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临床试验/NCT06221098
NCT06221098已完成不适用

Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital

Sohag University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
residual esotropia

研究概览

简要总结

Strabismus (or squint) is defined as the presence of misalignment between the visual axes of the 2 eyes presenting with deviation of the eyes. Strabismus is further subdivided into comitant (if the amount of misalignment between the 2 eyes remained equal in all directions of gaze) and incomitant (if the amount of misalignment varied in different directions of gaze). If the squinting eye was deviated inward, it is termed as a convergent squint or esotropia and if the squinting eye is deviated outward, it is termed as a divergent squint or exotropia. Pediatric esotropia may be congenital or acquired. Congenital esotropia is a well-defined entity with an onset prior to 6 months of age, characterised by a large stable angle, cross fixation, and a limited potential for binocular single vision. Acquired childhood esotropia may be paralytic or non-paralytic. The non-paralytic or concomitant type, which is neither congenital nor secondary to ocular pathology, can be divided into three main groups: (1) Accommodative esotropia, which may be fully accommodative, partially accommodative, or accommodative with convergence excess; (2) Non-accommodative esotropia; (3) Esotropia associated with neurological dysfunction, in particular cerebral palsy and hydrocephalus. The last group of esotropia will be excluded from our study. Pediatric strabismus must be treated early to maximize the potential for binocular vision and decrease the risk of amblyopia. Treatment goals include good vision in each eye (no amblyopia) and straight eyes (orthotropia). Both conditions are necessary to produce stereopsis, which is a third goal. Strabismus in children may result in undesirable appearance, amblyopia, impaired stereopsis, diplopia, and negative psychological effect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Infants and children up to the age of 12 years.
  • Primary Concomitant convergent squint (1ry concomitant esotropia)
  • Candidate for surgical correction of squint

排除标准

  • Children with:
  • Paralytic squint
  • Consecutive esotropia
  • Any neurological disorders e.g. hydrocephalus.
  • History of previous squint surgery
  • History of previous other ocular surgery (e.g. congenital cataract & glaucoma)
  • Children who missed follow up.

结局指标

主要结局

residual esotropia

时间窗: 6months

esotropia \>10PD undercorrection

orthotropia

时间窗: 6 months

eye alignment

consecuative exotropia

时间窗: 6 months

exotropia \> 10PD overcorrection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abeer Nasser Mazen

resident of ophthalmology department el helal hospital

Sohag University

研究点 (1)

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