<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/NCT02244671</url>
  </required_header>
  <id_info>
    <org_study_id>13.27</org_study_id>
    <nct_id>NCT02244671</nct_id>
  </id_info>
  <brief_title>Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)</brief_title>
  <official_title>Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox, Donald Munro, M.D., P.C.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fox, Donald Munro, M.D., P.C.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with&#xD;
      platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immobilization of tissue (graft, graft bed) is a prerequisite for tissue integration. Since&#xD;
      yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat&#xD;
      injection into the anophthalmic orbit, the use of botulinum toxin(s) can be used to prevent&#xD;
      movement of the orbital tissue bed(s) and improve anchoring of injected fat. Platelet rich&#xD;
      plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process.&#xD;
      This innovation builds on the results of IRB protocols 10.27 and 12.01 as registered with&#xD;
      Clinical Trials.gov&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">January 3, 2018</completion_date>
  <primary_completion_date type="Actual">January 3, 2018</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>Orbital volume</measure>
    <time_frame>one year</time_frame>
    <description>Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Orbital Atrophy</condition>
  <arm_group>
    <arm_group_label>fat, PRP, botulinum toxin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fat, PRP, botulinum toxin</intervention_name>
    <description>fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin</description>
    <arm_group_label>fat, PRP, botulinum toxin</arm_group_label>
    <other_name>fat atrophy, absence of original eye, phthisis bulbi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>botulinum toxin</intervention_name>
    <description>botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.</description>
    <arm_group_label>fat, PRP, botulinum toxin</arm_group_label>
    <other_name>botulinum toxins</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PRP</intervention_name>
    <description>autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting</description>
    <arm_group_label>fat, PRP, botulinum toxin</arm_group_label>
    <other_name>platelet rich plasma</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  anophthalmic enophthalmos in subjects within a 50 mile radius of New York City, grade&#xD;
             0-1 anesthesia risk, ages 21-75&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  radiated orbits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donald M Fox, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Eye and Ear Infirmary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Eye and Ear Infirmary</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.newyorkfami.com</url>
    <description>fat grafting</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>August 16, 2018</last_update_submitted>
  <last_update_submitted_qc>August 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 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>Atrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 5, 2019</submitted>
    <returned>August 22, 2019</returned>
  </pending_results>
  <!-- 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/NCT02244671
org study id: 13.27
nct id: NCT02244671
lead sponsor: 
has dmc: No
immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with
      platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat
Immobilization of tissue (graft, graft bed) is a prerequisite for tissue integration. Since
      yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat
      injection into the anophthalmic orbit, the use of botulinum toxin(s) can be used to prevent
      movement of the orbital tissue bed(s) and improve anchoring of injected fat. Platelet rich
      plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process.
      This innovation builds on the results of IRB protocols 10.27 and 12.01 as registered with
      Clinical Trials.gov
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Orbital volume
time frame: one year
description: Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI
arm group label: fat, PRP, botulinum toxin
arm group type: Experimental
description: Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
intervention type: Procedure
intervention name: fat, PRP, botulinum toxin
description: fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
arm group label: fat, PRP, botulinum toxin
other name: fat atrophy, absence of original eye, phthisis bulbi
intervention type: Drug
intervention name: botulinum toxin
description: botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.
arm group label: fat, PRP, botulinum toxin
other name: botulinum toxins
intervention type: Device
intervention name: PRP
description: autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting
arm group label: fat, PRP, botulinum toxin
other name: platelet rich plasma
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Donald M Fox, MD
role: Principal Investigator
affiliation: New York Eye and Ear Infirmary
facility: 
country: United States
url: http://www.newyorkfami.com
description: fat grafting
responsible party type: Sponsor
mesh term: Atrophy
mesh term: Botulinum Toxins
submitted: August 5, 2019
returned: August 22, 2019