<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/NCT03260049</url>
  </required_header>
  <id_info>
    <org_study_id>ChongqingMU-2</org_study_id>
    <nct_id>NCT03260049</nct_id>
  </id_info>
  <brief_title>The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients</brief_title>
  <official_title>The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chongqing Medical 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>
      The records of patients who were diagnosed with ARN between April 2010 and February 2017 were&#xD;
      analyzed.A retrospective review of the treatment options and outcomes of the these patients&#xD;
      was performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>visual acuity</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>retinal detachement</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Acute Retinal Necrosis</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>there was no retinal detachment (RD) at the first visit. The group 1 patients were treated with systemic antiviral medications, as well as with intravitreal antiviral injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>there was no RD at the first visit. The group 2 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <description>there was RD at the first visit. The group 3 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pars plana vitrectomy</intervention_name>
    <description>pars plana vitrectomy</description>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3</arm_group_label>
    <other_name>systemic antiviral medications</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        ARN patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ARN was diagnosed according to the American Uveitis Society Diagnostic Criteria (1994)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Shulin Liu</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Necrosis Syndrome, Acute</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antiviral Agents</mesh_term>
  </intervention_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/NCT03260049
org study id: ChongqingMU-2
nct id: NCT03260049
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The records of patients who were diagnosed with ARN between April 2010 and February 2017 were
      analyzed.A retrospective review of the treatment options and outcomes of the these patients
      was performed.
observational model: Case-Only
time perspective: Retrospective
measure: visual acuity
time frame: 1 year
measure: retinal detachement
time frame: 1 year
arm group label: 1
description: there was no retinal detachment (RD) at the first visit. The group 1 patients were treated with systemic antiviral medications, as well as with intravitreal antiviral injections
arm group label: 2
description: there was no RD at the first visit. The group 2 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection.
arm group label: 3
description: there was RD at the first visit. The group 3 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection
intervention type: Procedure
intervention name: pars plana vitrectomy
description: pars plana vitrectomy
arm group label: 2
arm group label: 3
other name: systemic antiviral medications
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Chongqing Medical University
investigator full name: Shulin Liu
investigator title: Dr.
mesh term: Retinal Necrosis Syndrome, Acute
mesh term: Necrosis
mesh term: Antiviral Agents
sharing ipd: No