Early Versus Delayed Surgery for Infantile Esotropia: A Clinical Evaluation of Sensory and Motor Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Motion visual evoked potential (mVEPs) asymmetry
研究概览
简要总结
The goal of this study is to determine whether corrective surgery done earlier than the current standard can better improve the visual and eye movement deficits in children with infantile esotropia (crossed eyes in infancy).
详细描述
While there is a uniform agreement among pediatric ophthalmologists that most infantile esotropia requires surgical correction, the proper timing of surgery is controversial. In North America, the typical age at surgery ranges from 11-18 months. Unfortunately, despite successful surgical realignment of the eyes, the sensory and eye movement deficits often persist. Recently, some pediatric ophthalmologists have advocated earlier surgery. The rationale for early surgery stems from animal and human research showing that early realignment of the eyes within an early critical period allows normal development of the sensory and eye movement systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •onset of esotropia after 10 weeks of age;
- •constant esotropia ≥ 20° (40 prism diopter or PD) at near (1/3 m) on two examinations, separated by 2-4 weeks; and
- •refractive error ≤ +3.00 diopters (far-sightedness).
排除标准
- •gestational age < 34 weeks;
- •birth weight ≤ 1500 g;
- •ventilator treatment in the newborn period;
- •history of meningitis or other major medical event;
- •developmental delay;
- •incomitant or paralytic strabismus;
- •manifest nystagmus or head bobbing;
- •prior eye muscle surgery;
- •prior treatment of amblyopia or spectacle correction for refractive errors;
- •presence of structural ocular anomalies.
结局指标
主要结局
Motion visual evoked potential (mVEPs) asymmetry
时间窗: at age 2 years
mVEP measures the perception of nasalward and temporalward motion for each eye at the cortical level. A nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better for one direction over the other.
Optokinetic nystagmus (OKN) asymmetry
时间窗: at age 5 years
OKN is measured in both the nasalward and temporalward directions for each eye. From this a nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better in one direction or the other.
Global Motion Perception
时间窗: at 2 and 5 years of age
Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).
Stereopsis
时间窗: at 2 and 5 years of age
This measures the level of 3D depth perception.
次要结局
未报告次要终点
研究者
Agnes Wong
Ophthamologist-In-Chief
The Hospital for Sick Children