Red Light Childhood Myopia Proof-of-concept

NCT06771258 | Not Yet Recruiting

• 1 other identifier: EDGE 166432
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Spherical equivalent

  3 months

• Subfoveal choroidal thickness

  3 months

• Colour contrast sensitivity

  3 months

• Visual acuity

  3 months

• Tolerability/usability

  3 months

Study Arms (4)

Intensity 1

ACTIVE COMPARATOR

Children will use red-light of the lowest intensity, twice daily for 3 minutes, at home

Other: Red Light (PDT)

Intensity 2

ACTIVE COMPARATOR

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)

Intensity 3

ACTIVE COMPARATOR

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)

Intensity 4

ACTIVE COMPARATOR

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)

Interventions

Red Light (PDT) OTHER

Red LED light

Intensity 1; Intensity 2; Intensity 3; Intensity 4

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, London, EC1V 9EL, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Annegret Dahlmann-Noor, PhD

  UCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annegret Dahlmann-Noor, PhD

CONTACT

020 7253 3411; anngret.dahlmann@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

GB (1)