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临床试验/NCT04308538
NCT04308538Unknown不适用

Bilateral Lateral Rectus Recession Using Standard Tables Versus Bilateral Lateral Rectus Recession Using Modified Reduced Numbers in Intermittent Exotropia in Children Less Than 6 Years Old

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Motor success rate

研究概览

简要总结

comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter

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
Single (Participant)

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9)
  • Basic, pseudo- divergence excess and divergence excess types are included.
  • If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector).

排除标准

  • Intermittent exotropia of the convergence insufficiency type.
  • Intermittent exotropia with angle of deviation greater than 50 prism diopters.
  • Patients with previous squint surgery.
  • Patients with secondary deviation due to a sensory lesion or neurological condition.

结局指标

主要结局

Motor success rate

时间窗: 6 months

Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)

次要结局

  • Pattern strabismus(6 months)

研究者

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

Ahmed Awadein

Prof.Ahmed Awadein

Cairo University

研究点 (1)

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