跳至主要内容
临床试验/NCT03240107
NCT03240107已完成不适用

Standard Levator Aponeurosis / Muscle Resection With Three Point Fixation Versus Two Point Fixation Tucking for Congenital Ptosis With Fair to Good Levator Function

Heba Hamdy Ibrahim Mohammed1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1

研究概览

简要总结

to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis

详细描述

Target population for the study is children under twelve years old presenting to ophthalmology clinic at Cairo university specialized pediatric hospital with congenital ptosis.

Patients will be randomly divided into two groups First group (A) will contain 20 patients who will undergo standard levator aponeurosis resection Second group (B) will contain 20 patient who will undergo two point fixation levator tucking

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
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Unilateral or bilateral simple isolated congenital ptosis.
  • Levator function more than 4mm

排除标准

  • Congenital ptosis associated with other ocular syndromes.
  • Recurrent ptosis following any attempt for repair.
  • Traumatic ptosis or acquired ptosis
  • ve bell's phenomenon.

研究组 & 干预措施

levator resection

Active Comparator

20 patients who will undergo levator aponeurosis resection technique

干预措施: levator resection (Procedure)

levator tucking

Active Comparator

20 patients who will undergo two point fixation levator tucking technique

干预措施: levator tucking (Procedure)

结局指标

主要结局

Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1

时间窗: 6 to 9 months

MRD1:distance between upper lid margin and corneal light reflex measured in mm by transparent ruler

次要结局

未报告次要终点

研究者

发起方
Heba Hamdy Ibrahim Mohammed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Heba Hamdy Ibrahim Mohammed

Doctor heba hamdy ibrahim

Cairo University

研究点 (1)

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