MyopiaNCT06771258
Red Light Childhood Myopia Proof-of-concept
A study testing Red Light (PDT) in people with Myopia, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Red Light (PDT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- short-sightedness between -1.00D and -6.00 diopters in both eyes
- best-corrected visual acuity 0.1 logMAR or better in both eyes
Who cannot join
- underlying condition/syndrome causing myopia
- previous or current myopia-modifying treatment
- abnormal ocular refractive anatomy or previous intraocular or ocular surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University College London
London, London, EC1V 9EL
Annegret Dahlmann-Noor, PhD, 020 7253 3411, anngret.dahlmann@ucl.ac.uk
Annegret Dahlmann-Noor, PhD
About this study
Official title: 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.
Read more
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
- Being tested
- Red Light (PDT)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Light (PDT)Other
Red LED light
| Study group | Role | What they receive |
|---|---|---|
| Intensity 1 | Active comparator | Children will use red-light of the lowest intensity, twice daily for 3 minutes, at home Receives: 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 Receives: 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 Receives: 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 Receives: Other: Red Light (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Spherical equivalent
The team will measure the refractive error (prescription for spectacles) using an open-view autorefractor, as a secondary measure of myopia progression.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Dahlmann-Noor, PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771258
- Sponsor's protocol ID
- EDGE 166432
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Effect Does Looking At Red Light Have on the Eye in Children and Young People? - a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT06771258
- Acronym / sponsor ID
- EDGE 166432
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intensity 1 | Active comparator | Other: Red Light (PDT)Children will use red-light of the lowest intensity, twice daily for 3 minutes, at home |
| Intensity 2 | Active comparator | Other: Red Light (PDT)Children will use red-light of low intensity, but slightly higher than in the Intensity 1 arm, twice daily for 3 minutes, at home |
| Intensity 3 | Active comparator | Other: Red Light (PDT)Children will use red-light of medium intensity, slightly higher than in the Intensity 2 arm, twice daily for 3 minutes, at home |
| Intensity 4 | Active comparator | Other: Red Light (PDT)Children will use red-light of medium intensity, slightly higher than in the Intensity 3 arm, twice daily for 3 minutes, at home |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- short-sightedness between -1.00D and -6.00 diopters in both eyes
- best-corrected visual acuity 0.1 logMAR or better in both eyes
Key exclusion criteria (3 listed)
- underlying condition/syndrome causing myopia
- previous or current myopia-modifying treatment
- abnormal ocular refractive anatomy or previous intraocular or ocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Light (PDT)Red LED light | Other | Intensity 1, Intensity 2, Intensity 3, Intensity 4 |
Primary outcome
Axial length
Time frame: 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.
5 secondary outcomes
Spherical equivalent
Time frame: 3 months
Subfoveal choroidal thickness
Time frame: 3 months
Colour contrast sensitivity
Time frame: 3 months
Visual acuity
Time frame: 3 months
Tolerability/usability
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annegret Dahlmann-Noor, PhD principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Light (PDT) in people with Myopia, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annegret Dahlmann-Noor, PhD (020 7253 3411, anngret.dahlmann@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.