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RECRUITING
NCT05832723

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

Sponsor: Beijing Tongren Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

7 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2023-04-15

Completion Date

2026-03-28

Last Updated

2024-10-08

Healthy Volunteers

Yes

Conditions

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

Locations (1)

Red light

Beijing, Beijing Municipality, China