The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score
研究概览
简要总结
This trial is an observational cohort study. Patients aged 8-15 years with symptomatic convergence insufficiency and 150 patients with symptomatic convergence insufficiency who had not received visual training were selected from the Tianjin Eye Hospital Optometry Center and received 1 course of visual training treatment. Self-assessment and other assessments were combined, and the patient and guardian questionnaires were collected. The EQ-5D-Y and CHU9D scales were used to evaluate Chinese patients' health-related quality of life with symptomatic convergence insufficiency. The feasibility of the EQ-5D-Y and CHU9D scales in assessing the health-related quality of life of Chinese patients with symptomatic convergence insufficiency was analyzed. To assess the effectiveness of visual training on visual symptoms and improvement of quality of life in patients with symptomatic convergence insufficiency
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8~15 years old
- •Monocular best corrected visual acuity at distance and near was more than 0.8
- •Near exophoria 4Δ greater than distance exophoria
- •NPC ≥ 6cm
- •PFV ≤15△BO
- •Stereogram ≤500 ''
- •Score of CISS questionnaire ≥16 or COVD questionnaire≥20
排除标准
- •present constant strabismus, nystagmus or vertical phoria at distance or near.
- •developmental delay or ocular surgery
- •Myopia≤ -6.00D, Hyperopia ≥ +5.00D, Astigmatism ≥ 4.00D
- •Monocular Amplitude of accommodation<5D
- •Other diseases except myopia
结局指标
主要结局
Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score
时间窗: The changes between baseline and 3 months
The EQ-5D-5L questionnaires were used to evaluate the quality of life scores of myopic patients.The health utility value can be calculated by the number of the answer to the question. 0 means death and 1 means complete health.
Changes in shortForm 6D(SF-6D) questionnaire score
时间窗: The changes between baseline and 3 months
The SF-6D questionnaires were used to evaluate the quality of life scores of myopic patients.The health utility value can be calculated by the number of the answer to the question. 0 means death and 1 means complete health.
次要结局
未报告次要终点