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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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04431882
Enrollment
20
Registered
2020-06-16
Start date
2019-06-01
Completion date
2020-06-30
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemic Patients With Increased Intracranial Pressure, Optic Nerve Sheath Fenestration

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.

Interventions

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.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity using LOGMARThree monthsVisual acuity using LOGMAR
Papilledema grading using frisén scaleThree monthsPapilledema grading using frisén scale

Secondary

MeasureTime frameDescription
Visual acuity using LOGMAR2 weeksVisual acuity using LOGMAR
Papilledema grading using frisén scale2 weeksPapilledema grading using frisén scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026