MyopiaNCT04825769
Red Light Intervention for Myopia Prevention
A study testing LLLT（Low Level Laser Therapy） in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Myopia
- What is being tested?
- LLLT（Low Level Laser Therapy）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2021to 31 Aug 2022
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Students of grade 1-4 in the participating schools;
- Students' eyes have no myopia, that is the cycloplegic spherical equivalent（SE） >-0.50D, and at least one eye accords with the pre-myopic state, that is -0.50D <cycloplegic SE≤0.50D;
- Students whose mother and/or father are in myopia status (SE < -3.0D for either of eyes);
- Students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys.
Who cannot join
- Students whose parents do not sign informed consent;
- Students who have strabismus and/or other binocular vision abnormality;
- Students who have other eye diseases and/or systematic diseases;
- Students who have DC <=-1.5D;
- Students whose difference of SE between the two eyes >=1.5D;
- Students who meet the standards with which investigators and study physicians think it is not appropriate to enroll.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.
To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.
- Conditions
- Myopia
- Being tested
- LLLT（Low Level Laser Therapy）
- Keywords
- Children and adolescents, Myopia, Prevention and control, 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.
LLLT（Low Level Laser Therapy）Device
2 times a day, 3 minutes each time, with an interval of more than 4 hours. During the semester: From Monday to Friday, set up an intervention room in the school; For winter and summer vacation: everyday at home
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Red light irradiation was conducted at school from Monday to Friday and at home everyday in summer and winter holiday twice a day for 3 minutes per time, with an interval of 4 hours Receives: Device: LLLT（Low Level Laser Therapy） |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year cumulative incidence of myopia (%) in the intervention group and the control group.
Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D
Measured: 1 year
Secondary outcomes (4)
The progress of spherical equivalent(SE,D) of children in intervention group and control group.
The spherical equivalent(SE,D) will be measured by autorefractor(KR-8900, Topcon).
Measured: 1 year
The progress of axial length of children in intervention group and control group.
The axial length will be measured using IOLMaster.
Measured: 1 year
The progress of choroidal thickness in children in pre-myopia state in intervention group and control group.
The choroidal thickness will be measured using SS-OCT.
Measured: 1 year
The change of uncorrected visual acuity (UCVA) of children in intervention group and control group.
The uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start25 Mar 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangui He, Study director, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825769
- Sponsor's protocol ID
- SHYB2021001
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He X, Wang J, Zhu Z, Xiang K, Zhang X, Zhang B, Chen J, Yang J, Du L, Niu C, Leng M, Huang J, Liu K, Zou H, He M, Xu X. Effect of Repeated Low-level Red Light on Myopia Prevention Among Children in China With Premyopia: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e239612. doi: 10.1001/jamanetworkopen.2023.9612.
PubMed 37099298
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.
- ClinicalTrials.gov ID
- NCT04825769
- Acronym / sponsor ID
- SHYB2021001
- Conditions
- Myopia
- Keywords
- Children and adolescents, Myopia, Prevention and control, Red light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 1 Apr 2021 (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 explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: LLLT（Low Level Laser Therapy）Red light irradiation was conducted at school from Monday to Friday and at home everyday in summer and winter holiday twice a day for 3 minutes per time, with an interval of 4 hours |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Students of grade 1-4 in the participating schools;
- Students' eyes have no myopia, that is the cycloplegic spherical equivalent（SE） >-0.50D, and at least one eye accords with the pre-myopic state, that is -0.50D <cycloplegic SE≤0.50D;
- Students whose mother and/or father are in myopia status (SE < -3.0D for either of eyes);
- Students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys.
Key exclusion criteria (6 listed)
- Students whose parents do not sign informed consent;
- Students who have strabismus and/or other binocular vision abnormality;
- Students who have other eye diseases and/or systematic diseases;
- Students who have DC <=-1.5D;
- Students whose difference of SE between the two eyes >=1.5D;
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 |
|---|---|---|
| LLLT（Low Level Laser Therapy）2 times a day, 3 minutes each time, with an interval of more than 4 hours. During the semester: From Monday to Friday, set up an intervention room in the school; For winter and summer vacation: everyday at home | Device | Intervention |
Primary outcome
One-year cumulative incidence of myopia (%) in the intervention group and the control group.
Time frame: 1 year
Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D
4 secondary outcomes
The progress of spherical equivalent(SE,D) of children in intervention group and control group.
Time frame: 1 year
The progress of axial length of children in intervention group and control group.
Time frame: 1 year
The progress of choroidal thickness in children in pre-myopia state in intervention group and control group.
Time frame: 1 year
The change of uncorrected visual acuity (UCVA) of children in intervention group and control group.
Time frame: 1 year
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 30 Sep 2022.
- Derived from this study: PubMed 37099298He X, Wang J, Zhu Z, Xiang K, Zhang X, Zhang B, Chen J, Yang J, Du L, Niu C, Leng M, Huang J, Liu K, Zou H, He M, Xu X. Effect of Repeated Low-level Red Light on Myopia Prevention Among Children in China With Premyopia: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e239612. doi: 10.1001/jamanetworkopen.2023.9612.
- 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.
Xiangui He study director
Shanghai Eye Disease Prevention and Treatment 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 LLLT（Low Level Laser Therapy） in people with Myopia, 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 4 inclusion and 6 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 30 Sep 2022. 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?
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?
One-year cumulative incidence of myopia (%) in the intervention group and the control group. (time frame: 1 year). 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 NCT04825769, 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 30 Sep 2022.