Effect of "eye" Education for Parents on Myopia Prevention and Control in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- Axial Length
研究概览
简要总结
This is a randomized controlled trial aimed to explore the effect of behavioral interventions based on doctors' and nurses' health education on the onset and development of myopia in children's. Participants were randomly assigned to one of two groups: eye health intervention, or the control group. Intervention group's parents would reveive eye health education in response to their children's myopia progression at baseline, 1 month, 3 months, and 6 months, while the control group did not receive any. Visual acuity, cycloplegic refraction, axial length, Strengths and Difficulties Questionnaire, and Generalized Anxiety Disorder 7-item Scale were the main outcomes and measures.
详细描述
After doctors' and nurses' education, parents would keep a diary to regulate the children's "Sedentary", "Sunshine", "Sleep", "Screen", and "Stress" that is, the "5S" eye education. To urging parents pay attention to the children's eye behavior every day, and targeted to children "eye" education to delay the occurrence and development of myopia and reduce the incidence of high myopia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 5-17;
- •Removing flexible lenses for at least 1 week, flexible astigmatism and hard lenses for at least 3 weeks, orthokeratology lenses for at least 3 months;
- •Best corrected visual acuity of either eye were all ≥ 1.0;
- •The range of myopia in either eye was -15 D ≤ SE ≤ +2.0 D;
- •Astigmatism of either eye less than -5.0 D;
- •Anisometropia ≤ -1.5 D;
- •There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.
- •Intraocular pressure of either eye is of 10 to 21 mmHg;
- •On the basis of full understanding, children and their guardians sign the informed consent;
排除标准
- •Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for children over 6 years old;
- •Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
- •Secondary myopia, genetic disease or connective tissue- related myopia;
- •Moderate or severe ptosis;
- •Congenital cataract, glaucoma;
- •Other fundus diseases other than myopic related fundus lesions;
- •Intraocular or refractive surgery history;
- •The refractive medium is turbid, and it is impossible to take a clear fundus image; (9)Unable to cooperate with fundus image shooting and other examination;
- •(10)Do not receive cycloplegia or have contraindications; (11)Poor overall condition, unable to follow up for a long time; (12)The subject refuses to participate in the research; (13)Other cases in which the researcher judges that it is not suitable for participation in the study.
结局指标
主要结局
Axial Length
时间窗: Baseline, 1 month, 3 months, 6 months.
Ocular biometry was used for measuring the axial length, which is the physical distance between the anterior corneal pole and the retinal structure at the posterior pole.
Cycloplegic Refraction
时间窗: Baseline, 1 month, 3 months, 6 months.
Cycloplegic refractive errors were measured with an autorefractor.
次要结局
- Visual acuity(Baseline, 1 month, 3 months, 6 months.)
- Anxiety Disorder Screening 7-item Scale(Baseline, 6 month)
- Strengths and Difficulties Questionnaire(Baseline, 6 month.)
研究者
Shi-Ming Li
Professor
Beijing Tongren Hospital