Clinical Study of Light Therapy to Control Myopia Progression in Children

Last updated: July 31, 2023
Sponsor: Beijing Airdoc Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

Photobiomodualtion Therapy

Single vision spectacles for correction myopia

Clinical Study ID

NCT05761379
BeijingAirdoc
  • Ages 6-16
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is notlimited;
  2. Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D);
  3. Best corrected vision in one eye under glasses correction: 0.1 log MAR;
  4. No strabismus: no more than 15 prism constant dominance strabismus after far and nearcover tests;
  5. No myopia control measures within the previous 4 weeks: such as orthokeratology lens,gradient lens, double light lens, eye drops for myopia control (such as atropine),myopia defocus glasses, red light for myopia control, other specially designed myopialight treatment instruments or contact lenses for special design to control myopia (such as Misight);

Exclusion

Exclusion Criteria:

  1. Any ocular(including constant dominant strabismus with more than 15 prisms) andsystemic diseases or abnormalities can significantly affect visual function or promotethe progression of myopia;
  2. Other interventions for myopia control before 4 weeks before enrollment, For example,orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control,other specially designed comprehensive treatment devices, myopia, amblyopia, orspecially designed contact lenses (such as Misight), etc.
  3. Subject participated in other clinical trials within 4 weeks before the enrollment;
  4. The investigator for safety reasons or the interests of the patient, Othercircumstances in which the patient should not participate in this trial, If sufferingfrom serious heart, liver and kidney disease. -

Study Design

Total Participants: 83
Treatment Group(s): 2
Primary Treatment: Photobiomodualtion Therapy
Phase:
Study Start date:
March 28, 2023
Estimated Completion Date:
December 30, 2024

Study Description

LLLT utilized the 650-nm red light to provide sufficient energy to stimulate the tissue without causing damage to the surrounding tissues. And several researchers reported the long-term efficacy of LLLT in slowing the progression of myopia to date. These studies were reported various illumination and irradiance. This study is to test the efficacy of LLLT comparing to the control group as well as to test whether two types of lighting design will be different to the efficacy and safety.

Connect with a study center

  • Eye & ENT hospital of Fudan university

    Shanghai, Shanghai 200031
    China

    Active - Recruiting

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