NCT05957458: MCPT

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

Completed NA Last updated 24 July 2023

What this trial tests

NA trial testing Airdoc device of red light for Myopia in Myopia in 300 participants. Completed in 31 May 2023.

Timeline

1 January 2021

Primary endpoint
31 December 2022

31 May 2023

Quick facts

Lead sponsor	Beijing Airdoc Technology Co., Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 January 2021
Primary completion	31 December 2022
Estimated completion	31 May 2023
Sites	1 location across China

Drugs / interventions tested

• Airdoc device of red light for Myopia

Conditions studied

• Myopia — all drugs for Myopia →
• Amblyopia — all drugs for Amblyopia →
• Refractive Error - Myopia Axial — all drugs for Refractive Error - Myopia Axial →
• Ametropia — all drugs for Ametropia →

Sponsor

Beijing Airdoc Technology Co., Ltd.

Who can join

Adults 4 to 41, any sex, with Myopia or Amblyopia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real World Study of Cumulative Absolute Reduction in Axial Elongation (CARE) afterPhotobiomodulation Therapy
   Zhou L, David C, Li Y, Tong L, et al · · 2023 · DOI 10.21203/rs.3.rs-3644537/v1