Red Light Childhood Myopia Proof-of-concept

NCT ID: NCT06771258

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-02-01

Brief Summary

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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

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Conditions

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Myopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intensity 1

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

Group Type ACTIVE_COMPARATOR

Red Light (PDT)

Intervention Type OTHER

Red LED light

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

Group Type ACTIVE_COMPARATOR

Red Light (PDT)

Intervention Type OTHER

Red LED light

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

Group Type ACTIVE_COMPARATOR

Red Light (PDT)

Intervention Type OTHER

Red LED light

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

Group Type ACTIVE_COMPARATOR

Red Light (PDT)

Intervention Type OTHER

Red LED light

Interventions

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Red Light (PDT)

Red LED light

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annegret Dahlmann-Noor, PhD

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

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University College London

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Annegret Dahlmann-Noor, PhD

Role: CONTACT

020 7253 3411

Facility Contacts

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Annegret Dahlmann-Noor, PhD

Role: primary

020 7253 3411

Annegret Dahlmann-Noor, PhD

Role: backup

Other Identifiers

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EDGE 166432

Identifier Type: -

Identifier Source: org_study_id

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