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

Sponsor

Beijing Airdoc Technology Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05957458

Collaborator

(none)

300

Enrollment

Location

Arms

28.9

Actual Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia Amblyopia Refractive Error - Myopia Axial Ametropia	Device: Airdoc device of red light for Myopia	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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)

Masking Description:

No mask for all. Open and retrospective study.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate irradiance of PBM therapy to myopia 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 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. Other Names: low lever laser therapy photobiomodulation therapy low lever light therapy
Sham Comparator: Extra low irradiance PBM therapy group 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 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. Other Names: low lever laser therapy photobiomodulation therapy low lever light therapy
Experimental: high lever PBM therapy group 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 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. Other Names: low lever laser therapy photobiomodulation therapy low lever light therapy
No Intervention: Control Without PBM therapy group.

Outcome Measures

Primary Outcome Measures

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
Axial length shortening comparing to that value of baseline (mm） [1-month]
Measured with optial coherent methods with the same device assistant with the techinician
Axial length shortening comparing to that value of baseline (mm） [6-month]
Measured with optial coherent methods with the same device assistant with the same techinician

Secondary Outcome Measures

Refractive changes at the follow-up from the baseline (D) [12-month]
Spherical Equivalence were recorded with the right eyes only

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 41 Years

Sexes Eligible for Study:

All

Accepts 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