A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 650 nm low-level red-light.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 7 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device 650 nm low-level red-light
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 enro
Primary outcome measures
- Change in axial length [Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
- Change in spherical equivalent error [Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Red light — Beijing
Identifiers
NCT: NCT05832723 · TongrenJY2023