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临床试验/NCT04431882
NCT04431882Unknown2 期

The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure

Alexandria University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
20
试验地点
1
主要终点
Visual acuity using LOGMAR

研究概览

简要总结

Optic nerve sheath fenestration (ONSF) first described by De Wecker in 1872 for the treatment of neuroretinitis. Since then, optic nerve sheath fenestration has become well established procedure for treatment of papilledema in medically uncontrolled patients of idiopathic intracranial hypertension.

详细描述

Optic nerve sheath fenestration (ONSF) first described by De Wecker in 1872 for the treatment of neuroretinitis. Since then optic nerve sheath fenestration has become well established procedure for treatment of papilledema in medically uncontrolled patients of idiopathic intracranial hypertension. Indications for ONSF in cancer patients are not well established, but a few case reports have shown success of ONSF in patients with perineural metastasis of breast cancer, increased intracranial pressure with papilledema due to a brain tumor, leukemia and optic nerve sheath meningioma. This study is conducted to establish the role of optic nerve sheath Fenestration in leukemic patients mainly those suffering from acute lymphoblastic leukemia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Evidence of progressive visual loss and papilledema did not improve despite the maximal medical therapy prescribed.
  • Informed written consent was obtained from the parents/care providers of the study participants.

排除标准

  • Can not get the informed consent

结局指标

主要结局

Visual acuity using LOGMAR

时间窗: Three months

Visual acuity using LOGMAR

Papilledema grading using frisén scale

时间窗: Three months

Papilledema grading using frisén scale

次要结局

  • Visual acuity using LOGMAR(2 weeks)
  • Papilledema grading using frisén scale(2 weeks)

研究者

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

Mohamed Fahmy Doheim

Dr.

Alexandria University

研究点 (1)

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