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

Not Applicable

Recruiting

• Conditions: Myopia; Amblyopia
• Interventions: Device: repeated ultra low lever red light

• Registration Number: NCT05811598
• Lead Sponsor: Beijing Airdoc Technology Co., Ltd.

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.

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 Timeline

• Study Start: 2023-03-21
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Status Verified: 2023-04
• Study First Posted: 2023-04-13
• Last Update Submitted: 2023-04-22
• Last Update Posted: 2023-04-25
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repeated red light therapy for 3~4 year-old myopia	repeated ultra low lever red light	0.37mW lighting with wavelength of 650nm for the age of 3\~4 years old(including both 3 and 4 years)myopia.
repeated red light therapy for 5~6 year-old myopia	repeated ultra low lever red light	0.60mW lighting with wavelength of 650nm for the age of 5\~6 years old(including both 5 and 6 years)myopia.

Primary Outcome Measures

Name	Time	Method
Mean changes of axial length vaules by millimeter at follow-up from baseline.	at 3-month and at 6-month	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.

Secondary Outcome Measures

Name	Time	Method
Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D)	at 3-month and at 6-month	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
Number of Participants with unsafety issues during the study	at 6-month	Adverse event and device failure rate

Trial Locations

Locations (1)

Guangzhou Women and Children's Medical Center; 🇨🇳 Guangzhou, Guangdong, China