RecruitingNCT05832723

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

Sponsor

Beijing Tongren Hospital

Enrollment

2,000 participants

Start Date

Apr 15, 2023

Study Type

OBSERVATIONAL

Conditions

Myopia

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. 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.

Eligibility

Min Age: 7 YearsMax Age: 18 Years

Inclusion Criteria4

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 Criteria7

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

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Interventions

DEVICE650 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 enrolled in a study, they would receive the intervention in the same manner and intensity if they were not enrolled in the study.