<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/NCT02205632</url>
  </required_header>
  <id_info>
    <org_study_id>MPSII-RMB</org_study_id>
    <nct_id>NCT02205632</nct_id>
  </id_info>
  <brief_title>Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <brief_summary>
    <textblock>
      Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the&#xD;
      macular area.&#xD;
&#xD;
      Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be&#xD;
      evaluated by its optical density.&#xD;
&#xD;
      Reduced macular pigment level is a significant risk factor for age-macular degeneration. The&#xD;
      nutritional intake can minimise the risk of age-macular degeneration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Association between lacquer cracks related to high myopia and the macular pigment optical density</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The macular pigment optical density among high myopic patients</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>High Myopia</condition>
  <arm_group>
    <arm_group_label>High myopic patients with lacker craks</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High myopic patients without lacker cracks</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MPS II</intervention_name>
    <arm_group_label>High myopic patients with lacker craks</arm_group_label>
    <arm_group_label>High myopic patients without lacker cracks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years-old&#xD;
&#xD;
          -  High axial myopia &lt; -6 dioptries&#xD;
&#xD;
          -  Presence or not of lacquer cracks in Bruch's membrane in one or both eyes&#xD;
&#xD;
          -  Patients with social security coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years-old&#xD;
&#xD;
          -  Amblyopia in the studied eye&#xD;
&#xD;
          -  Prior ocular surgery&#xD;
&#xD;
          -  Corneal disease or severe dry eye syndrome&#xD;
&#xD;
          -  Other retinal disease: diabetic retinopathy, age-related macular degeneration, macular&#xD;
             hole, epiretinal membrane central&#xD;
&#xD;
          -  Extensive chorioretinal atrophy&#xD;
&#xD;
          -  Allergy to tropicamide&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas LEVEZIEL, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Poitiers University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ophthalmology department, Poitiers University Hospital</name>
      <address>
        <city>Poitiers</city>
        <state>Vienne</state>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</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/NCT02205632
org study id: MPSII-RMB
nct id: NCT02205632
lead sponsor: 
Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the
      macular area.

      Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be
      evaluated by its optical density.

      Reduced macular pigment level is a significant risk factor for age-macular degeneration. The
      nutritional intake can minimise the risk of age-macular degeneration.
allocation: Non-Randomized
masking: None (Open Label)
measure: Association between lacquer cracks related to high myopia and the macular pigment optical density
time frame: 1 day
measure: The macular pigment optical density among high myopic patients
time frame: 1 day
arm group label: High myopic patients with lacker craks
arm group type: Other
arm group label: High myopic patients without lacker cracks
arm group type: Other
intervention type: Device
intervention name: MPS II
arm group label: High myopic patients with lacker craks
arm group label: High myopic patients without lacker cracks
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas LEVEZIEL, MD, PhD
role: Principal Investigator
affiliation: Poitiers University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Myopia