<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/NCT03244007</url>
  </required_header>
  <id_info>
    <org_study_id>Kyorineye023</org_study_id>
    <nct_id>NCT03244007</nct_id>
  </id_info>
  <brief_title>Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy</brief_title>
  <official_title>Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyorin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyorin 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>
      We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with&#xD;
      idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings&#xD;
      will affect postoperative visual outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with&#xD;
      idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings&#xD;
      will affect postoperative visual outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2015</start_date>
  <completion_date type="Actual">June 11, 2017</completion_date>
  <primary_completion_date type="Actual">December 11, 2016</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>Recovery of microstructure</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual improvement</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Macular Disease</condition>
  <arm_group>
    <arm_group_label>Eyes with residual fragment</arm_group_label>
    <description>The eyes with residual fragments detected with intraoperative optical coherence tomography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eyes without residual fragment</arm_group_label>
    <description>The eyes without residual fragments detected with intraoperative optical coherence tomography</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vitrectomy</intervention_name>
    <arm_group_label>Eyes with residual fragment</arm_group_label>
    <arm_group_label>Eyes without residual fragment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The eyes with macular hole or lamellar macular hole&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Eyes with macular hole or lamellar macular hole -&#xD;
&#xD;
        Exclusion Criteria: Eyes with retinal detachment, retinal vascular disease, glaucoma&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Makoto Inoue, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korin Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Makoto Inoue</name>
      <address>
        <city>Mitaka-shi</city>
        <state>Tokyo</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyorin University</investigator_affiliation>
    <investigator_full_name>Makoto Inoue</investigator_full_name>
    <investigator_title>Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>macular hole</keyword>
  <keyword>lamellar macular hole</keyword>
  <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/NCT03244007
org study id: Kyorineye023
nct id: NCT03244007
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with
      idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings
      will affect postoperative visual outcome.
We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with
      idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings
      will affect postoperative visual outcome.
observational model: Case-Control
time perspective: Retrospective
measure: Recovery of microstructure
time frame: 6 months
measure: Visual improvement
time frame: 6 months
arm group label: Eyes with residual fragment
description: The eyes with residual fragments detected with intraoperative optical coherence tomography
arm group label: Eyes without residual fragment
description: The eyes without residual fragments detected with intraoperative optical coherence tomography
intervention type: Procedure
intervention name: Vitrectomy
arm group label: Eyes with residual fragment
arm group label: Eyes without residual fragment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Makoto Inoue, MD
role: Principal Investigator
affiliation: Korin Eye Center
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kyorin University
investigator full name: Makoto Inoue
investigator title: Professor of Ophthalmology
sharing ipd: No