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

Myopia Clinical Trial

— RMC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811598
• Other study ID #: Beijing Airdoc Technology Co.,
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2023
• Source: Beijing Airdoc Technology Co., Ltd.
• Contact: Wensi Shen, MD,PhD
• Phone: +8613631318044
• Email: 369353779[@]QQ.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia
• Myopia

Intervention

Device:
• repeated ultra low lever red light
Myopia indoor lighting therapy

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Airdoc Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Number of Participants with unsafety issues during the study	Adverse event and device failure rate	at 6-month