Using low-intensity red light to control myopia in children and adolescents
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
This study is testing whether wearing a special device that uses low-intensity red light can help prevent worsening myopia in children and teens aged 7 to 18.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05832723 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of 650nm low-level red-light irradiation for controlling and preventing myopia in children aged 7 to 18 years. Conducted across at least 100 hospitals, including Beijing Tongren Hospital as the lead site, the study will follow participants for three years with data analysis at 6 months, 1 year, and 2 years. Participants will use a headworn device that delivers the red light treatment, which has been verified for safety by regulatory authorities in China.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 18 years with myopia or low hyperopia and a spherical equivalent error of 0.5D or below.
Not a fit: Patients with significant eye diseases, systemic diseases, or those who have used similar interventions in the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to slow the progression of myopia in children and adolescents.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children aged 7 to 18 years 2. The cycloplegic spherical equivalent error (SER) is +0.5D or less in both eyes 3. Astigmatism of 2.5 D or less (≤2.5D) 4. Willing to participate in the study and sign the informed consent form Exclusion Criteria: 1. 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 2. Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases 3. Mental diseases 4. Similar interventions have been used in the past year 5. Allergic to cycloplegic agents or to red light 6. The 650nm red light intervention was not suitable for the condition evaluated by the researchers 7. are currently using atropine or similar drugs, or have stopped using them for less than 1 month
Where this trial is running
Beijing, Beijing Municipality
- Red light — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ying Jie, PhD — Beijing Tongren Hospital
- Study coordinator: Kai Cao
- Email: caozhi@ccmu.edu.cn
- Phone: 01058265900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.