Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Axial length shortening comparing to that value of baseline (mm）
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No mask for all. Open and retrospective study.
Eligibility Criteria
- Ages
- 4 Years to 41 Years (Child, Adult)
- Sex
- 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
Exclusion Criteria
- •Photophobia
- •Allergy to red light
- •Severe ocular progressing diseases or systemic diseases
- •The data is unacceptable with reasonable explanations
Outcomes
Primary Outcomes
Axial length shortening comparing to that value of baseline (mm）
Time Frame: 6-month
Measured with optial coherent methods with the same device assistant with the same techinician
Secondary Outcomes
- Refractive changes at the follow-up from the baseline (D)(12-month)