Exploring the Repeatability of Adaptive Optics Scanning Laser Ophthalmoscope Technology (AO-SLO Mona IIa) and the Differences in Cone Cell Density Between Individuals Who Undergone and Not Undergone Repeated Low-level Red-light
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The density of cone cells
研究概览
简要总结
To explore the repeatability of AO-SLO (Mona IIa) technology and the difference of cone cell density between individuals who used or not used repeated low-intensity red light treatment
详细描述
This study focuses on the population with long-term use of repetitive low-intensity myopia, exploring the safety of repetitive low-intensity red light over a long period of use, and providing data support and clinical guidance for the field of repetitive low-intensity red light. It investigates the repeatability of adaptive optics scanning laser ophthalmoscope technology and observes the safety of repetitive low-intensity red light treatment for children over a long period of use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 - 55 years old, gender not limited; Obtained informed consent.
排除标准
- •Children with 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
RLRL group
Use RLRL (Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China)
干预措施: RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China)) (Device)
No RLRL Group
No use RLRL
结局指标
主要结局
The density of cone cells
时间窗: From enrollment to the end of treatment at 3 weeks
次要结局
- Repeatability of adaptive optics scanning laser ophthalmoscope technology of cone cell density(From enrollment to the end of treatment at 3 weeks)
研究者
Ruihua Wei
Professor
Tianjin Medical University Eye Hospital