xml: <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/NCT06040671</url>
    </required_header>
    <id_info>
      <org_study_id>28/RVO-FNOs/2021</org_study_id>
      <nct_id>NCT06040671</nct_id>
    </id_info>
    <brief_title>Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System</brief_title>
    <official_title>Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Ostrava</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Ostrava</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>
        An objective assessment of that part of the spectrum of ophthalmic eyelid surgeries that&#xD;
        focuses on correcting the position of entropy (e.g. ectropion, ptosis surgery) is very&#xD;
        difficult - although it is possible to use different measuring parameters (distance of&#xD;
        pupillary reflexes from the edges of the eyelid), comparing different distances on the face,&#xD;
        exophthalmometry or the lid laxity test - the so-called snap-back test, but all these methods&#xD;
        are based either on the subjective assessment of the examiner or on the correctness of the&#xD;
        attached ruler, and their objectivity is therefore very low.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of the project is to develop a methodology for evaluating the results of operations&#xD;
        using a stereo photographic system, to objectively evaluate the functionality and results of&#xD;
        various eyelid operations, and subsequently to expand the use of the device in other&#xD;
        ophthalmological indications.&#xD;
  &#xD;
        Different files will be created where the effect of different operations will be monitored in&#xD;
        parallel.&#xD;
  &#xD;
        Lateral canthal hinge surgery will be evaluated in the pilot group, and ptosis surgery&#xD;
        through an anterior approach will be evaluated in the second group.&#xD;
  &#xD;
        In all patients, the position of the eyelids, their change before and after surgery, the&#xD;
        periorbital volume, and the relation of the eyelids to the periorbital landscape will be&#xD;
        assessed metrically.&#xD;
  &#xD;
        The Vectra M3 device will be used for the measurement.&#xD;
  &#xD;
        The expected cohort size is 40 patients in each group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 3, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The study subjects will be divided into two groups.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking is used in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Distance between anatomical points on the face</measure>
      <time_frame>6 months</time_frame>
      <description>In all patients, distance between 52 anatomical-topographical points on the face will be measured in millimetres (mm) - change of the position of the eyelids before and after surgery (distance in mm), the relation of the eyelids to the periorbital landscape (distance in mm)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Periorbital volume measurement</measure>
      <time_frame>6 months</time_frame>
      <description>In all patients, the periorbital volume (volume in mm3) will be assessed metrically.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications</measure>
      <time_frame>3 years</time_frame>
      <description>The suitability (YES/NO) of using the Vectra M 3D Imaging System in other ophthalmological indications will be assessed.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Eyelid Ptoses</condition>
    <condition>Ectropion Eyelids</condition>
    <condition>Entropion;Eye</condition>
    <arm_group>
      <arm_group_label>Lateral canthal hinge surgery patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergoing lateral canthal hinge surgery will be enrolled in this group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ptosis surgery patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergoing ptosis surgery will be enrolled in this group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vectra M3 imaging</intervention_name>
      <description>Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.</description>
      <arm_group_label>Lateral canthal hinge surgery patients</arm_group_label>
      <arm_group_label>Ptosis surgery patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eyelid ptosis&#xD;
  &#xD;
            -  Eyelid entropion&#xD;
  &#xD;
            -  Eyelid ectropion&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to participate in the study&#xD;
  &#xD;
            -  Not signing the Informed Consent Form&#xD;
  &#xD;
            -  Inability/reluctance to cooperate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Adam Kopecký, MD,PhD,FEBO</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital Ostrava</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiří Hynčica</last_name>
      <phone>0042059737</phone>
      <phone_ext>2587</phone_ext>
      <email>jiri.hyncica@fno.cz</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospital Ostrava</name>
        <address>
          <city>Ostrava</city>
          <state>Moravian-Silesian Region</state>
          <zip>70852</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiří Hynčica</last_name>
        <phone>0042059737</phone>
        <phone_ext>2587</phone_ext>
        <email>jiri.hyncica@fno.cz</email>
      </contact>
      <investigator>
        <last_name>Adam Kopecký, MD,PhD,FEBO</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jan Němčanský, MD,PhD,MBA</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Václav Dedek, Ing.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jana Dvořáková, Mgr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>October 31, 2022</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Vectra M3 device</keyword>
    <keyword>Eyelid Ptoses</keyword>
    <keyword>stereo photographic system</keyword>
    <keyword>eyelid surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Entropion</mesh_term>
      <mesh_term>Ectropion</mesh_term>
      <mesh_term>Blepharoptosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to make individual participant data available to other researchers; however, the data may be provided upon request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040671
  org study id: 28/RVO-FNOs/2021
  nct id: NCT06040671
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  An objective assessment of that part of the spectrum of ophthalmic eyelid surgeries that
        focuses on correcting the position of entropy (e.g. ectropion, ptosis surgery) is very
        difficult - although it is possible to use different measuring parameters (distance of
        pupillary reflexes from the edges of the eyelid), comparing different distances on the face,
        exophthalmometry or the lid laxity test - the so-called snap-back test, but all these methods
        are based either on the subjective assessment of the examiner or on the correctness of the
        attached ruler, and their objectivity is therefore very low.
  The goal of the project is to develop a methodology for evaluating the results of operations
        using a stereo photographic system, to objectively evaluate the functionality and results of
        various eyelid operations, and subsequently to expand the use of the device in other
        ophthalmological indications.
  
        Different files will be created where the effect of different operations will be monitored in
        parallel.
  
        Lateral canthal hinge surgery will be evaluated in the pilot group, and ptosis surgery
        through an anterior approach will be evaluated in the second group.
  
        In all patients, the position of the eyelids, their change before and after surgery, the
        periorbital volume, and the relation of the eyelids to the periorbital landscape will be
        assessed metrically.
  
        The Vectra M3 device will be used for the measurement.
  
        The expected cohort size is 40 patients in each group.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The study subjects will be divided into two groups.
  primary purpose: Diagnostic
  masking: None (Open Label)
  masking description: No masking is used in the study.
  measure: Distance between anatomical points on the face
  time frame: 6 months
  description: In all patients, distance between 52 anatomical-topographical points on the face will be measured in millimetres (mm) - change of the position of the eyelids before and after surgery (distance in mm), the relation of the eyelids to the periorbital landscape (distance in mm)
  measure: Periorbital volume measurement
  time frame: 6 months
  description: In all patients, the periorbital volume (volume in mm3) will be assessed metrically.
  measure: The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications
  time frame: 3 years
  description: The suitability (YES/NO) of using the Vectra M 3D Imaging System in other ophthalmological indications will be assessed.
  arm group label: Lateral canthal hinge surgery patients
  arm group type: Experimental
  description: Patients undergoing lateral canthal hinge surgery will be enrolled in this group.
  arm group label: Ptosis surgery patients
  arm group type: Experimental
  description: Patients undergoing ptosis surgery will be enrolled in this group.
  intervention type: Other
  intervention name: Vectra M3 imaging
  description: Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.
  arm group label: Lateral canthal hinge surgery patients
  arm group label: Ptosis surgery patients
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Adam Kopecký, MD,PhD,FEBO
  role: Principal Investigator
  affiliation: University Hospital Ostrava
  last name: Jiří Hynčica
  phone: 0042059737
  phone ext: 2587
  email: jiri.hyncica@fno.cz
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Czechia
  responsible party type: Sponsor
  mesh term: Entropion
  mesh term: Ectropion
  mesh term: Blepharoptosis
  sharing ipd: No
  ipd description: There is no plan to make individual participant data available to other researchers; however, the data may be provided upon request.