EARLY SURGERY FOR CONGENITAL ESOTROPIA TRIAL

先天性内斜视是儿童斜视最常见的形式。 关于最佳时机，存在着相当大的争议 手术矫正。目前的标准临床实践是进行 在六个月或更大的时候做手术。有确凿的证据， 然而，建议在更早的年龄进行手术可能会增强 双眼视觉的发展和持续良好的眼球对准。 这项研究旨在回答主要的问题：婴儿是否患有 11-18周龄进行手术的先天性内斜视发展较好 双目视觉和眼球运动稳定性好于婴儿 在28-32周大的时候做手术？这项研究是一项简单、随机、 拟招募200名患者的单盲对照临床试验 一年之内。11-18周龄的婴儿有陪护 内斜视40多个棱镜屈光度，不早熟，神经性 正常人将在11-18周或28-32周时随机接受手术。 已制定了接近标准的后续访问计划 临床实践，建议最低就诊次数。两个小组都将 在术后一周和一个月时、一岁时和 在研究期间，每六个月进行一次。最早的 手术组也将在9个月大时进行评估。更频繁 访问将由调查人员根据具体情况酌情决定 凯斯。主要结果是在4-5岁时测量立体锐度 蒙面观察者使用随机2号测试和蒂姆斯飞行测试，两者都是 广泛应用于临床实践。这将确保不偏不倚 将对结果进行标准化评估。次要结果 包括眼运动对准、相关运动异常 再操作、融合和压制(用四点价值衡量 近距离测试和巴戈里尼透镜测试)。

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).