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

Primary Purpose

Leukemic Patients With Increased Intracranial Pressure, Optic Nerve Sheath Fenestration

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
optic nerve sheath fenestration
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemic Patients With Increased Intracranial Pressure

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alexandria Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

optic nerve sheath fenestration

Arm Description

Leukemic patients mainly those suffering from acute lymphoblastic leukemia.

Outcomes

Primary Outcome Measures

Visual acuity using LOGMAR
Visual acuity using LOGMAR
Papilledema grading using frisén scale
Papilledema grading using frisén scale

Secondary Outcome Measures

Visual acuity using LOGMAR
Visual acuity using LOGMAR
Papilledema grading using frisén scale
Papilledema grading using frisén scale

Full Information

First Posted
June 11, 2020
Last Updated
June 11, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04431882
Brief Title
The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure
Official Title
The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 10, 2020 (Actual)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemic Patients With Increased Intracranial Pressure, Optic Nerve Sheath Fenestration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
optic nerve sheath fenestration
Arm Type
Experimental
Arm Description
Leukemic patients mainly those suffering from acute lymphoblastic leukemia.
Intervention Type
Procedure
Intervention Name(s)
optic nerve sheath fenestration
Intervention 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.
Primary Outcome Measure Information:
Title
Visual acuity using LOGMAR
Description
Visual acuity using LOGMAR
Time Frame
Three months
Title
Papilledema grading using frisén scale
Description
Papilledema grading using frisén scale
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Visual acuity using LOGMAR
Description
Visual acuity using LOGMAR
Time Frame
2 weeks
Title
Papilledema grading using frisén scale
Description
Papilledema grading using frisén scale
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai ElBahwash
Organizational Affiliation
Alexandria Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data shared upon request from the corresponding author

Learn more about this trial

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

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