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

NCT04431882 | Unknown Phase 2

• 1 other identifier: 0304628
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemic Patients With Increased Intracranial Pressure; Optic Nerve Sheath Fenestration

Outcome Measures

Primary Outcomes (2)

• Visual acuity using LOGMAR

  Visual acuity using LOGMAR

  Three months

• Papilledema grading using frisén scale

  Papilledema grading using frisén scale

  Three months

Secondary Outcomes (2)

• Visual acuity using LOGMAR

  2 weeks

• Papilledema grading using frisén scale

  2 weeks

Study Arms (1)

optic nerve sheath fenestration

EXPERIMENTAL

Leukemic patients mainly those suffering from acute lymphoblastic leukemia.

Procedure: optic nerve sheath fenestration

Interventions

optic nerve sheath fenestration PROCEDURE

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.

optic nerve sheath fenestration

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Can not get the informed consent

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

Location

Study Officials

• Mai ElBahwash

  Alexandria Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: June 1, 2019
• Primary Completion: June 10, 2020
• Study Completion: June 30, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)