MyopiaNCT05832723
A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents
An observational study of Myopia, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- 650 nm low-level red-light
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2023to 28 Mar 2026
- Phase
- Observational
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children aged 7-18 years, and is willing to use 650 nm low-level red-light to control or prevent myopia.
Who may be able to join
- Children aged 7 to 18 years
- The cycloplegic spherical equivalent error (SER) is +0.5D or less in both eyes
- Astigmatism of 2.5 D or less (≤2.5D)
- Willing to participate in the study and sign the informed consent form
Who cannot join
- Including but not limited to the following eye diseases: strabismus, amblyopia, ocular tumors, glaucoma/macular disease and other fundus diseases (including heredity), keratitis, eye trauma, uveitis
- Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases
- Mental diseases
- Similar interventions have been used in the past year
- Allergic to cycloplegic agents or to red light
- The 650nm red light intervention was not suitable for the condition evaluated by the researchers
- are currently using atropine or similar drugs, or have stopped using them for less than 1 month
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Red light
Beijing, Beijing Municipality, 100005
Kai Cao, 01058265900, anzhen602@163.com
About this study
Official title: A Real-world Study to Evaluate the Efficacy of 650nm Low-intensity Single-wavelength Red Light in the Prevention and Control of Myopia in Children and Adolescents
To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Participants included children(aged 7 to 18 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.
Read the detailed description
This multicenter real world study will be conducted in at least 100 hospitals: Beijing Tongren Hospital will be the initiator of the study, other hospitals such as the Capital Institute of Pediatrics will serve as sub-centers. The whole study will last for three years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, and two-year follow-up. Participants who used 650 nm low-level red-light would be recruited. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.
- Conditions
- Myopia
- Being tested
- 650 nm low-level 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.
650 nm low-level red-lightDevice
Typically, children who uses the 650 nm low-level red-light will be recruited into this study. The use of any other myopia intervention is not restricted except for low concentrations of atropine. Because atropine will cause pupils dilated, the amount of light entering the eye can not be controlled, and red-light is a laser, to be safe, we need to take certain consideration of the amount of light-entering. Participants receive the 650 nm low-level red-light intervention not because they are enrolled in a study, they would receive the intervention in the same manner and intensity if they were not enrolled in the study.
| Study group | Role | What they receive |
|---|---|---|
| 650 nm low-level red-light | Children who are exposed to the 650 nm low-level red-light will be recruited into the cohort, the exposure factor is red-light irradiation. The study does not give interventions, but only recruit children who received or who is receiving the 650 nm low-level red-light intervention for observation. Receives: Device: 650 nm low-level red-light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in axial length
Use an optical biometer to measure the axial length
Measured: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in spherical equivalent error
Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too.
Measured: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Secondary outcomes (6)
Change in Choroid thickness to measure
Use an enhanced-depth imaging technique (based on Optical coherence tomography )
Measured: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in steep keratometry
Use an optical biometer to measure
Measured: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in flat keratometry
Use an optical biometer to measure
Measured: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in length thickness
Use an optical biometer to measure
Measured: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in anterior chamber depth
Use an optical biometer to measure
Measured: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in central corneal thickness
Use an optical biometer to measure
Measured: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start15 Apr 2023
- Primary completion28 Mar 2026 (estimated)
- Study completion28 Mar 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 Beijing Tongren HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jie, MD, Beijing Tongren Hospital
- Investigators
- Ying Jie, PhD, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832723
- Sponsor's protocol ID
- TongrenJY2023
- Status last verified
- Oct 2024
- First submitted
- 19 Mar 2023
- Last updated
- 8 Oct 2024
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study to Evaluate the Efficacy of 650nm Low-intensity Single-wavelength Red Light in the Prevention and Control of Myopia in Children and Adolescents
- ClinicalTrials.gov ID
- NCT05832723
- Acronym / sponsor ID
- TongrenJY2023
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 27 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.
To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Participants included children(aged 7 to 18 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.
Detailed description
This multicenter real world study will be conducted in at least 100 hospitals: Beijing Tongren Hospital will be the initiator of the study, other hospitals such as the Capital Institute of Pediatrics will serve as sub-centers. The whole study will last for three years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, and two-year follow-up. Participants who used 650 nm low-level red-light would be recruited. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 650 nm low-level red-light | – | Device: 650 nm low-level red-lightChildren who are exposed to the 650 nm low-level red-light will be recruited into the cohort, the exposure factor is red-light irradiation. The study does not give interventions, but only recruit children who received or who is receiving the 650 nm low-level red-light intervention for observation. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children aged 7-18 years, and is willing to use 650 nm low-level red-light to control or prevent myopia.
Key inclusion criteria (4 listed)
- Children aged 7 to 18 years
- The cycloplegic spherical equivalent error (SER) is +0.5D or less in both eyes
- Astigmatism of 2.5 D or less (≤2.5D)
- Willing to participate in the study and sign the informed consent form
Key exclusion criteria (7 listed)
- Including but not limited to the following eye diseases: strabismus, amblyopia, ocular tumors, glaucoma/macular disease and other fundus diseases (including heredity), keratitis, eye trauma, uveitis
- Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases
- Mental diseases
- Similar interventions have been used in the past year
- Allergic to cycloplegic agents or to red light
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 |
|---|---|---|
| 650 nm low-level red-lightTypically, children who uses the 650 nm low-level red-light will be recruited into this study. The use of any other myopia intervention is not restricted except for low concentrations of atropine. Because atropine will cause pupils dilated, the amount of light entering the eye can not be controlled, and red-light is a laser, to be safe, we need to take certain consideration of the amount of light-entering. Participants receive the 650 nm low-level red-light intervention not because they are enrolled in a study, they would receive the intervention in the same manner and intensity if they were not enrolled in the study. | Device | 650 nm low-level red-light |
Primary outcome
Change in axial length
Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Use an optical biometer to measure the axial length
Change in spherical equivalent error
Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too.
6 secondary outcomes
Change in Choroid thickness to measure
Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in steep keratometry
Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in flat keratometry
Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in length thickness
Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in anterior chamber depth
Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Change in central corneal thickness
Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- 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.
Ying Jie, PhD principal investigator
Beijing Tongren Hospital
1 site 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 Beijing Tongren Hospital 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 7 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 8 Oct 2024. 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 Kai Cao (01058265900, caozhi@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in axial length (time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up). The study lists 2 primary outcomes in all. 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 Oct 2024.