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

Not Applicable

Completed

• Conditions: Myopia; Amblyopia; Refractive Error - Myopia Axial; Ametropia

• Registration Number: NCT05957458
• Lead Sponsor: Beijing Airdoc Technology Co., Ltd.

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study First Submitted: 2023-05-23
• Study Completion: 2023-05-31
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial length shortening comparing to that value of baseline (mm）	6-month	Measured with optial coherent methods with the same device assistant with the same techinician

Secondary Outcome Measures

Name	Time	Method
Refractive changes at the follow-up from the baseline (D)	12-month	Spherical Equivalence were recorded with the right eyes only

Trial Locations

Locations (1)

Qiu Jenny; 🇨🇳 Beijing, Haidian District, China