<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/NCT03304314</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-17-3754-YR-CTIL</org_study_id>
    <nct_id>NCT03304314</nct_id>
  </id_info>
  <brief_title>Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.</brief_title>
  <official_title>Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</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>
      PTC(Pseudotumor cerebri) patients may develop increased Intracranial pressure (ICP) that can&#xD;
      produces increased pressure around the distal optic nerve,which is likely followed by venule&#xD;
      compression, ischemia, and loss of visual function.Vision loss in PTC is most commonly&#xD;
      characterized by standard automated perimetry to measure peripheral visual field sensitivity.&#xD;
&#xD;
      Pupillometry is a promising approach for functional assessment in PTC because it is&#xD;
      noninvasive, objective, performed quickly with minimal patient cooperation needed.&#xD;
&#xD;
      The feasibility of using chromatic multifocal pupillometry for assesment of PTC will be&#xD;
      examined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 3, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus</measure>
    <time_frame>single visit: 1 day</time_frame>
    <description>Percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus</measure>
    <time_frame>single visit: 1 day</time_frame>
    <description>Pupil contraction and dilation velocity (in pixel/second) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus</measure>
    <time_frame>single visit: 1 day</time_frame>
    <description>Pupil contraction and dilation latency (in seconds) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective visual field</measure>
    <time_frame>single visit: 1 day</time_frame>
    <description>Humphrey perimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optic nerve structure by OCT</measure>
    <time_frame>single visit: 1 day</time_frame>
    <description>OCT imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours</measure>
    <time_frame>single visit: 1 day, 48 hours after baseline testing</time_frame>
    <description>The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours</measure>
    <time_frame>single visit: 1 day, 48 hours after baseline testing</time_frame>
    <description>The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours</measure>
    <time_frame>single visit: 1 day, 48 hours after baseline testing</time_frame>
    <description>The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week.</measure>
    <time_frame>single visit: 1 day, 1 week after baseline testing</time_frame>
    <description>The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 weeks after baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week.</measure>
    <time_frame>single visit: 1 day, 1 week after baseline testing</time_frame>
    <description>The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 week after baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation latency in PCT patients at 1 week.</measure>
    <time_frame>single visit: 1 day, 1 week after baseline testing</time_frame>
    <description>The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 week after baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months.</measure>
    <time_frame>single visit: 1 day, 2 months after baseline testing</time_frame>
    <description>The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months.</measure>
    <time_frame>single visit: 1 day, 2 months after baseline testing</time_frame>
    <description>The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pupil contraction and dilation latency in PCT patients at 2 months.</measure>
    <time_frame>single visit: 1 day, 2 months after baseline testing</time_frame>
    <description>The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pseudotumor Cerebri</condition>
  <arm_group>
    <arm_group_label>Pseudotumor cerebri (PTC) patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>objective chromatic multifocal pupillometer</intervention_name>
    <description>objective chromatic multifocal pupillometer (OCMP) enables objective and accurate measurement of pupillary responses to chromatic light at different wavelengths and light intensities and at different visual field locations.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Pseudotumor cerebri (PTC) patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy subjects&#xD;
&#xD;
          1. Male or female patients, age between 18 and 80 years, inclusive&#xD;
&#xD;
          2. Informed written consent will be obtained from all participants.&#xD;
&#xD;
          3. Normal eye examination&#xD;
&#xD;
          4. Best-corrected visual acuity (BCVA) of 20/20&#xD;
&#xD;
          5. Normal color vision test (Ishihara/HRR)&#xD;
&#xD;
          6. Normal Spectral-Domain Optical Coherence Tomography (SD-OCT)&#xD;
&#xD;
          7. Normal 24-2 Humphrey visual field (SITA Standard) and:&#xD;
&#xD;
               -  Short duration (≤10 minutes)&#xD;
&#xD;
               -  Minimal fixation losses, False POS errors and False NEG errors (less than 33% for&#xD;
                  each one of reliability indices)&#xD;
&#xD;
        PTC patients&#xD;
&#xD;
          1. Male or female patients, age between 18 and 80 years, inclusive&#xD;
&#xD;
          2. Best-corrected visual acuity (BCVA) of at least 20/100 in worse eye&#xD;
&#xD;
          3. Optic disc edema&#xD;
&#xD;
          4. PTC diagnosis based on Modified Dandy Criteria ( lumbar puncture with opening pressure&#xD;
             higher than or equal to 25 cm H2O, normal cerebrospinal fluid constituents, and&#xD;
             unremarkable brain imaging results except typical for PTC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Healthy subjects&#xD;
&#xD;
          1. History of past (last 3 months) or present ocular disease or ocular surgery&#xD;
&#xD;
          2. Use of any topical or systemic medications that could adversely influence pupillary&#xD;
             reflex&#xD;
&#xD;
          3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or&#xD;
             other schedule study procedure.&#xD;
&#xD;
          4. Mental impairment or instability such as that informed consent may not be obtained or&#xD;
             compliance with tester instructions is unlikely.&#xD;
&#xD;
          5. Visual media opacity including cloudy corneas.&#xD;
&#xD;
          6. Any condition preventing accurate measurement or examination of the pupil.&#xD;
&#xD;
        PTC patients&#xD;
&#xD;
          1. Any other neurologic or ophthalmic disease other than PTC&#xD;
&#xD;
          2. Use of any topical or systemic medications that could adversely influence pupillary&#xD;
             reflex&#xD;
&#xD;
          3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or&#xD;
             other schedule study procedure.&#xD;
&#xD;
          4. Mental impairment or instability such as that informed consent may not be obtained or&#xD;
             compliance with tester instructions is unlikely.&#xD;
&#xD;
          5. Visual media opacity including cloudy corneas.&#xD;
&#xD;
          6. Any condition preventing accurate measurement or examination of the pupil.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ygal Rotenstreich, MD</last_name>
    <phone>972-35302880</phone>
    <email>ygal.rotenstreich@sheba.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ifat Sher, PhD</last_name>
    <email>ifat.sherrosenthal@sheba.health.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel HaShomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruth Huna-Baron, MD</last_name>
      <phone>97235302536</phone>
      <email>Ruth.Huna-Baron@sheba.health.gov.il</email>
    </contact>
    <contact_backup>
      <last_name>Lori Gueta</last_name>
      <phone>972527485888</phone>
      <email>Lori.Gueta@sheba.health.gov.il</email>
    </contact_backup>
    <investigator>
      <last_name>Ruth Huna-Baron, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>January 15, 2023</last_update_submitted>
  <last_update_submitted_qc>January 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Ygal Rotenstreich</investigator_full_name>
    <investigator_title>Head of ElectrophisiologyClinic and Retinal Research Laboratory</investigator_title>
  </responsible_party>
  <keyword>PTC</keyword>
  <keyword>EYES</keyword>
  <keyword>Pseudotumor cerebri</keyword>
  <keyword>increased Intracranial pressure</keyword>
  <keyword>ICP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pseudotumor Cerebri</mesh_term>
  </condition_browse>
  <!-- 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/NCT03304314
org study id: SHEBA-17-3754-YR-CTIL
nct id: NCT03304314
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
PTC(Pseudotumor cerebri) patients may develop increased Intracranial pressure (ICP) that can
      produces increased pressure around the distal optic nerve,which is likely followed by venule
      compression, ischemia, and loss of visual function.Vision loss in PTC is most commonly
      characterized by standard automated perimetry to measure peripheral visual field sensitivity.

      Pupillometry is a promising approach for functional assessment in PTC because it is
      noninvasive, objective, performed quickly with minimal patient cooperation needed.

      The feasibility of using chromatic multifocal pupillometry for assesment of PTC will be
      examined.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus
time frame: single visit: 1 day
description: Percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls
measure: Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus
time frame: single visit: 1 day
description: Pupil contraction and dilation velocity (in pixel/second) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls
measure: Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus
time frame: single visit: 1 day
description: Pupil contraction and dilation latency (in seconds) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls
measure: Subjective visual field
time frame: single visit: 1 day
description: Humphrey perimetry
measure: Optic nerve structure by OCT
time frame: single visit: 1 day
description: OCT imaging
measure: Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours
time frame: single visit: 1 day, 48 hours after baseline testing
description: The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement
measure: Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours
time frame: single visit: 1 day, 48 hours after baseline testing
description: The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement
measure: Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours
time frame: single visit: 1 day, 48 hours after baseline testing
description: The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement
measure: Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week.
time frame: single visit: 1 day, 1 week after baseline testing
description: The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 weeks after baseline measurement
measure: Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week.
time frame: single visit: 1 day, 1 week after baseline testing
description: The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 week after baseline measurement
measure: Change from baseline pupil contraction and dilation latency in PCT patients at 1 week.
time frame: single visit: 1 day, 1 week after baseline testing
description: The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 week after baseline measurement
measure: Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months.
time frame: single visit: 1 day, 2 months after baseline testing
description: The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement
measure: Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months.
time frame: single visit: 1 day, 2 months after baseline testing
description: The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement
measure: Change from baseline pupil contraction and dilation latency in PCT patients at 2 months.
time frame: single visit: 1 day, 2 months after baseline testing
description: The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement
arm group label: Pseudotumor cerebri (PTC) patients
arm group type: Experimental
arm group label: Control
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: objective chromatic multifocal pupillometer
description: objective chromatic multifocal pupillometer (OCMP) enables objective and accurate measurement of pupillary responses to chromatic light at different wavelengths and light intensities and at different visual field locations.
arm group label: Control
arm group label: Pseudotumor cerebri (PTC) patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ygal Rotenstreich, MD
phone: 972-35302880
email: ygal.rotenstreich@sheba.health.gov.il
last name: Ifat Sher, PhD
email: ifat.sherrosenthal@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Ygal Rotenstreich
investigator title: Head of ElectrophisiologyClinic and Retinal Research Laboratory
mesh term: Pseudotumor Cerebri