A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents

Capital Medical University

Status: Enrolling

Conditions: Myopia

Treatments: Device: 650 nm low-level red-light

Study type: Observational

Funder types: Other

Identifiers

NCT05832723

TongrenJY2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

650 nm low-level red-light

Description:

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.

Treatment:

Device: 650 nm low-level red-light