red LED light

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	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.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Annegret Dahlmann-Noor, PhD, UCL

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EDGE 166432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No