MyopiaRMCNCT05811598
Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
A study testing repeated ultra low lever red light in people with Myopia and Amblyopia, run by Beijing Airdoc Technology Co., Ltd. at 1 site in China.
Trial summary
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- What is being tested?
- repeated ultra low lever red light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 30 Dec 2024
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3~6 years old;
- Myopia Spherical Equivalence Refraction <=-0.50D;
- Written Informed Consent;
Who cannot join
- Cannot approval with written informed consent;
- Photophobia or allergy to red light;
- With other severe conditions the principle investigators refused to enroll this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510600
Wensi Shen, MD. & Ph.D., +8613631318044, 369353779@qq.com
Daoman Xiang, MD & PhD
About this study
Official title: Random、Control and Open Study of Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported.
Read the detailed description
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported. Here we design this control and random prospective study to find the two types light with different irridance to two ages (3~4 years old and 5~6 years old) respectively. Wether the dose and effectiveness exit or not for 3~6- year- old myopia control.
- Being tested
- repeated ultra low lever red light
- Keywords
- Myopia, Children, LLLT, PBM
- Medical subject headings
- Myopia, Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated ultra low lever red lightDevice
Also called LLLT, PBM therapy
Myopia indoor lighting therapy
| Study group | Role | What they receive |
|---|---|---|
| repeated red light therapy for 3~4 year-old myopia | Experimental | 0.37mW lighting with wavelength of 650nm for the age of 3~4 years old(including both 3 and 4 years)myopia. Receives: Device: repeated ultra low lever red light |
| repeated red light therapy for 5~6 year-old myopia | Experimental | 0.60mW lighting with wavelength of 650nm for the age of 5~6 years old(including both 5 and 6 years)myopia. Receives: Device: repeated ultra low lever red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean changes of axial length vaules by millimeter at follow-up from baseline.
Ocular axial length measured by IOLmaster500 or Lenstar will be measured and recorded at follow-ups and at baseline. The changes values of axial length of both groups will be compared as the main outcome to compare the effectiveness of repeated red light thearpy.
Measured: at 3-month and at 6-month
Secondary outcomes (2)
Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D)
Cycloplegic refraction changes from baseline will be measured and recorded at follow-up and at baseline. Spherical equivalence will be calculated with the formular of SE=spherical diopter+1/2cylinder diopter
Measured: at 3-month and at 6-month
Number of Participants with unsafety issues during the study
Adverse event and device failure rate
Measured: at 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start21 Mar 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Dec 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups for the 2 lighting lever (0.37mW and 0.6mW）for 2 groups of ages (3\~4 years old and 5\~6 years old)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chao He, PhD, Study director, Beijing Airdoc Technology Co., Ltd.Daoman Xiang, MD, PhD, Principal investigator, Guangzhou Women and Children's Medical CenterWensi Shen, MD, PhD, Study chair, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811598
- Sponsor's protocol ID
- Beijing Airdoc Technology Co.,
- Acronym
- RMC
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 25 Apr 2023
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random、Control and Open Study of Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
- ClinicalTrials.gov ID
- NCT05811598
- Acronym / sponsor ID
- RMC / Beijing Airdoc Technology Co.,
- Keywords
- Myopia, Children, LLLT, PBM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Apr 2023 (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.
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported.
Detailed description
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported. Here we design this control and random prospective study to find the two types light with different irridance to two ages (3~4 years old and 5~6 years old) respectively. Wether the dose and effectiveness exit or not for 3~6- year- old myopia control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups for the 2 lighting lever (0.37mW and 0.6mW）for 2 groups of ages (3~4 years old and 5~6 years old)
| Arm | Type | Receives |
|---|---|---|
| repeated red light therapy for 3~4 year-old myopia | Experimental | Device: repeated ultra low lever red light0.37mW lighting with wavelength of 650nm for the age of 3~4 years old(including both 3 and 4 years)myopia. |
| repeated red light therapy for 5~6 year-old myopia | Experimental | Device: repeated ultra low lever red light0.60mW lighting with wavelength of 650nm for the age of 5~6 years old(including both 5 and 6 years)myopia. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 3~6 years old;
- Myopia Spherical Equivalence Refraction <=-0.50D;
- Written Informed Consent;
Key exclusion criteria (3 listed)
- Cannot approval with written informed consent;
- Photophobia or allergy to red light;
- With other severe conditions the principle investigators refused to enroll this study
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 |
|---|---|---|
| repeated ultra low lever red lightAlso: LLLT, PBM therapyMyopia indoor lighting therapy | Device | repeated red light therapy for 3~4 year-old myopia, repeated red light therapy for 5~6 year-old myopia |
Primary outcome
Mean changes of axial length vaules by millimeter at follow-up from baseline.
Time frame: at 3-month and at 6-month
Ocular axial length measured by IOLmaster500 or Lenstar will be measured and recorded at follow-ups and at baseline. The changes values of axial length of both groups will be compared as the main outcome to compare the effectiveness of repeated red light thearpy.
2 secondary outcomes
Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D)
Time frame: at 3-month and at 6-month
Number of Participants with unsafety issues during the study
Time frame: at 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- 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. This study is not recruiting at the moment.
Chao He, PhD study director
Beijing Airdoc Technology Co., Ltd.
Daoman Xiang, MD, PhD principal investigator
Guangzhou Women and Children's Medical Center
Wensi Shen, MD, PhD study chair
Guangzhou Women and Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeated ultra low lever red light in people with Myopia and Amblyopia, run by Beijing Airdoc Technology Co., Ltd. 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 3 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wensi Shen, MD,PhD (+8613631318044, 369353779@QQ.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes of axial length vaules by millimeter at follow-up from baseline. (time frame: at 3-month and at 6-month). 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 25 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.