Study on the Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies for Adult Myopia Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Axial length
研究概览
简要总结
To explore the effectiveness and safety of repeated exposure to repeated low-intensity red light
详细描述
The experiment will be divided into two phases. In the first phase, the subjects will be randomly grouped using laser equipment and LED equipment, and each group will be exposed to the red light twice a day for one month. The second stage involves self-comparison of the laser equipment, with the usage frequencies being once a day and three times a day.
To explore the effectiveness and safety of repeated exposure to repeated low-intensity red light in different devices and frequencies, as well as its impact on the axial length, spherical equivalent refraction and choroidal thickness of myopia progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-35 years old, gender not limited; Obtained informed consent.
排除标准
- •Obvious strabismus and amblyopia
- •With congenital eye disease, such as congenital cataract, congenital retinal disease
- •Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
- •Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
- •Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
- •Bnormal intraocular pressure and clinical significance (IOP <10 mmHg or IOP>21mmHg or binocular IOP difference ≥5mmHg)
- •Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
- •Optic nerve damage or congenital optic nerve dysfunction
- •Can not be regularly checked
- •The adjustment range is less than 8D or obvious near difficulties
- •Other reasons researchers think it is not suitable for inclusion in researchers
研究组 & 干预措施
The Laser Group
Use Eyerising (RS-200-2A), 1 time,2 times or 3 times a day
干预措施: Eyerising RS-200-2A (Device)
The LED Group
Use Airdoc (Sky-n1201), 2 times a day
干预措施: Airdoc Sky-n1201 (Device)
结局指标
主要结局
Axial length
时间窗: From enrollment to the end of treatment up to 7 months
次要结局
- Spherical equivalent(From enrollment to the end of treatment up to 7 months)
- Choroidal thickness(From enrollment to the end of treatment up to 7 months)
研究者
Ruihua Wei
Professor
Tianjin Medical University Eye Hospital