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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431882
Recruitment Status : Active, not recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Fahmy Doheim, 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.

Condition or disease Intervention/treatment Phase
Leukemic Patients With Increased Intracranial Pressure Optic Nerve Sheath Fenestration Procedure: optic nerve sheath fenestration Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : June 10, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: optic nerve sheath fenestration
Leukemic patients mainly those suffering from acute lymphoblastic leukemia.
Procedure: optic nerve sheath fenestration
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 Measures :
  1. Visual acuity using LOGMAR [ Time Frame: Three months ]
    Visual acuity using LOGMAR

  2. Papilledema grading using frisén scale [ Time Frame: Three months ]
    Papilledema grading using frisén scale


Secondary Outcome Measures :
  1. Visual acuity using LOGMAR [ Time Frame: 2 weeks ]
    Visual acuity using LOGMAR

  2. Papilledema grading using frisén scale [ Time Frame: 2 weeks ]
    Papilledema grading using frisén scale



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431882


Locations
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Egypt
Alexandria Faculty of Medicine
Alexandria, Egypt
Sponsors and Collaborators
Alexandria University
Investigators
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Principal Investigator: Mai ElBahwash Alexandria Faculty of Medicine
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Responsible Party: Mohamed Fahmy Doheim, Dr., Alexandria University
ClinicalTrials.gov Identifier: NCT04431882    
Other Study ID Numbers: 0304628
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data shared upon request from the corresponding author

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases