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临床试验/NCT04537169
NCT04537169Unknown不适用

Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis

Menoufia University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年8月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
1
主要终点
Success of levator resection in relation to structure of Whitnall ligament

研究概览

简要总结

Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.

详细描述

The study will be a prospective obsevational study. It will include patients (2-16 years old) who will undergo levator resection for simple congenital ptosis correction in Ophthalmology Department of Menoufia University Hospital.

Patients will be divided into 3 groups, 15 patients in each. Group I for mild ptosis, Group II for moderate ptosis Group 3 for severe ptosis.

Exclusion criteria included any patients with previous ptosis or any eyelid surgery and patients with a non congenital ptosis.

Patients included in the study well be informed about the research and the surgical maneuver which will be used with full discussion of all details regarding the postoperative follow up and the potential complications. A written consent in Arabic will then be taken from the parents of the patients

Preoperative assessment will include Complete ophthalmological examination including; Margin to Reflex Distance 1 (MRD1), Vertical Fissure Height (VFH), Levator function (LF), and eyelid crease shape and position.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Congenital ptosis

排除标准

  • Previous ptosis surgery
  • Non congenital ptosis

结局指标

主要结局

Success of levator resection in relation to structure of Whitnall ligament

时间窗: An average of 1 year

Relating the structure of the ligament with the degree of severity of ptosis by studying its position, shape and tightness in all cases during surgery

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

Sameh S. Mandour

Assistant Professor of Ophthalmology

Menoufia University

研究点 (1)

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