MyopiaNCT07375589
LED Low-Intensity Red Light for Myopia Control in Youth: Efficacy and Safety Study
A study testing Red light treatment with 1.6mW LED light source and Red light treatment with 0.001mW LED light source in people with Myopia and Ametropia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
The purpose of this clinical trial was to investigate the efficacy and safety of repetitive low-intensity single-wavelength red light from an LED light source in controlling myopia progression in children and adolescents. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Red light treatment with 1.6mW LED light source and Red light treatment with 0.001mW LED light source
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 8-12 years old
- Simple myopia: equivalent spherical lens ≤ -0.5D and > -6.0D after any cycloplegia, astigmatism ≤ 2.5D, anisometropia ≤ 1.5D
- The best corrected visual acuity in one eye is 0.8 and above
- Normal fundus, or only leopard-shaped fundus
- Sign informed consent and be able to participate in the study
Who cannot join
- Rule out hereditary myopia
- The subject has other congenital eye diseases, such as congenital cataract, congenital glaucoma, etc
- Presence of strabismus or other binocular vision abnormalities
- refractive media opacity: corneal opacity, cataract or intraocular lens surgery
- There are eye diseases that affect retinal function
- Children who had used or were using orthokeratology, atropine and other myopia control measures could be enrolled after stopping treatment for three months
- There are other systemic disease abnormalities
- Other reasons that the research doctor considers unsuitable for inclusion in the project
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200041
About this study
Official title: Exploratory Study on the Efficacy and Safety of LED Low-Intensity Red Light for Controlling Myopia Progression in Children and Adolescents
The purpose of this clinical trial was to investigate the efficacy and safety of repetitive low-intensity single-wavelength red light from an LED light source in controlling myopia progression in children and adolescents.
Read the detailed description
Myopia is the most prevalent ocular condition among children and adolescents worldwide. In recent years, optical interventions for myopia prevention and control have gained increasing attention, with low-intensity red light (wavelength: 650 nm) emerging as a promising therapeutic approach. Clinical studies have preliminarily demonstrated the efficacy of repeated low-level red light (RLRL) therapy in slowing myopia progression in pediatric populations. Existing research has primarily utilized semiconductor laser diodes due to their high monochromaticity and concentrated beam intensity. However, concerns persist regarding the safety of red light irradiation in clinical myopia management. The primary risks include potential damage to intraocular structures from prolonged or high-intensity exposure, coupled with the high cost of laser-based systems, which limits their widespread adoption.
In contrast to laser sources, light-emitting diodes (LEDs) operate via non-thermal mechanisms and deliver significantly lower energy output, mitigating the risk of thermal or photochemical tissue damage. Investigating the efficacy and safety of low-intensity red LED light for controlling myopia progression in children and adolescents is therefore of critical scientific and clinical importance.This study aims to evaluate the effectiveness and safety of repeated low-intensity, single-wavelength (650 nm) red LED light therapy in slowing axial elongation in children aged 8-12 years over a 3-month treatment period. Participants will receive RLRL therapy at home under parental supervision in addition to wearing single-vision spectacles, following a standardized protocol. Key outcome measures, including axial length (AL), visual acuity, cycloplegic spherical equivalent refraction (SER), intraocular pressure (IOP), slit-lamp biomicroscopy, optical coherence tomography (OCT), and optical biometry, will be assessed at baseline and at 1-week, 1-month, and 3-month follow-up intervals.
- Being tested
- Red light treatment with 1.6mW LED light source, Red light treatment with 0.001mW LED light source
- Keywords
- Myopia
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red light treatment with 1.6mW LED light sourceDevice
In addition to using a powered single vision glasses lens (SVS) to correct distance refraction, the subjects underwent two red light treatments using a 1.6mW LED light source therapy device from Monday to Friday, each treatment was 3 minutes, and the interval was 4 hours.
Red light treatment with 0.001mW LED light sourceDevice
In addition to using a powered single vision glasses lens (SVS) to correct distance refraction, subjects were treated with red light twice from Monday to Friday using a 0.001mW LED light source therapy instrument, each time for 3 minutes, with an interval of 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| LED Red light: 1.6 mW/twice daily | Experimental | Not described Receives: Device: Red light treatment with 1.6mW LED light source |
| LED Red light: 0.001 mW/twice daily | Sham comparator | Not described Receives: Device: Red light treatment with 0.001mW LED light source |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects in the intervention group received red light treatment with 1.6mW LED light source during 3 months
Subjects in the intervention group received red light treatment with 1.6mW LED light source for 3 months, and the change of axial length was compared with the increase of axial length in the blank group
Measured: 1 week，1 ,3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start16 Apr 2025
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Airdoc Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375589
- Sponsor's protocol ID
- RLED-2025
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duan Y, Qi Z, Yu F, Xiang K, Wu H, Liu Z, Feng W, Ge Z, Zou H, Xu X, He X. Effect of Photobiomodulation-Based LED on Myopia Control in Children: An Exploratory Randomized Clinical Trial. Ophthalmol Ther. 2026 Sep 7. doi: 10.1007/s40123-026-01498-8. Online ahead of print.
PubMed 42704414
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy and Safety of LED Low-Intensity Red Light for Controlling Myopia Progression in Children and Adolescents
- ClinicalTrials.gov ID
- NCT07375589
- Acronym / sponsor ID
- RLED-2025
- Keywords
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Beijing Airdoc Technology Co., Ltd.
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Jan 2026 (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.
The purpose of this clinical trial was to investigate the efficacy and safety of repetitive low-intensity single-wavelength red light from an LED light source in controlling myopia progression in children and adolescents.
Detailed description
Myopia is the most prevalent ocular condition among children and adolescents worldwide. In recent years, optical interventions for myopia prevention and control have gained increasing attention, with low-intensity red light (wavelength: 650 nm) emerging as a promising therapeutic approach. Clinical studies have preliminarily demonstrated the efficacy of repeated low-level red light (RLRL) therapy in slowing myopia progression in pediatric populations. Existing research has primarily utilized semiconductor laser diodes due to their high monochromaticity and concentrated beam intensity. However, concerns persist regarding the safety of red light irradiation in clinical myopia management. The primary risks include potential damage to intraocular structures from prolonged or high-intensity exposure, coupled with the high cost of laser-based systems, which limits their widespread adoption.
In contrast to laser sources, light-emitting diodes (LEDs) operate via non-thermal mechanisms and deliver significantly lower energy output, mitigating the risk of thermal or photochemical tissue damage. Investigating the efficacy and safety of low-intensity red LED light for controlling myopia progression in children and adolescents is therefore of critical scientific and clinical importance.This study aims to evaluate the effectiveness and safety of repeated low-intensity, single-wavelength (650 nm) red LED light therapy in slowing axial elongation in children aged 8-12 years over a 3-month treatment period. Participants will receive RLRL therapy at home under parental supervision in addition to wearing single-vision spectacles, following a standardized protocol. Key outcome measures, including axial length (AL), visual acuity, cycloplegic spherical equivalent refraction (SER), intraocular pressure (IOP), slit-lamp biomicroscopy, optical coherence tomography (OCT), and optical biometry, will be assessed at baseline and at 1-week, 1-month, and 3-month follow-up intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LED Red light: 1.6 mW/twice daily | Experimental | Device: Red light treatment with 1.6mW LED light source |
| LED Red light: 0.001 mW/twice daily | Sham comparator | Device: Red light treatment with 0.001mW LED light source |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 8-12 years old
- Simple myopia: equivalent spherical lens ≤ -0.5D and > -6.0D after any cycloplegia, astigmatism ≤ 2.5D, anisometropia ≤ 1.5D
- The best corrected visual acuity in one eye is 0.8 and above
- Normal fundus, or only leopard-shaped fundus
- Sign informed consent and be able to participate in the study
Key exclusion criteria (8 listed)
- Rule out hereditary myopia
- The subject has other congenital eye diseases, such as congenital cataract, congenital glaucoma, etc
- Presence of strabismus or other binocular vision abnormalities
- refractive media opacity: corneal opacity, cataract or intraocular lens surgery
- There are eye diseases that affect retinal function
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 treatment with 1.6mW LED light sourceIn addition to using a powered single vision glasses lens (SVS) to correct distance refraction, the subjects underwent two red light treatments using a 1.6mW LED light source therapy device from Monday to Friday, each treatment was 3 minutes, and the interval was 4 hours. | Device | LED Red light: 1.6 mW/twice daily |
| Red light treatment with 0.001mW LED light sourceIn addition to using a powered single vision glasses lens (SVS) to correct distance refraction, subjects were treated with red light twice from Monday to Friday using a 0.001mW LED light source therapy instrument, each time for 3 minutes, with an interval of 4 hours. | Device | LED Red light: 0.001 mW/twice daily |
Primary outcome
Subjects in the intervention group received red light treatment with 1.6mW LED light source during 3 months
Time frame: 1 week，1 ,3months
Subjects in the intervention group received red light treatment with 1.6mW LED light source for 3 months, and the change of axial length was compared with the increase of axial length in the blank group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 42704414Duan Y, Qi Z, Yu F, Xiang K, Wu H, Liu Z, Feng W, Ge Z, Zou H, Xu X, He X. Effect of Photobiomodulation-Based LED on Myopia Control in Children: An Exploratory Randomized Clinical Trial. Ophthalmol Ther. 2026 Sep 7. doi: 10.1007/s40123-026-01498-8. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 treatment with 1.6mW LED light source and Red light treatment with 0.001mW LED light source in people with Myopia and Ametropia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jan 2026. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects in the intervention group received red light treatment with 1.6mW LED light source during 3 months (time frame: 1 week，1 ,3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07375589, which also lists 1 linked publication.
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 29 Jan 2026.