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临床试验/NCT05234957
NCT05234957已完成不适用

Symmetric Versus Asymmetric Bilateral Lateral Rectus Recession in Management of Basic Intermittent Exotropia With Ocular Dominance

Benha University2 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17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
2
主要终点
Ocular Alignment at Distant Fixation

研究概览

简要总结

The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance.

详细描述

Surgical management of basic -type intermittent exotropia with a dominant eye is controversial. Some surgeons do traditional symmetrical bilateral lateral rectus recession, while other perform unilateral recess-resect procedure in the non-dominant eye. The aim of this study is to investigate the effect of two different strategies of bilateral lateral rectus recession; symmetrical recession in which the amount of recession is equally divided between both eyes, and asymmetrical recession, in which the amount of recession is 2mm more in the non-dominant. Outcome measures include ocular deviation at distant and near fixation, sensory status and complications.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Basic-type intermittent exotropia
  • Simulated distant-type intermittent exotropia

排除标准

  • Alternating basic-type intermittent exotropia (no ocular dominance)
  • Distant-type intermittent exotropia
  • Convergence-insufficiency type intermittent exotropia
  • Constant exotropia
  • Sensory exotropia
  • Deep amblyopia
  • Paralytic or restrictive exotropia
  • Previous extraocular muscle surgery

结局指标

主要结局

Ocular Alignment at Distant Fixation

时间窗: one year

ocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.

Ocular Alignment at Near Fixation

时间窗: one year

ocular alignment in prism diopter (PD) at near fixation (1/3 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.

次要结局

  • Sensory Status (Stereopsis)(one year)
  • Sensory Status (Fusion)(one year)

研究者

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

Mohamed Fathy Farid

Professor

Benha University

研究点 (2)

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