MyopiaRLRLNCT07104513
Efficacy and Influencing Factors of Repeated Low-level Red-light in Myopia
An observational study of Myopia, run by Ruihua Wei at 2 sites in China.
Trial summary
To evaluate the long-term efficacy of repeated low-level red-light (RLRL) therapy in the prevention and control of myopia in children, and to analyze the key factors influencing its efficacy (such as individual differences and compliance), with the aim of providing evidence-based support for the optimization of… Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Red Light
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 2 sitesChina
- Study dates
- 28 Sep 2020to 28 Jul 2030
- Phase
- Observational
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 5-16 years old, 500
Who may be able to join
- Ages 5 to 16, gender unrestricted;
- RLRL device usage duration of one year or more.
Who cannot join
- Children with obvious strabismus and amblyopia
- With congenital eye disease, such as congenital cataract, congenital retinal disease
- Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
- Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
- Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
- Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP \>21mmHg or binocular IOP difference ≥5mmHg)
Show all 11Show fewer
- Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
- Optic nerve damage or congenital optic nerve dysfunction
- Can not be regularly checked
- The adjustment range is less than 8D or obvious near difficulties
- Other reasons researchers think it is not suitable for inclusion in researchers
Trial locations and contacts
2 sites in 1 country.
China2 sites
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 120120
Tianjin Medical University Eye Hospital
Tianjin
About this study
Official title: Study on the Long-term Efficacy Evaluation and Influencing Factors of Repeated Low-level Red-light Therapy in Myopia Prevention and Control in Children
To evaluate the long-term efficacy of repeated low-level red-light (RLRL) therapy in the prevention and control of myopia in children, and to analyze the key factors influencing its efficacy (such as individual differences and compliance), with the aim of providing evidence-based support for the optimization of clinical myopia prevention and control strategies.
Read the detailed description
This is a real world multi-centre study. The devices are connected to the internet with an automated diary function to record treatment sessions and to monitor patient compliance.The total sample size of 3000 arerandomly allocated into treatment groups,observation for 1 year and more.
- Conditions
- Myopia
- Being tested
- Red Light
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red LightDevice
use red light twice per day, both eyes. use red light for one year in The RLRL-1year Group. use red light for two year in The RLRL-2years Group. red light for three years in The RLRL-3years Group.red light for more than three years in The RLRL- more than 3years Group.
| Study group | Role | What they receive |
|---|---|---|
| The RLRL-1year Group | use red light 1 year Receives: Device: Red Light | |
| The RLRL-2years Group | Not described Receives: Device: Red Light | |
| The RLRL-3years Group | Not described Receives: Device: Red Light | |
| The RLRL-more than 3 years | use the RLRL-more than 3 years Receives: Device: Red Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
axial length
Measured: up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start28 Sep 2020
- Primary completion28 Jul 2028 (estimated)
- Study completion28 Jul 2030 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruihua Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruihua Wei, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104513
- Sponsor's protocol ID
- 2025KY-41
- Acronym
- RLRL
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Long-term Efficacy Evaluation and Influencing Factors of Repeated Low-level Red-light Therapy in Myopia Prevention and Control in Children
- ClinicalTrials.gov ID
- NCT07104513
- Acronym / sponsor ID
- RLRL / 2025KY-41
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ruihua WeiUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 28 Jul 2028 (estimated)
- Study completion
- 28 Jul 2030 (estimated)
- First posted
- 5 Aug 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.
To evaluate the long-term efficacy of repeated low-level red-light (RLRL) therapy in the prevention and control of myopia in children, and to analyze the key factors influencing its efficacy (such as individual differences and compliance), with the aim of providing evidence-based support for the optimization of clinical myopia prevention and control strategies.
Detailed description
This is a real world multi-centre study. The devices are connected to the internet with an automated diary function to record treatment sessions and to monitor patient compliance.The total sample size of 3000 arerandomly allocated into treatment groups,observation for 1 year and more.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The RLRL-1year Group | – | Device: Red Lightuse red light 1 year |
| The RLRL-2years Group | – | Device: Red Light |
| The RLRL-3years Group | – | Device: Red Light |
| The RLRL-more than 3 years | – | Device: Red Lightuse the RLRL-more than 3 years |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 5-16 years old, 500
Key inclusion criteria (2 listed)
- Ages 5 to 16, gender unrestricted;
- RLRL device usage duration of one year or more.
Key exclusion criteria (11 listed)
- Children with obvious strabismus and amblyopia
- With congenital eye disease, such as congenital cataract, congenital retinal disease
- Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
- Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
- Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
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 Lightuse red light twice per day, both eyes. use red light for one year in The RLRL-1year Group. use red light for two year in The RLRL-2years Group. red light for three years in The RLRL-3years Group.red light for more than three years in The RLRL- more than 3years Group. | Device | The RLRL-1year Group, The RLRL-2years Group, The RLRL-3years Group, The RLRL-more than 3 years |
Primary outcome
axial length
Time frame: up to 72 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 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Ruihua Wei at 2 sites 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 2 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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?
axial length (time frame: up to 72 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 8 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.