<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04431882</url>
  </required_header>
  <id_info>
    <org_study_id>0304628</org_study_id>
    <nct_id>NCT04431882</nct_id>
  </id_info>
  <brief_title>The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure</brief_title>
  <official_title>The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optic nerve sheath fenestration (ONSF) first described by De Wecker in 1872 for the treatment&#xD;
      of neuroretinitis. Since then, optic nerve sheath fenestration has become well established&#xD;
      procedure for treatment of papilledema in medically uncontrolled patients of idiopathic&#xD;
      intracranial hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Optic nerve sheath fenestration (ONSF) first described by De Wecker in 1872 for the treatment&#xD;
      of neuroretinitis. Since then optic nerve sheath fenestration has become well established&#xD;
      procedure for treatment of papilledema in medically uncontrolled patients of idiopathic&#xD;
      intracranial hypertension. Indications for ONSF in cancer patients are not well established,&#xD;
      but a few case reports have shown success of ONSF in patients with perineural metastasis of&#xD;
      breast cancer, increased intracranial pressure with papilledema due to a brain tumor,&#xD;
      leukemia and optic nerve sheath meningioma. This study is conducted to establish the role of&#xD;
      optic nerve sheath Fenestration in leukemic patients mainly those suffering from acute&#xD;
      lymphoblastic leukemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 10, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity using LOGMAR</measure>
    <time_frame>Three months</time_frame>
    <description>Visual acuity using LOGMAR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Papilledema grading using frisén scale</measure>
    <time_frame>Three months</time_frame>
    <description>Papilledema grading using frisén scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity using LOGMAR</measure>
    <time_frame>2 weeks</time_frame>
    <description>Visual acuity using LOGMAR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Papilledema grading using frisén scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Papilledema grading using frisén scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Leukemic Patients With Increased Intracranial Pressure</condition>
  <condition>Optic Nerve Sheath Fenestration</condition>
  <arm_group>
    <arm_group_label>optic nerve sheath fenestration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Leukemic patients mainly those suffering from acute lymphoblastic leukemia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>optic nerve sheath fenestration</intervention_name>
    <description>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.</description>
    <arm_group_label>optic nerve sheath fenestration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of progressive visual loss and papilledema did not improve despite the&#xD;
             maximal medical therapy prescribed.&#xD;
&#xD;
          -  Informed written consent was obtained from the parents/care providers of the study&#xD;
             participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Can not get the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mai ElBahwash</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Mohamed Fahmy Doheim</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data shared upon request from the corresponding author</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04431882
org study id: 0304628
nct id: NCT04431882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Visual acuity using LOGMAR
time frame: Three months
description: Visual acuity using LOGMAR
measure: Papilledema grading using frisén scale
time frame: Three months
description: Papilledema grading using frisén scale
measure: Visual acuity using LOGMAR
time frame: 2 weeks
description: Visual acuity using LOGMAR
measure: Papilledema grading using frisén scale
time frame: 2 weeks
description: Papilledema grading using frisén scale
arm group label: optic nerve sheath fenestration
arm group type: Experimental
description: Leukemic patients mainly those suffering from acute lymphoblastic leukemia.
intervention type: Procedure
intervention name: optic nerve sheath fenestration
description: 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.
arm group label: optic nerve sheath fenestration
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Mai ElBahwash
role: Principal Investigator
affiliation: Alexandria Faculty of Medicine
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Mohamed Fahmy Doheim
investigator title: Dr.
mesh term: Intracranial Hypertension
sharing ipd: No
ipd description: Individual participant data shared upon request from the corresponding author