A Randomized Controlled Trial of Auricular Point Pressing With Pellets for Children With Insufficient Hyperopia Reserve
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 380
- 主要终点
- Change in Axial Length from Baseline
研究概览
简要总结
This project aims to address the trend of early onset and high myopia among children in China by focusing on insufficient hyperopia reserve, a key early warning indicator for myopia. A randomized controlled trial (RCT) will be conducted. The study will target children aged 4 to 14 with insufficient hyperopia reserve (equivalent spherical lens -0.50D to +0.75D). Through a prospective RCT design, the efficacy and safety of auricular point pressure therapy, low-concentration atropine eye drops, and their combination in delaying the onset of myopia will be systematically evaluated.
详细描述
A total of 380 subjects are planned to be included and randomly divided into auricular point pressure pill group, atropine group, combined group and control group. The follow-up period is 18 months (12 months of intervention + 6 months after intervention). The primary endpoints are changes in spherical equivalent and axial length of the eye. The secondary endpoints include intraocular pressure, astigmatism and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) obtaining written informed consent signed by children and legal guardians;(2) children aged 4 to 14 years old;(3) computer optometry after ciliary muscle paralysis detects that the equivalent spherical power of any eye is between -0.50D and 0.75D (4) there are no other organic diseases affecting vision in both eyes;(5) binocular intraocular pressure ≤ 21mmHg.
排除标准
- •(1) subjects who have been diagnosed with myopia (2) subjects who may have eye diseases that affect vision or refractive errors (such as cataract and other lens injury diseases, glaucoma, macular degeneration, keratopathy, retinal detachment, severe vitreous opacity, etc.);(3) systemic diseases: central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function, 8 severe liver and kidney dysfunction;(4) Binocular or monocular with dominant strabismus or any other pathological changes of the eye or acute inflammatory diseases of the eye;(5) allergic to atropine, compound Tobicamide and other drugs used in this study;(6) those who have participated in clinical trials of other drugs within 3 months before screening;(7) other conditions that the researchers think are not suitable.
研究组 & 干预措施
Ear acupoint pressure pellet intervention group
A prospective randomized controlled trial (RCT) design was adopted. The study subjects were children with insufficient accommodative reserve (aged 4-14 years). For the children in this group, auricular acupressure pills were administered.
干预措施: Ear acupoint pressure pellet intervention group (Behavioral)
Atropine intervention group
A prospective randomized controlled trial (RCT) design was adopted, with children (aged 4-14 years) with insufficient myopia reserve as the research subjects. For the children in this group, low-concentration atropine eye drops were administered.
干预措施: Atropine intervention group (Drug)
Joint Intervention Group
Received both auricular acupressure pill intervention and atropine intervention simultaneously
干预措施: Joint intervention Group (Combination Product)
control group
Only standardized eye hygiene education is provided (such as increasing outdoor activity time, controlling the duration and posture of close-up eye use, and ensuring adequate sleep, etc.), and no auricular acupressure or medication intervention is carried out.
干预措施: control group (Other)
结局指标
主要结局
Change in Axial Length from Baseline
时间窗: 24 months
Axial length will be measured using the IOLMaster 700 at baseline and 6 months after intervention, and the difference between the two measurements will be calculated
Change in Spherical Equivalent Refraction
时间窗: 24 months
Measured by an auto-refractor at baseline and 6 months after intervention to assess the progression of myopia
次要结局
未报告次要终点
研究者
Fangbiao Tao
professor
Anhui Medical University