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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Leukemic Patients With Increased Intracranial Pressure, Optic Nerve Sheath Fenestration

Intervention / Treatment
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* Procedure: optic nerve sheath fenestration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: optic nerve sheath fenestration<br>Leukemic patients mainly those suffering from acute lymphoblastic leukemia. | Procedure: optic nerve sheath fenestration<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity using LOGMAR | Visual acuity using LOGMAR | Three months | 
| Papilledema grading using frisén scale | Papilledema grading using frisén scale | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity using LOGMAR | Visual acuity using LOGMAR | 2 weeks | 
| Papilledema grading using frisén scale | Papilledema grading using frisén scale | 2 weeks |