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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myopia, Amblyopia

Intervention / Treatment
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* Device: repeated ultra low lever red light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: repeated red light therapy for 3 4 year-old myopia<br>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<br>* Myopia indoor lighting therapy<br>* Other names: LLLT, PBM therapy;|
| Experimental: repeated red light therapy for 5 6 year-old myopia<br>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<br>* Myopia indoor lighting therapy<br>* Other names: LLLT, PBM therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Children, LLLT, PBM