Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-29 @ 9:47 AM
Study NCT ID:
NCT05957458
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults
Sponsor:
Beijing Airdoc Technology Co., Ltd.
Organization:
Study Overview
Official Title:
Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCPT
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: