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

Optic Nerve Sheath Fenestration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04431882
• Other study ID #: 0304628
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Hypertension
• Leukemic Patients With Increased Intracranial Pressure
• Optic Nerve Sheath Fenestration

Intervention

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.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity using LOGMAR	Visual acuity using LOGMAR	Three months
Primary	Papilledema grading using frisén scale	Papilledema grading using frisén scale	Three months
Secondary	Visual acuity using LOGMAR	Visual acuity using LOGMAR	2 weeks
Secondary	Papilledema grading using frisén scale	Papilledema grading using frisén scale	2 weeks