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

NCT05832723 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-10-08

No results posted yet for this study

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.

Conditions

  • Myopia

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.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Ying Jie, PhD · Beijing Tongren Hospital

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2026-03-28
Completion
2026-03-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832723 on ClinicalTrials.gov