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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate irradiance of PBM therapy to myopia | Experimental | 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. |
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| Extra low irradiance PBM therapy group | Sham Comparator | 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. |
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| high lever PBM therapy group | Experimental | 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. |
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| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airdoc device of red light for Myopia | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| QIU JENNY, MD | Airdoc MPC Co, Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qiu Jenny | Beijing | Haidian District | 100089 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36849626 | Background | Zhou L, Tong L, Li Y, Williams BT, Qiu K. Photobiomodulation therapy retarded axial length growth in children with myopia: evidence from a 12-month randomized controlled trial evidence. Sci Rep. 2023 Feb 27;13(1):3321. doi: 10.1038/s41598-023-30500-7. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D000550 | Amblyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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Three groups are all treated with PBM therapy with follow-up but they irradiance is different while one group is as the control.
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No mask for all. Open and retrospective study.
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Without PBM therapy group.
|
| D014786 |
| Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |