<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/NCT02196532</url>
  </required_header>
  <id_info>
    <org_study_id>FYF20140717</org_study_id>
    <nct_id>NCT02196532</nct_id>
  </id_info>
  <brief_title>Retinal Nerve Fiber Layer Thickness Changes in Migraine: A Meta-Analysis of Case-control Studies</brief_title>
  <official_title>Retinal Nerve Fiber Layer Thickness Changes in Migraine: A Meta-Analysis of Case-control Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yifan Feng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can&#xD;
      provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer&#xD;
      (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in&#xD;
      several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's&#xD;
      disease. Different studies have reported RNFL changes also in migraine, is a common&#xD;
      hereditary chronic neurovascular disorder, characterized by dysfunction of the autonomic&#xD;
      nervous system. The pathophysiology of migraine has not been fully clarified, but there is&#xD;
      increasing evidence that episodes of migraine with aura are initiated by a focal reduction in&#xD;
      cerebral blood flow, which occurs most commonly in the posterior region of one hemisphere.&#xD;
      Although vasoconstriction of cerebral and retinal blood vessels is a transient phenomenon,&#xD;
      the chronic nature of the migraine might cause permanent structural abnormalities of the&#xD;
      brain and also of the retina, which may correlate with RNFL thinning. Previous studies on&#xD;
      this subject, however, reported contradicting results. Some investigations reported&#xD;
      reductions of the RNFL thickness while others did not. In the present study, in order to&#xD;
      determine whether RNFL thickness is reduced in migraine patients, the investigators performed&#xD;
      a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series&#xD;
      of migraine patients and in the healthy control groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal Nerve Fiber Layer Thickness</measure>
    <time_frame>Baseline</time_frame>
    <description>Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°)was measured by OCT.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>migraine group</arm_group_label>
    <description>Patients with migraine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy control</arm_group_label>
    <description>Sex- and agematched healthy subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Device: Optical coherence tomography</intervention_name>
    <arm_group_label>healthy control</arm_group_label>
    <arm_group_label>migraine group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Migraine patients and healthy subjects were included and underwent OCT examinations&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. case-control studies;&#xD;
&#xD;
          2. patients with Migraine were compared with healthy controls;&#xD;
&#xD;
          3. all subjects underwent RNFL thickness measurement by OCT;&#xD;
&#xD;
          4. studies should provide the data of peripapillary RNFL thickness;&#xD;
&#xD;
          5. sample size ≥10 in each group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. authors did not make RNFL measurements;&#xD;
&#xD;
          2. study without healthy control group;&#xD;
&#xD;
          3. the outcome values can not be used for meta-analysis;&#xD;
&#xD;
          4. duplicated articles.&#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_official>
    <last_name>Yifan Feng, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yifan Feng, PhD</last_name>
    <phone>862164041990</phone>
    <email>wzafengyifan@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yifan Feng, PhD</last_name>
      <phone>862164041990</phone>
      <email>wzafengyifan@163.com</email>
    </contact>
    <investigator>
      <last_name>Yifan Feng, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Yifan Feng</investigator_full_name>
    <investigator_title>Zhongshan hospital, Fudan University</investigator_title>
  </responsible_party>
  <keyword>retinal nerve fiber layer thickness</keyword>
  <keyword>optical coherence tomography</keyword>
  <keyword>migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</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/NCT02196532
org study id: FYF20140717
nct id: NCT02196532
lead sponsor: 
collaborator: 
has dmc: No
Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can
      provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer
      (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in
      several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's
      disease. Different studies have reported RNFL changes also in migraine, is a common
      hereditary chronic neurovascular disorder, characterized by dysfunction of the autonomic
      nervous system. The pathophysiology of migraine has not been fully clarified, but there is
      increasing evidence that episodes of migraine with aura are initiated by a focal reduction in
      cerebral blood flow, which occurs most commonly in the posterior region of one hemisphere.
      Although vasoconstriction of cerebral and retinal blood vessels is a transient phenomenon,
      the chronic nature of the migraine might cause permanent structural abnormalities of the
      brain and also of the retina, which may correlate with RNFL thinning. Previous studies on
      this subject, however, reported contradicting results. Some investigations reported
      reductions of the RNFL thickness while others did not. In the present study, in order to
      determine whether RNFL thickness is reduced in migraine patients, the investigators performed
      a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series
      of migraine patients and in the healthy control groups.
observational model: Case-Control
time perspective: Retrospective
measure: Retinal Nerve Fiber Layer Thickness
time frame: Baseline
description: Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°)was measured by OCT.
arm group label: migraine group
description: Patients with migraine
arm group label: healthy control
description: Sex- and agematched healthy subjects
intervention type: Device
intervention name: Device: Optical coherence tomography
arm group label: healthy control
arm group label: migraine group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yifan Feng, PhD
role: Principal Investigator
affiliation: Fudan University
last name: Yifan Feng, PhD
phone: 862164041990
email: wzafengyifan@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Yifan Feng
investigator title: Zhongshan hospital, Fudan University
mesh term: Migraine Disorders