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

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

Sponsors

Lead Sponsor: Alexandria University

Source 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.

Overall Status Active, not recruiting
Start Date 2019-06-01
Completion Date 2020-06-30
Primary Completion Date 2020-06-10
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual acuity using LOGMAR Three months
Papilledema grading using frisén scale Three months
Secondary Outcome
Measure Time Frame
Visual acuity using LOGMAR 2 weeks
Papilledema grading using frisén scale 2 weeks
Enrollment 20
Condition
Intervention

Intervention Type: Procedure

Intervention Name: optic nerve sheath fenestration

Description: A standard medial transconjunctival orbitotomy was performed in all cases under general anesthesia. The medial rectus muscle was disinserted and reflected nasally with 6-0 synthetic polyester suture in typical fashion for eye muscle surgery. A traction suture was then placed through the insertion stump of the medial rectus in a baseball stitch fashion to facilitate abduction of the globe. The pupil was monitored at all times. A custom- made cupped orbital retractor was inserted along the medial scleral wall and used to retract the orbital fat and allow visualization of the optic nerve sheath. Retraction and globe abduction were relaxed if any changes in pupil size were noted. When adequate visualization was achieved, multiple dural sheath fenestrations approximately 3 mm in length. Expulsion of cerebrospinal fluid was invariably observed with the initial incision into the dural sheath.

Arm Group Label: optic nerve sheath fenestration

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

6 Years

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Mai ElBahwash Principal Investigator Alexandria Faculty of Medicine
Location
Facility: Alexandria Faculty of Medicine
Location Countries

Egypt

Verification Date

2020-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Alexandria University

Investigator Full Name: Mohamed Fahmy Doheim

Investigator Title: Dr.

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: optic nerve sheath fenestration

Type: Experimental

Description: Leukemic patients mainly those suffering from acute lymphoblastic leukemia.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: A single arm clinical trial for patients presenting with severe sight threatening papilledema due increased intracranial pressure following leukemia treatment meeting the criteria of idiopathic intracranial hypertension not responding to maximal medical treatment.

Primary Purpose: Treatment

Masking: None (Open Label)

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