Clinical trial NCT05957458: Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults
Official title: Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Amblyopia
Refractive Error - Myopia Axial
Ametropia
Keywords: Myopia
PBM therapy
LLLT
Lead sponsor: Beijing Airdoc Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 41
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Axial length shortening comparing to that value of baseline (mm）
timeFrame: 12-month
measure: Axial length shortening comparing to that value of baseline (mm）
timeFrame: 1-month
measure: Axial length shortening comparing to that value of baseline (mm）
timeFrame: 6-month
Secondary outcomes:
measure: Refractive changes at the follow-up from the baseline (D)
timeFrame: 12-month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Qiu Jenny
state: Haidian District
Study officials:
affiliation: Airdoc MPC Co, Ltd.
name: QIU JENNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.