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

Random、Control and Open Study of Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia; Amblyopia
• Intervention / Treatment: Device: repeated ultra low lever red light

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 (3~4 years old and 5~6 years old) respectively. Wether the dose and effectiveness exit or not for 3~6- year- old myopia control.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wensi Shen, MD,PhD; Phone Number: +8613631318044; Email: 369353779@QQ.COM
• Study Contact Backup: Name: Jenny QIU, MD; Phone Number: +8618510386815; Email: qiukaikai0620@airdoc.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510600
      • Recruiting
      • Guangzhou Women and Children's Medical Center
      • Contact: Wensi Shen, MD. & Ph.D.; Phone Number: +8613631318044; Email: 369353779@qq.com
      • Contact: Daoman Xiang, MD & PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean changes of axial length vaules by millimeter at follow-up from baseline.	Ocular axial length measured by IOLmaster500 or Lenstar will be measured and recorded at follow-ups and at baseline. The changes values of axial length of both groups will be compared as the main outcome to compare the effectiveness of repeated red light thearpy.	at 3-month and at 6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D)	Cycloplegic refraction changes from baseline will be measured and recorded at follow-up and at baseline. Spherical equivalence will be calculated with the formular of SE=spherical diopter+1/2cylinder diopter	at 3-month and at 6-month
Number of Participants with unsafety issues during the study	Adverse event and device failure rate	at 6-month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of subjects meet with repeated red light thearpy greater than 85% of the specified requirementsfrequence record	Twice daily with an interval of 4 hours or mor, and 3 minutes at each session	at 1-month, 3-month and 6-month

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Children; LLLT; Myopia; PBM
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Vision Disorders; Myopia; Amblyopia
• Other Study ID Numbers: Beijing Airdoc Technology Co.,

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No