<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/NCT02988583</url>
  </required_header>
  <id_info>
    <org_study_id>HE591018</org_study_id>
    <nct_id>NCT02988583</nct_id>
  </id_info>
  <brief_title>Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery</brief_title>
  <official_title>Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khon Kaen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Silicone oil has been used as a surgical tool in complicated retinal detachment surgery.&#xD;
      There are some complications occurring in pars plana vitrectomy with silicone oil tamponade.&#xD;
      Silicone oil emulsification is one of the complication that may result in severe sequels that&#xD;
      are difficult to treat. It is believed that low viscosity silicone oil has more risk to&#xD;
      develop emulsification than high viscosity silicone oil. Up to now, however, there is no&#xD;
      conclusive guideline that which types of silicone oil is suitable for these complicated&#xD;
      retinal detachment surgeries and what is the appropriate time to remove the oil. This&#xD;
      prospective study aims to study the silicone oil emulsification comparing between low&#xD;
      viscosity and high viscosity silicone oil after complicated retinal detachment surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Silicone oil has been used as a surgical tool in retinal detachment surgery since 1962. The&#xD;
      National Eye Institute Silicone Study demonstrated the superiority of silicone oil compared&#xD;
      with sulfur hexafluoride, and its comparability with perfluoropropane, for the treatment of&#xD;
      complicated retinal detachment associated with advanced proliferative vitreoretinopathy.&#xD;
      There are some complications occurring in pars plana vitrectomy with silicone oil tamponade.&#xD;
      These complications may occur during surgery and after the surgery. Silicone oil&#xD;
      emulsification is one of the complication that may result in severe sequels including&#xD;
      band-shaped keratopathy, complicated glaucoma and retinopathy that are difficult to treat.&#xD;
      The commonly used silicone oil includes low viscosity and high viscosity type. It is believed&#xD;
      that low viscosity silicone oil has more risk to develop emulsification than high viscosity&#xD;
      silicone oil. Up to now, however, there is no conclusive guideline that which types of&#xD;
      silicone oil is suitable for these complicated retinal detachment surgeries and what is the&#xD;
      appropriate time to remove the oil. Retrospective medical review of these patients using&#xD;
      1000-vs 5000-centistoke silicone oil demonstrated that anatomic and visual acuity outcomes,&#xD;
      as well as complication rates including emulsification, were similar in both groups. To the&#xD;
      best of authors' knowledge, there has been no prospective study on this subject. This study&#xD;
      aims to study the silicone oil emulsification comparing between low viscosity and high&#xD;
      viscosity silicone oil after complicated retinal detachment surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emulsification rate</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of patients developing silicone oil emulsification in each arm/group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retina reattachment rate</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of patients having retinal reattachment after surgery in each arm/group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual improvement</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of patients having visual improvement after surgery in each arm/group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Retinal Detachment Rhegmatogenous</condition>
  <arm_group>
    <arm_group_label>low viscosity silicone oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Retinal detachment surgery using low viscosity silicone oil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high viscosity silicone oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Retinal detachment surgery using high viscosity silicone oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgery using low viscosity silicone oil</intervention_name>
    <description>Pars plans vitrectomy using low viscosity silicone oil</description>
    <arm_group_label>low viscosity silicone oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgery using high viscosity silicone oil</intervention_name>
    <description>Pars plans vitrectomy using high viscosity silicone oil</description>
    <arm_group_label>high viscosity silicone oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of complicated retinal detachment who underwent pars plana&#xD;
             vitrectomy with intravitreal silicone oil tamponade&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Sign informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory eye diseases i.e. uveitis&#xD;
&#xD;
          -  Corneal scar&#xD;
&#xD;
          -  History of scleral buckling procedure&#xD;
&#xD;
          -  History of using surfactant drugs&#xD;
&#xD;
          -  Glaucoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Srinagarind Hospital, Khon Kaen University</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Yosanan Yospaiboon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>silicone oil</keyword>
  <keyword>emulsification</keyword>
  <keyword>retinal detachment surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Dissociative Disorders</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/NCT02988583
org study id: HE591018
nct id: NCT02988583
lead sponsor: 
has dmc: No
Silicone oil has been used as a surgical tool in complicated retinal detachment surgery.
      There are some complications occurring in pars plana vitrectomy with silicone oil tamponade.
      Silicone oil emulsification is one of the complication that may result in severe sequels that
      are difficult to treat. It is believed that low viscosity silicone oil has more risk to
      develop emulsification than high viscosity silicone oil. Up to now, however, there is no
      conclusive guideline that which types of silicone oil is suitable for these complicated
      retinal detachment surgeries and what is the appropriate time to remove the oil. This
      prospective study aims to study the silicone oil emulsification comparing between low
      viscosity and high viscosity silicone oil after complicated retinal detachment surgery.
Silicone oil has been used as a surgical tool in retinal detachment surgery since 1962. The
      National Eye Institute Silicone Study demonstrated the superiority of silicone oil compared
      with sulfur hexafluoride, and its comparability with perfluoropropane, for the treatment of
      complicated retinal detachment associated with advanced proliferative vitreoretinopathy.
      There are some complications occurring in pars plana vitrectomy with silicone oil tamponade.
      These complications may occur during surgery and after the surgery. Silicone oil
      emulsification is one of the complication that may result in severe sequels including
      band-shaped keratopathy, complicated glaucoma and retinopathy that are difficult to treat.
      The commonly used silicone oil includes low viscosity and high viscosity type. It is believed
      that low viscosity silicone oil has more risk to develop emulsification than high viscosity
      silicone oil. Up to now, however, there is no conclusive guideline that which types of
      silicone oil is suitable for these complicated retinal detachment surgeries and what is the
      appropriate time to remove the oil. Retrospective medical review of these patients using
      1000-vs 5000-centistoke silicone oil demonstrated that anatomic and visual acuity outcomes,
      as well as complication rates including emulsification, were similar in both groups. To the
      best of authors' knowledge, there has been no prospective study on this subject. This study
      aims to study the silicone oil emulsification comparing between low viscosity and high
      viscosity silicone oil after complicated retinal detachment surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Emulsification rate
time frame: 12 months
description: Proportion of patients developing silicone oil emulsification in each arm/group.
measure: Retina reattachment rate
time frame: 12 months
description: Proportion of patients having retinal reattachment after surgery in each arm/group.
measure: visual improvement
time frame: 12 months
description: Proportion of patients having visual improvement after surgery in each arm/group
arm group label: low viscosity silicone oil
arm group type: Experimental
description: Retinal detachment surgery using low viscosity silicone oil
arm group label: high viscosity silicone oil
arm group type: Active Comparator
description: Retinal detachment surgery using high viscosity silicone oil
intervention type: Device
intervention name: Surgery using low viscosity silicone oil
description: Pars plans vitrectomy using low viscosity silicone oil
arm group label: low viscosity silicone oil
intervention type: Device
intervention name: Surgery using high viscosity silicone oil
description: Pars plans vitrectomy using high viscosity silicone oil
arm group label: high viscosity silicone oil
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Yosanan Yospaiboon
investigator title: Professor
mesh term: Retinal Detachment
mesh term: Dissociative Disorders
sharing ipd: No