EARLY SURGERY FOR CONGENITAL ESOTROPIA TRIAL

先天性内斜视是儿童斜视最常见的形式。 在最佳时机方面存在相当大的争议， 手术矫正 目前的标准临床实践是执行 在六个月大或更大时进行手术。 有充分的证据， 然而，建议在更早的年龄进行手术可能会提高 双眼视觉的发展和持续良好的眼睛对准。 这项研究旨在回答一个主要问题： 先天性内斜视在11-18周时接受手术的发育更好 双眼视觉和眼运动稳定性优于婴儿， 在28-32周时做手术？ 这项研究是一个简单的，随机的， 拟招募200例患者的对照单盲临床试验 一年内 11-18周的婴儿， 内斜视超过40棱镜屈光度，不过早，神经性 正常的将在11-18周龄或28-32周龄时随机进行手术。 随访访视时间表已确定为接近标准 临床实践，提出最低访视次数。 两组将 在手术后一周和一个月、一岁时进行检查， 在研究期间每六个月进行一次。 早期 手术组也将在9月龄时进行评估。 更频繁 访视将由研究者根据具体的 案子 主要结果是在4-5岁时测量的立体视敏度， 使用Randot 2测试和Titmus飞行测试的蒙面观察者， 广泛应用于临床实践。这将确保公正的 将获得标准化的结果评估。 次要结局 包括眼运动对准、相关运动异常 再手术，融合和抑制（用Worth四点测量） 近距离试验和Bagolini透镜试验）。

Congenital esotropia is the most common form of childhood strabismus. Considerable controversy exists in regard to the optimal timing of surgical correction. Current standard clinical practice is to perform surgery at six months of age or later. There is substantial evidence, however, to suggest that performing surgery at an earlier age may enhance the development of binocular vision and sustained good ocular alignment. This study is designed to answer the primary question: Do infants with congenital esotropia who have surgery at 11-18 weeks of age develop better binocular vision and have better ocular motor stability than infants who have surgery at 28-32 weeks of age? the study is a simple, randomized, controlled single-masked clinical trial intending to recruit 200 patients within one year. Infants between 11-18 weeks of age with comitant esotropia more than 40 prism diopters, not premature, and neurologically normal will be randomized to surgery at 11-18 weeks or 28-32 weeks of age. The follow up visit schedule has been established to approximate standard clinical practice, proposing a minimum number of visits. Both groups will be examined at one week and one moth after surgery, at one year of age and every six months after that for the duration of the study. The early surgery group will also be evaluated at 9 months of age. more frequent visits will be at the discretion of the investigator based on the specific case. the primary outcome is stereo acuity measured at age 4-5 years by a masked observer using the Randot 2 test and the Titmus fly test, both widely used in clinical practice. This will assure that unbiased standardized assessments of outcome will be obtained. Secondary outcomes include ocular motor alignment, associated motor abnormalities, reoperations, and fusion and suppression (measured with the Worth four-dot test at near and Bagolini lens test).