Effect of Age at Time of Surgery on the Surgical Outcome After Bilateral Lateral Rectus Muscle Recession in Intermittent Exotropia
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 主要终点
- Motor success rate
研究概览
简要总结
It is prospective cohort study to compare ( the surgical outcome) the motor and sensory outcome of early surgery (≤5 years of age) and late surgery ( ≥ 7 years of age) for intermittent exotropia.
详细描述
Sample Size:
One hundred and twenty four patients with intermittent exotropia will be included in this study in form of two groups based on the age at the first surgery; each group including 62 patients
- Group I patients ≤ 5 years of age
- Group II patients ≥ 7 years of age
Sample size calculation:
We are planning a study of independent cases and controls with 1 control(s) per case. Prior data indicate that the success rate among adults is 0.75. If the success rate for the young age group is 0.5, we will need to study 58 adult subjects and 58 young subjects to be able to reject the null hypothesis that the success rates for young and adult subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use an uncorrected chi-squared statistic to evaluate this null hypothesis. Assuming a dropout rate of 5 %, a total of 62 patients will be recruited in each group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with intermittent exotropia in whom surgery is indicated
排除标准
- •Patients with prior eye muscle surgery, restrictive or paralytic strabismus will be excluded. In addition, patients with craniofacial anomalies or neurological problems
结局指标
主要结局
Motor success rate
时间窗: Six months
Success rate defined as deviation between exotropia/phoria of 8 PD to esotropia/phoria of 4 PD
次要结局
- New misalignment(Six months)
- Change in stereoacuity(Six months)
- Pattern deviation(Six months)
研究者
Ahmed Awadein
Professor of Ophthalmology
Cairo University