<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/NCT02982499</url>
  </required_header>
  <id_info>
    <org_study_id>20160376</org_study_id>
    <nct_id>NCT02982499</nct_id>
  </id_info>
  <brief_title>Biomechanics of Optic Neuropathy</brief_title>
  <official_title>Biomechanics of Optic Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The participant is being asked to be a subject in this research study because the participant&#xD;
      may have a disorder that can cause optic nerve damage and impairment of his/her visual&#xD;
      function which is called optic neuropathies (ON). Optic neuropathy refers to damage to the&#xD;
      optic nerve (a &quot;cable&quot; connecting the eyes and the brain to transmit the visual signals) due&#xD;
      to any cause.In this study, the investigator is using magnetic resonance imaging (MRI) and&#xD;
      ophthalmic measures such as optic coherent tomography(OCT), which are non-invasive imaging&#xD;
      tests to measure the changes in eye globe shape ,the flow of blood and brain fluid. It is&#xD;
      hoped that this study will provide new knowledge that may allow the investigator to better&#xD;
      understand the cause of symptoms associated with optic neuropathy and ways to better monitor&#xD;
      what is happening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal investigator's decision due to lack of resources&#xD;
  </why_stopped>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">March 26, 2018</completion_date>
  <primary_completion_date type="Actual">March 26, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Globe deformation</measure>
    <time_frame>day 1</time_frame>
    <description>Three measures of globe deformation are calculated by using the distance map: 1) optic nerve cupping(ONC), depicting the extent of the nerve head cupping; 2) posterior scleral bowing, depicting the degree of displacement of the posterior wall, and 3) maximal deformation (MD), depicting the combined deformation due to the displacement and the nerve cupping.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intracranial pressure</measure>
    <time_frame>Day 1</time_frame>
    <description>Intracranial pressure will be measured using non invasive MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal thickness</measure>
    <time_frame>Day 1</time_frame>
    <description>Corneal thickness will be measured by corneal pachymetry. After anesthetic numbing drop is placed on the eye, blunt probe will briefly touch the participant's eye to obtain the measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual field defect</measure>
    <time_frame>Day 1</time_frame>
    <description>Humphrey Field Analyzer II will be used to acquire the Mean deviation(MD).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Optic Neuropathy</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>Healthy participants will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>optic neuropathy group</arm_group_label>
    <description>Participants with optic neuropathy will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>magnetic resonance image (MRI)</intervention_name>
    <description>Radiographic imaging that takes about 30-45 minutes</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>optic neuropathy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical Coherence Tomography (OCT)</intervention_name>
    <description>Images taken from the back of the eye (retina)</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>optic neuropathy group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Case group: Patients with optic neuropathy who are 18 years or older Control group:&#xD;
        age-matched healthy subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria :&#xD;
&#xD;
          -  18 years old and on&#xD;
&#xD;
          -  Patients with optic neuropathy(10) and age controlled healthy subjects(10)&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  For patients: Subjects with history of neurological or ocular disease other than optic&#xD;
             neuropathy and refractory error.&#xD;
&#xD;
          -  For healthy control group: History of systemic disease except hypertension.&#xD;
&#xD;
          -  Pregnant women and prisoners will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byron R Lam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bascom Palmer Eye Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Byron Lam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>glaucoma</keyword>
  <keyword>Leber optic neuropathy</keyword>
  <keyword>anterior ischemic optic neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Optic Nerve Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02982499
org study id: 20160376
nct id: NCT02982499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The participant is being asked to be a subject in this research study because the participant
      may have a disorder that can cause optic nerve damage and impairment of his/her visual
      function which is called optic neuropathies (ON). Optic neuropathy refers to damage to the
      optic nerve (a "cable" connecting the eyes and the brain to transmit the visual signals) due
      to any cause.In this study, the investigator is using magnetic resonance imaging (MRI) and
      ophthalmic measures such as optic coherent tomography(OCT), which are non-invasive imaging
      tests to measure the changes in eye globe shape ,the flow of blood and brain fluid. It is
      hoped that this study will provide new knowledge that may allow the investigator to better
      understand the cause of symptoms associated with optic neuropathy and ways to better monitor
      what is happening.
observational model: Case-Control
time perspective: Prospective
measure: Globe deformation
time frame: day 1
description: Three measures of globe deformation are calculated by using the distance map: 1) optic nerve cupping(ONC), depicting the extent of the nerve head cupping; 2) posterior scleral bowing, depicting the degree of displacement of the posterior wall, and 3) maximal deformation (MD), depicting the combined deformation due to the displacement and the nerve cupping.
measure: intracranial pressure
time frame: Day 1
description: Intracranial pressure will be measured using non invasive MRI.
measure: Corneal thickness
time frame: Day 1
description: Corneal thickness will be measured by corneal pachymetry. After anesthetic numbing drop is placed on the eye, blunt probe will briefly touch the participant's eye to obtain the measurement.
measure: Visual field defect
time frame: Day 1
description: Humphrey Field Analyzer II will be used to acquire the Mean deviation(MD).
arm group label: control group
description: Healthy participants will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).
arm group label: optic neuropathy group
description: Participants with optic neuropathy will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).
intervention type: Device
intervention name: magnetic resonance image (MRI)
description: Radiographic imaging that takes about 30-45 minutes
arm group label: control group
arm group label: optic neuropathy group
intervention type: Device
intervention name: Optical Coherence Tomography (OCT)
description: Images taken from the back of the eye (retina)
arm group label: control group
arm group label: optic neuropathy group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Byron R Lam, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Byron Lam
investigator title: Professor
mesh term: Peripheral Nervous System Diseases
mesh term: Optic Nerve Diseases
sharing ipd: No