Effect of 650nm Low Energy Light on Macular Microcirculation in Myopia Prevention and Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Choroid thickness
研究概览
简要总结
This project is a single-center, prospective, self-controlled clinical study. It intends to select patients with simple medium and low degree myopia as subjects, and apply 650nm low-energy red light irradiation to the retina to observe its effect on macular microcirculation.
详细描述
A total of 120 subjects are planned to be recruited and divided into 4 groups according to age and intervention, including 30 in the juvenile intervention group, 30 in the juvenile control group, 30 in the adult intervention group and 30 in the adult control group. Two intervention groups received 650nm low-energy red light irradiation treatment with a 650nm low-energy light emitter, twice a day for 3 minutes each time, The subjects were treated and followed up for 3 months. The control group was not treated and followed up for 3 months too. All subjects were followed up before treatment, at the end of the 1st month and at the end of 3rd month. Angio-oct was used as the main examination to observe and record the vascular density and blood perfusion in macular area. Axial length, diopter and OCT were used as secondary observation indexes. At the end of the experiment, the data of the intervention group and the control group were compared
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
- None
入排标准
- 年龄范围
- 7 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 7 to 17 years old or from 18 to 45 years old;
- •Meet the diagnostic criteria for patients with simple low or moderate myopia, with diopter < -6.0d and eye axis < 26.0mm;
- •Transparent refractive stroma, no other eye diseases except nearsightedness;
- •Agree to participate in the clinical study and sign the informed consent.
排除标准
- •Other ocular lesions, such as uveitis, retinal/choroidal vascular lesions, congenital ocular lesions, glaucoma, high myopia (ocular axis > 26cm), degenerative retinal disease, optic neuropathy, etc.;
- •Another eye with low vision
- •Corneal edema/epithelial detachment, corneal opacity;
- •Redness, pain, dry eye, photophobia, difficulty in opening eyes;
- •Had a history of eye surgery in recent 3 months;
- •Severe impairment of liver and kidney function and/or serious systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc.);
- •Women who are already pregnant, preparing for pregnancy during the study period and lactating;
- •A history of substance abuse or alcohol abuse;
- •Receiving prevention and control treatment for myopia other than glasses within the first 30 days;
- •Any situation in which the study physician believes that the patient's condition will interfere with the clinical study (e.g., the patient is prone to nervous tension, uncontrollable emotions, depression, etc.)
结局指标
主要结局
Choroid thickness
时间窗: 12 weeks
Distance from Bruch membrane to The inner surface of the sclera
retinal vascular density
时间窗: 12 weeks
The vascular density of the inner retinal layer in the macular area within 3×3mm was measured by angio-OCT
retinal vascular perfusion
时间窗: 12 weeks
The perfusion of the inner retinal layer in the macular area within 3×3mm was measured by angio-OCT
次要结局
- diopter(12 weeks)
- Axial length(12 weeks)
研究者
jun ren
Attending doctor,Principal Investigator
Central South University