Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Axial length shortening comparing to that value of baseline (mm）
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No mask for all. Open and retrospective study.
入排标准
- 年龄范围
- 4 Years 至 41 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Photophobia
- •Allergy to red light
- •Severe ocular progressing diseases or systemic diseases
- •The data is unacceptable with reasonable explanations
研究组 & 干预措施
Moderate irradiance of PBM therapy to 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.
干预措施: Airdoc device of red light for Myopia (Device)
Extra low irradiance PBM therapy group
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.
干预措施: Airdoc device of red light for Myopia (Device)
high lever PBM therapy group
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.
干预措施: Airdoc device of red light for Myopia (Device)
Control
Without PBM therapy group.
结局指标
主要结局
Axial length shortening comparing to that value of baseline (mm）
时间窗: 6-month
Measured with optial coherent methods with the same device assistant with the same techinician
Axial length shortening comparing to that value of baseline (mm）
时间窗: 12-month
Measured with optial coherent methods with the same device assistant with the same techinician
Axial length shortening comparing to that value of baseline (mm）
时间窗: 1-month
Measured with optial coherent methods with the same device assistant with the techinician
次要结局
- Refractive changes at the follow-up from the baseline (D)(12-month)