Red Light Childhood Myopia Proof-of-concept

University College London (UCL)

Status: Not yet enrolling

Conditions: Myopia

Treatments: Other: Red Light (PDT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06771258

EDGE 166432

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Intensity 1

Active Comparator group

Description:

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

Treatment:

Other: Red Light (PDT)

Intensity 2

Active Comparator group

Description:

Children will use red-light of low intensity, but slightly higher than in the Intensity 1 arm, twice daily for 3 minutes, at home

Treatment:

Other: Red Light (PDT)

Intensity 3

Active Comparator group

Description:

Children will use red-light of medium intensity, slightly higher than in the Intensity 2 arm, twice daily for 3 minutes, at home

Treatment:

Other: Red Light (PDT)

Intensity 4

Active Comparator group

Description:

Children will use red-light of medium intensity, slightly higher than in the Intensity 3 arm, twice daily for 3 minutes, at home

Treatment:

Other: Red Light (PDT)