Amblyopia, Ametropia, Myopia, Refractive Error - Myopia Axial
Conditions
Keywords
Myopia, PBM therapy, LLLT
Brief summary
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
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.
Interventions
DEVICEAirdoc device of red light for Myopia
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.
Sponsors
Beijing Airdoc Technology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No mask for all. Open and retrospective study.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 41 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length shortening comparing to that value of baseline (mm） | 12-month | Measured with optial coherent methods with the same device assistant with the same techinician |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Refractive changes at the follow-up from the baseline (D) | 12-month | Spherical Equivalence were recorded with the right eyes only |
Countries
China
Outcome results
None listed