Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults
- Conditions
- MyopiaAmblyopiaRefractive Error - Myopia AxialAmetropia
- Interventions
- Device: Airdoc device of red light for Myopia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
- Arm && Interventions
Group Intervention Description Extra low irradiance PBM therapy group Airdoc device of red light for Myopia The PBM therapy irradiance is about 0.37mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration. Moderate irradiance of PBM therapy to myopia Airdoc device of red light for Myopia The PBM therapy irradiance is about 0.60mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration. high lever PBM therapy group Airdoc device of red light for Myopia The PBM therapy irradiance is about 1.20mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.
- 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