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

Last updated: October 7, 2024
Sponsor: Beijing Tongren Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

650 nm low-level red-light

Clinical Study ID

NCT05832723
TongrenJY2023
  • Ages 7-18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Including but not limited to the following eye diseases: strabismus, amblyopia,ocular tumors, glaucoma/macular disease and other fundus diseases (includingheredity), keratitis, eye trauma, uveitis

  2. Including but not limited to the following systemic diseases: epilepsy, tumor, heartdisease, 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 theresearchers

  7. are currently using atropine or similar drugs, or have stopped using them for lessthan 1 month

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: 650 nm low-level red-light
Phase:
Study Start date:
April 15, 2023
Estimated Completion Date:
March 28, 2026

Study 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.

Connect with a study center

  • Red light

    Beijing, Beijing 100005
    China

    Active - Recruiting

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