Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults

Study Overview
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Brief Summary
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Photobiomodulation therapy, that is, Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese populationb for the recent 3 years with evidence based papers and amazing results. However, there's not yet evidence to demonstrate the relationship between the dose response effect of photobiomodulation therapy on myopia control at the different age lever.

Detailed Description
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Previous trial has demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment at the irridiance of 2.3mW（2.0 2.5mW) controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Retrospective analyze other irriadance of 1.2mW, 0.6mW and 0.37mW culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.

Official Title
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Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm

Conditions
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Myopia, Amblyopia, Refractive Error - Myopia Axial, Ametropia

Intervention / Treatment
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* Device: Airdoc device of red light for Myopia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myopia or near Myopia with younger age Without other intervention of myopia control, including atropine, Misight contact lens, special design lens to control myopia, orthokeratology and other red light devices. Follow-up at least once With baseline data of ocular parameters before the follow-up Exclusion Criteria: Photophobia Allergy to red light Severe ocular progressing diseases or systemic diseases The data is unacceptable with reasonable explanations

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups are all treated with PBM therapy with follow-up but they irradiance is different while one group is as the control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate irradiance of PBM therapy to myopia<br>The PBM therapy irradiance is about 0.60mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5 10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration. | Device: Airdoc device of red light for Myopia<br>* This light is Narrow-Band, Long-Wavelength Lighting with three different illumination (400lux, 800lux, 1200lux) or irridiance (1.2mW, 0.6mW, 0.37mW) respectively. And the wavelength is 650nm. It allows biocular therapy.<br>* Other names: low lever light therapy;|
| Sham Comparator: Extra low irradiance PBM therapy group<br>The PBM therapy irradiance is about 0.37mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5 10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration. | Device: Airdoc device of red light for Myopia<br>* This light is Narrow-Band, Long-Wavelength Lighting with three different illumination (400lux, 800lux, 1200lux) or irridiance (1.2mW, 0.6mW, 0.37mW) respectively. And the wavelength is 650nm. It allows biocular therapy.<br>* Other names: low lever light therapy;|
| Experimental: high lever PBM therapy group<br>The PBM therapy irradiance is about 1.20mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5 10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration. | Device: Airdoc device of red light for Myopia<br>* This light is Narrow-Band, Long-Wavelength Lighting with three different illumination (400lux, 800lux, 1200lux) or irridiance (1.2mW, 0.6mW, 0.37mW) respectively. And the wavelength is 650nm. It allows biocular therapy.<br>* Other names: low lever light therapy;|
| No Intervention: Control<br>Without PBM therapy group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length shortening comparing to that value of baseline (mm） | Measured with optial coherent methods with the same device assistant with the same techinician | 12-month | 
| Axial length shortening comparing to that value of baseline (mm） | Measured with optial coherent methods with the same device assistant with the techinician | 1-month | 
| Axial length shortening comparing to that value of baseline (mm） | Measured with optial coherent methods with the same device assistant with the same techinician | 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive changes at the follow-up from the baseline (D) | Spherical Equivalence were recorded with the right eyes only | 12-month | 

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