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

Phase 2

• Conditions: Optic Nerve Sheath Fenestration; Leukemic Patients With Increased Intracranial Pressure
• Interventions: Procedure: optic nerve sheath fenestration

• Registration Number: NCT04431882
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2020-06
• Primary Completion: 2020-06-10
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-11
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• Can not get the informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
optic nerve sheath fenestration	optic nerve sheath fenestration	Leukemic patients mainly those suffering from acute lymphoblastic leukemia.

Primary Outcome Measures

Name	Time	Method
Visual acuity using LOGMAR	Three months	Visual acuity using LOGMAR
Papilledema grading using frisén scale	Three months	Papilledema grading using frisén scale

Secondary Outcome Measures

Name	Time	Method
Visual acuity using LOGMAR	2 weeks	Visual acuity using LOGMAR
Papilledema grading using frisén scale	2 weeks	Papilledema grading using frisén scale

Trial Locations

Locations (1)

Alexandria Faculty of Medicine; 🇪🇬 Alexandria, Egypt