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

Myopia Clinical Trial

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

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05832723
Study type Observational
Source Beijing Tongren Hospital
Contact Kai Cao
Phone 01058265900
Email caozhi@ccmu.edu.cn
Status Recruiting
Phase
Start date April 15, 2023
Completion date March 28, 2026
View Details
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