<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/NCT01712555</url>
  </required_header>
  <id_info>
    <org_study_id>New York Eye and Ear Infirmary</org_study_id>
    <nct_id>NCT01712555</nct_id>
  </id_info>
  <brief_title>Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets</brief_title>
  <official_title>Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After people lose an eye, for whatever reason, they often experience fat atrophy of the&#xD;
      tissues in the orbit. This leads to a sunken appearance that is often not correctable by a&#xD;
      cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/&#xD;
      invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own&#xD;
      disadvantages. This study seeks to demonstrate an improvement in the retention of injected&#xD;
      autologous fat by mixing in autologous PRP (platelet rich plasma).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2011</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</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>Improved retention of autologous fat injected into anophthalmic sockets</measure>
    <time_frame>1-5 yrs</time_frame>
    <description>Non contrast MRIs of the orbits are obtained before, immediately after, and one year after injection of autologous fat mixed with autologous PRP (platelet rich plasma)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Orbital Atrophy</condition>
  <arm_group>
    <arm_group_label>fat grafting with PRP to anophthalmic orbits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There is only one arm to this study. People with orbital atrophy and loss of an eye are to be injected with autologous fat mixed with autologous PRP (platelet rich plasma) and observed for at least one year for evidence of retention of the injected fat</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>autologous fat grafting with PRP to anophthalmic orbits</intervention_name>
    <arm_group_label>fat grafting with PRP to anophthalmic orbits</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: anophthalmos, orbital atrophy -&#xD;
&#xD;
        Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>related info</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</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>
  <keyword>Anophthalmic orbits</keyword>
  <keyword>autologous fat</keyword>
  <keyword>platelet rich plasma</keyword>
  <keyword>orbital atrophy</keyword>
  <keyword>anophthalmos</keyword>
  <keyword>cannula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</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/NCT01712555
org study id: New York Eye and Ear Infirmary
nct id: NCT01712555
lead sponsor: 
has dmc: Yes
After people lose an eye, for whatever reason, they often experience fat atrophy of the
      tissues in the orbit. This leads to a sunken appearance that is often not correctable by a
      cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/
      invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own
      disadvantages. This study seeks to demonstrate an improvement in the retention of injected
      autologous fat by mixing in autologous PRP (platelet rich plasma).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improved retention of autologous fat injected into anophthalmic sockets
time frame: 1-5 yrs
description: Non contrast MRIs of the orbits are obtained before, immediately after, and one year after injection of autologous fat mixed with autologous PRP (platelet rich plasma)
arm group label: fat grafting with PRP to anophthalmic orbits
arm group type: Experimental
description: There is only one arm to this study. People with orbital atrophy and loss of an eye are to be injected with autologous fat mixed with autologous PRP (platelet rich plasma) and observed for at least one year for evidence of retention of the injected fat
intervention type: Procedure
intervention name: autologous fat grafting with PRP to anophthalmic orbits
arm group label: fat grafting with PRP to anophthalmic orbits
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://www.newyorkfami.com
description: related info
responsible party type: Sponsor
mesh term: Atrophy