The Effect of Orthokeratography on the Quality of Life and Behavior of Myopic Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in EuroQol five dimensions questionnaire(EQ-5D-Y) score
研究概览
简要总结
The study intended to observe the changes in the quality of life, behavior, and eye habits of children and adolescents aged 8-18 years before and after orthokeratology, as well as the differences in the quality of life and behaviors of different myopic groups after keratoplasty, using the EQ-5D-Y, CHU9D, and CHROME-G scales with the use of a self-assessment method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spherical equivalent ranged -1.00D from-5.00D
- •Optimal corrected visual acuity ≥1.0 in both eyes
- •No apparent strabismus or other eye disease
- •Able to read Chinese and communicate in Mandarin, able to understand the questions in the questionnaire
排除标准
- •A history of corneal surgery within 1 year
- •Eyelid abnormalities or infection
- •An inability to wear orthokeratology
- •Use medications that affect the wear of eye and corneal contact lenses
- •Those who have participated in a clinical trial of a drug within 90 days
- •Allergic patients who have used contact lenses and/or care products
- •The researchers consider it inappropriate to participate in this program
结局指标
主要结局
Changes in EuroQol five dimensions questionnaire(EQ-5D-Y) score
时间窗: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.
Changes in the Child Health Utility 9D (CHU9D) score
时间窗: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.
次要结局
未报告次要终点