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RMC: Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old

Sponsor
Beijing Airdoc Technology Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05811598
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
21.4
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported.

Condition or Disease Intervention/Treatment Phase
  • Device: repeated ultra low lever red light
 N/A

Detailed Description

Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported. Here we design this control and random prospective study to find the two types light with different irridance to two ages (34 years old and 56 years old) respectively. Wether the dose and effectiveness exit or not for 3~6- year- old myopia control.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two groups for the 2 lighting lever (0.37mW and 0.6mW）for 2 groups of ages (3~4 years old and 5~6 years old)two groups for the 2 lighting lever (0.37mW and 0.6mW）for 2 groups of ages (34 years old and 56 years old)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Random、Control and Open Study of Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
Actual Study Start Date :
Mar 21, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: repeated red light therapy for 3~4 year-old myopia

0.37mW lighting with wavelength of 650nm for the age of 3~4 years old(including both 3 and 4 years)myopia.

Device: repeated ultra low lever red light
Myopia indoor lighting therapy
Other Names:
  • LLLT, PBM therapy

    		•
    Experimental: repeated red light therapy for 5~6 year-old myopia

    0.60mW lighting with wavelength of 650nm for the age of 5~6 years old(including both 5 and 6 years)myopia.

    Device: repeated ultra low lever red light
    Myopia indoor lighting therapy
    Other Names:
  • LLLT, PBM therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Axial length changes from baseline (mm) [3-month and 6-month]

      Ocular axial length measured by IOLmaster will be measured and recorded at follow-up and at baseline. The changes values of axial length will be compared as the main outcome to compare the effectiveness of repeated red light thearpy

    Secondary Outcome Measures

    1. Refraction changes from baseline(D) [3 and 6 month]

      Cycloplegic refraction changes from baseline will be measured and recorded at follow-up and at baseline

    2. Safety issues [6 month]

      Adverse event and device failure rate

    Other Outcome Measures

    1. Compliance [1-month]

      twice daily with 4 or more hours interview, 3minutes at each session

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 3~6 years old;

    • Myopia Spherical Equivalence Refraction <=-0.50D;

    • Written Informed Consent;

    Exclusion Criteria:

    • Cannot approval with written informed consent;

    • Photophobia or allergy to red light;

    • With other severe conditions the principle investigators refused to enroll this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Women and Children's Medical Center Guangzhou Guangdong China 510600

    Sponsors and Collaborators

    • Beijing Airdoc Technology Co., Ltd.

    Investigators

    • Study Director: Chao He, PhD, Beijing Airdoc Technology Co., Ltd.
    • Principal Investigator: Daoman Xiang, MD, PhD, Guangzhou Women and Children's Medical Center
    • Study Chair: Wensi Shen, MD, PhD, Guangzhou Women and Children's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Airdoc Technology Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05811598
    Other Study ID Numbers:
    • Beijing Airdoc Technology Co.,
    First Posted:
    Apr 13, 2023
    Last Update Posted:
    Apr 13, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Beijing Airdoc Technology Co., Ltd.
    Myopia; Children; LLLT; PBM
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Apr 13, 2023