<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/NCT03819621</url>
  </required_header>
  <id_info>
    <org_study_id>SAGM1005</org_study_id>
    <nct_id>NCT03819621</nct_id>
  </id_info>
  <brief_title>Digital Imaging Assessment of Ocular Prosthesis Motility</brief_title>
  <acronym>OCUPEYE</acronym>
  <official_title>Objective Assessment of Orbital Implant and Ocular Prosthesis Motility Using a Digital Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moorfields Eye Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Moorfields Eye Hospital NHS Foundation Trust</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>
      This study will evaluate the degree of translational movement loss from orbital implant to&#xD;
      ocular prosthesis. This will be measured using two software applications - Image J as well as&#xD;
      the mediGrid smartphone app in measuring prosthesis motility by comparing it to the ruler as&#xD;
      a &quot;gold&quot; standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The fit and function of an ocular prosthetic determines the effective motility (movement)&#xD;
      within the patient's eye socket. A poor fitting ocular prosthesis will lead to poor motility,&#xD;
      patient discomfort and increased mucus discharge, and can risk the integrity of the anterior&#xD;
      surface of the implanted orbit. Currently the method to determine best fit of the ocular&#xD;
      prosthesis is dependent upon the ocularist's skill in adding or subtracting material from the&#xD;
      wax model that is replicated from an initial alginate impression of the patient's eye socket.&#xD;
&#xD;
      The proposal of this study is to utilise digital imaging to capture images to measure the&#xD;
      motility of both the orbital implant and the ocular prosthesis. Two methods will be compared:&#xD;
      excursion measurements on a photograph using digital software (Image J) versus use of a smart&#xD;
      phone app (an iOS app known as mediGrid (IRISS Medical Technologies, UK; CE Marked, HIPAA&#xD;
      compliant). This study will evaluate the degree of translational movement loss from orbital&#xD;
      implant to ocular prosthesis and analysis will include comparisons between hydroxyapatite and&#xD;
      acrylic implants and in patients without an orbital implant, also known as post-enucleation&#xD;
      socket syndrome (PESS). A part of this study will also evaluate the accuracy of the two&#xD;
      softwares Image J as well as the mediGrid smartphone app in measuring prosthesis motility by&#xD;
      comparing it to the ruler as a &quot;gold&quot; standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 18, 2019</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>
    <intervention_model_description>Pilot study to evaluate the mediGrid App against the gold standard rule as a measuring device.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Non-masked study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Measurements of orbital implant and ocular prosthesis motility via the mediGrid app</measure>
    <time_frame>1 Month</time_frame>
    <description>Orbital implant motility in patient with enucleated sockets will be measured with a mediGrid app. The app will evaluate the degree of translational movement loss from orbital implant to ocular prosthesis.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Enucleated; Eye</condition>
  <arm_group>
    <arm_group_label>OCULAR PROSTHESIS MOTILITY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants ocular prosthesis motility will be measured using the mediGrid app, Image J software in comparison to the ruler as a gold standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IRISS Medical Technologies mediGrid app</intervention_name>
    <description>IRISS mediGrid is standalone software, loaded on a mobile electronic platform, which is intended to record and document ophthalmic and other bodily characteristics and to aid in the diagnosis of abnormalities.</description>
    <arm_group_label>OCULAR PROSTHESIS MOTILITY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with surgery to remove one eye&#xD;
&#xD;
          -  Able to give consent and understand the study&#xD;
&#xD;
          -  Able to cooperate by following instructions (keeping head still, perform gaze&#xD;
             movements)&#xD;
&#xD;
          -  Enucleation was performed with the integrated implant technique (recti muscles sutured&#xD;
             directly to the scleral cap or the mesh around the implant in a location corresponding&#xD;
             to muscle insertion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radiotherapy to socket&#xD;
&#xD;
          -  Chemotherapy&#xD;
&#xD;
          -  Implant exposure repair&#xD;
&#xD;
          -  Secondary orbital implant&#xD;
&#xD;
          -  Concurrent socket pathology:&#xD;
&#xD;
          -  Socket infection&#xD;
&#xD;
          -  Socket exposure&#xD;
&#xD;
          -  Giant papillary conjunctivitis&#xD;
&#xD;
          -  Presence of ocular motility disorders on either side of the face, such as nystagmus,&#xD;
             known muscle restrictive disorders (thyroid eye disease, previous trauma, idiopathic&#xD;
             orbital inflammatory disease) and neurological disorders (cranial neuropathies,&#xD;
             multiple sclerosis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mandeep Sagoo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moorfields Eye Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Moorfields Eye Hospital NHS Foundation Trust, 162 City Road</name>
      <address>
        <city>London</city>
        <zip>EC1V 2PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>August 19, 2020</last_update_submitted>
  <last_update_submitted_qc>August 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prosthetic</keyword>
  <keyword>Eye</keyword>
  <keyword>Enucleation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All participant data will remain within the sponsor organisation.</ipd_description>
  </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/NCT03819621
org study id: SAGM1005
nct id: NCT03819621
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the degree of translational movement loss from orbital implant to
      ocular prosthesis. This will be measured using two software applications - Image J as well as
      the mediGrid smartphone app in measuring prosthesis motility by comparing it to the ruler as
      a "gold" standard.
The fit and function of an ocular prosthetic determines the effective motility (movement)
      within the patient's eye socket. A poor fitting ocular prosthesis will lead to poor motility,
      patient discomfort and increased mucus discharge, and can risk the integrity of the anterior
      surface of the implanted orbit. Currently the method to determine best fit of the ocular
      prosthesis is dependent upon the ocularist's skill in adding or subtracting material from the
      wax model that is replicated from an initial alginate impression of the patient's eye socket.

      The proposal of this study is to utilise digital imaging to capture images to measure the
      motility of both the orbital implant and the ocular prosthesis. Two methods will be compared:
      excursion measurements on a photograph using digital software (Image J) versus use of a smart
      phone app (an iOS app known as mediGrid (IRISS Medical Technologies, UK; CE Marked, HIPAA
      compliant). This study will evaluate the degree of translational movement loss from orbital
      implant to ocular prosthesis and analysis will include comparisons between hydroxyapatite and
      acrylic implants and in patients without an orbital implant, also known as post-enucleation
      socket syndrome (PESS). A part of this study will also evaluate the accuracy of the two
      softwares Image J as well as the mediGrid smartphone app in measuring prosthesis motility by
      comparing it to the ruler as a "gold" standard.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilot study to evaluate the mediGrid App against the gold standard rule as a measuring device.
primary purpose: Other
masking: None (Open Label)
masking description: Non-masked study.
measure: Measurements of orbital implant and ocular prosthesis motility via the mediGrid app
time frame: 1 Month
description: Orbital implant motility in patient with enucleated sockets will be measured with a mediGrid app. The app will evaluate the degree of translational movement loss from orbital implant to ocular prosthesis.
arm group label: OCULAR PROSTHESIS MOTILITY
arm group type: Experimental
description: All participants ocular prosthesis motility will be measured using the mediGrid app, Image J software in comparison to the ruler as a gold standard.
intervention type: Device
intervention name: IRISS Medical Technologies mediGrid app
description: IRISS mediGrid is standalone software, loaded on a mobile electronic platform, which is intended to record and document ophthalmic and other bodily characteristics and to aid in the diagnosis of abnormalities.
arm group label: OCULAR PROSTHESIS MOTILITY
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mandeep Sagoo
role: Principal Investigator
affiliation: Moorfields Eye Hospital NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: All participant data will remain within the sponsor organisation.