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

Myopia Clinical Trial

— MCPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957458
• Other study ID #: Airdoc MPC Co.Ltd.
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: Beijing Airdoc Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 41 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia
• Ametropia
• Myopia
• Refractive Error - Myopia Axial
• Refractive Errors

Intervention

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.

Locations

Country	Name	City	State
China	Qiu Jenny	Beijing	Haidian District

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Airdoc Technology Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Refractive changes at the follow-up from the baseline (D)	Spherical Equivalence were recorded with the right eyes only	12-month