<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/NCT01680068</url>
  </required_header>
  <id_info>
    <org_study_id>2012815b</org_study_id>
    <nct_id>NCT01680068</nct_id>
  </id_info>
  <brief_title>Air Tamponade in Macular Hole Surgery</brief_title>
  <official_title>Air Tamponade in Macular Hole Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helse Stavanger HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Macular hole is a hole formation which takes place in the center of the retina. Such a hole&#xD;
      needs surgical steps in order to close. Closure of the macular hole will lead to a&#xD;
      substantially improvement of vision in most cases. Following macular hole surgery a tamponade&#xD;
      of intraocular gas is normally injected in order to keep the macula dry for the postoperative&#xD;
      period. Postoperative face down position for a week was earlier standard. Several authors&#xD;
      report of good closure rates with both air tamponade or lack of face down positioning. In&#xD;
      this study standard pars plana vitrectomy with peeling of the internal limiting membrane&#xD;
      (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down&#xD;
      positioning will not be used.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Closure rate of macular hole</measure>
    <time_frame>1 month after enrollment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Closure rate in macular holes larger than 400 micrometer</measure>
    <time_frame>1 month after enrollment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Visual gain after 6 months of follow up</measure>
    <time_frame>6 months after enrollment</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Macular Hole</condition>
  <arm_group>
    <arm_group_label>Pars plana vitrectomy and postoperative air tamponade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pars plana vitrectomy and postoperative air tamponade</intervention_name>
    <description>Pars plans vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.</description>
    <arm_group_label>Pars plana vitrectomy and postoperative air tamponade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic stage 2 - 4 macular hole&#xD;
&#xD;
          -  Duration of symptoms ≤ 36 months&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous vitreomacular surgery&#xD;
&#xD;
          -  Myopia ≥ 6 diopters&#xD;
&#xD;
          -  Ocular trauma&#xD;
&#xD;
          -  Disease affecting visual function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vegard Forsaa, MD</last_name>
    <role>Study Director</role>
    <affiliation>Helse Stavanger HF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stavanger University Hospital, Department of Ophthalmology</name>
      <address>
        <city>Stavanger</city>
        <zip>4016</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>December 4, 2013</last_update_submitted>
  <last_update_submitted_qc>December 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Macular hole</keyword>
  <keyword>Vitreoretinal surgery</keyword>
  <keyword>Macular surgery</keyword>
  <keyword>Air tamponade</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Perforations</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/NCT01680068
org study id: 2012815b
nct id: NCT01680068
lead sponsor: 
collaborator: 
has dmc: No
Macular hole is a hole formation which takes place in the center of the retina. Such a hole
      needs surgical steps in order to close. Closure of the macular hole will lead to a
      substantially improvement of vision in most cases. Following macular hole surgery a tamponade
      of intraocular gas is normally injected in order to keep the macula dry for the postoperative
      period. Postoperative face down position for a week was earlier standard. Several authors
      report of good closure rates with both air tamponade or lack of face down positioning. In
      this study standard pars plana vitrectomy with peeling of the internal limiting membrane
      (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down
      positioning will not be used.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Closure rate of macular hole
time frame: 1 month after enrollment
measure: Closure rate in macular holes larger than 400 micrometer
time frame: 1 month after enrollment
measure: Visual gain after 6 months of follow up
time frame: 6 months after enrollment
arm group label: Pars plana vitrectomy and postoperative air tamponade
arm group type: Experimental
description: Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
intervention type: Procedure
intervention name: Pars plana vitrectomy and postoperative air tamponade
description: Pars plans vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
arm group label: Pars plana vitrectomy and postoperative air tamponade
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Vegard Forsaa, MD
role: Study Director
affiliation: Helse Stavanger HF
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Retinal Perforations