<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/NCT02226016</url>
  </required_header>
  <id_info>
    <org_study_id>LEVATOR01</org_study_id>
    <nct_id>NCT02226016</nct_id>
  </id_info>
  <brief_title>Levator Muscle Strength Evaluation</brief_title>
  <official_title>Quantitative Evaluation of Levator Palpebra Muscle Strength</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess a new technique of measurement for the levator muscle.&#xD;
&#xD;
      this measurement may be applied during a clinical evaluation of eyelid malposition.&#xD;
&#xD;
      our purpose is to quantify the levator muscle strength and to corelate it to standard levator&#xD;
      muscle strength assessment techniques routinley used in the oculoplastic clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will include patients refered to our oculoplastic department for evaluation of&#xD;
      eyelid disorders (ptosis or eyelid malpositions due to various mechanical, muscular,&#xD;
      neurogenic factors).&#xD;
&#xD;
      all patients will be over 21 years old, with eligibility for signing an informed concent&#xD;
      form.&#xD;
&#xD;
      all patients will undergo a full clinical standard evaluation of eyelid malposition made as&#xD;
      part of the routine evaluation of eyelid malpositions. as part of this evaluation- the&#xD;
      levator muscles strength will be measured by monitoring the amount of millimeters of&#xD;
      difference between the uper lid closed and open position (a regular technique for levator&#xD;
      muscles assessment).&#xD;
&#xD;
      a second levator muscle strength evaluation will include the study device. this device is&#xD;
      used for weight evaluation of objects. an object is measured by attaching it to the device&#xD;
      with a metal hook and a string. the device is hand held.&#xD;
&#xD;
      for measurements of the upper lid force the device will be temporarily attached to the upper&#xD;
      eyelid using a specially designed base made in the shape of the eyelid. the attachment will&#xD;
      be using a sterile medical tape (plaster). this sterile base is attached to the outer eyelid&#xD;
      and does not involve in any point any harm to the continuity of the skin, injections , harm&#xD;
      or contact to the eyeball or any other parts of the eye. this base is attached from its back&#xD;
      to a string witch attaches to the measuring device. the investigator holds the measuring&#xD;
      device and asks the patient to open and close his eyes. the force that is generated while&#xD;
      opening the upper lid is measured (in grams) by the device.&#xD;
&#xD;
      this evaluation will allow a unique first proper estimation of the true levator palpebra&#xD;
      strength. it will be compared to the levators' strength as estimated using the routine&#xD;
      techniques for assessing their efficacy.&#xD;
&#xD;
      the assessment will be made one time for each patient. after the measurement- the sterile&#xD;
      tape will be removed and will be disposed. no further interventions will be made for each&#xD;
      patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>levator muscle strength quantified in grams using a unique measuring device.</measure>
    <time_frame>each patient will undergo two measurments of the levator muscle strength using the study device during a single clinical evaluation. no further evaluations will be made for the same patient throughout the study.</time_frame>
    <description>we aim to accurately measure the levator muscle strength in grams. the levator muscle will be noninvasively attached to the device using a string. while changing eye position from closure to opening- the force generated by the eyelid will be reflected through the string to the measuring device and will be displayed in grams. this will reflect the levator muscles strength.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>repeatability of the measurements</measure>
    <time_frame>each patient will undergo two measurments of the levator muscle strength using the study device during a single clinical evaluation. no further evaluations will be made for the same patient throughout the study.</time_frame>
    <description>we wish to evaluate the validity of these muscle strength assessments. for each patient two muscle measurements will be done by a single clinician. their results will be furtherly assessed for repeatability of the measurement.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Ptosis</condition>
  <arm_group>
    <arm_group_label>Ptosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device (measurement of levator strength in patients with upper lid ptosis)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FG-5000A</intervention_name>
    <description>a measuring device for the assessment of levator muscle strength</description>
    <arm_group_label>Ptosis</arm_group_label>
    <other_name>an experimental measurinf device for a mechanical evaluation of the levator palpebra superioris muscle strength</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        eligible for signing an informed concent form refered for eyelid evaluation in the&#xD;
        oculoplastic department, Meir Mc&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        previous eyelid surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arik Nemet, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nemet Arik, DR</last_name>
    <phone>+972-9747-2154</phone>
    <email>nemet.arik@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ofir Shay, DR</last_name>
    <phone>+972-9747-2154</phone>
    <email>shayofir1@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Meir Medical center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>August 23, 2014</last_update_submitted>
  <last_update_submitted_qc>August 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>shay ofir</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>ptosis</keyword>
  <keyword>blepharochalasis</keyword>
  <keyword>dermatochalasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</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/NCT02226016
org study id: LEVATOR01
nct id: NCT02226016
lead sponsor: 
has dmc: No
The purpose of this study is to assess a new technique of measurement for the levator muscle.

      this measurement may be applied during a clinical evaluation of eyelid malposition.

      our purpose is to quantify the levator muscle strength and to corelate it to standard levator
      muscle strength assessment techniques routinley used in the oculoplastic clinic.
This study will include patients refered to our oculoplastic department for evaluation of
      eyelid disorders (ptosis or eyelid malpositions due to various mechanical, muscular,
      neurogenic factors).

      all patients will be over 21 years old, with eligibility for signing an informed concent
      form.

      all patients will undergo a full clinical standard evaluation of eyelid malposition made as
      part of the routine evaluation of eyelid malpositions. as part of this evaluation- the
      levator muscles strength will be measured by monitoring the amount of millimeters of
      difference between the uper lid closed and open position (a regular technique for levator
      muscles assessment).

      a second levator muscle strength evaluation will include the study device. this device is
      used for weight evaluation of objects. an object is measured by attaching it to the device
      with a metal hook and a string. the device is hand held.

      for measurements of the upper lid force the device will be temporarily attached to the upper
      eyelid using a specially designed base made in the shape of the eyelid. the attachment will
      be using a sterile medical tape (plaster). this sterile base is attached to the outer eyelid
      and does not involve in any point any harm to the continuity of the skin, injections , harm
      or contact to the eyeball or any other parts of the eye. this base is attached from its back
      to a string witch attaches to the measuring device. the investigator holds the measuring
      device and asks the patient to open and close his eyes. the force that is generated while
      opening the upper lid is measured (in grams) by the device.

      this evaluation will allow a unique first proper estimation of the true levator palpebra
      strength. it will be compared to the levators' strength as estimated using the routine
      techniques for assessing their efficacy.

      the assessment will be made one time for each patient. after the measurement- the sterile
      tape will be removed and will be disposed. no further interventions will be made for each
      patient.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: levator muscle strength quantified in grams using a unique measuring device.
time frame: each patient will undergo two measurments of the levator muscle strength using the study device during a single clinical evaluation. no further evaluations will be made for the same patient throughout the study.
description: we aim to accurately measure the levator muscle strength in grams. the levator muscle will be noninvasively attached to the device using a string. while changing eye position from closure to opening- the force generated by the eyelid will be reflected through the string to the measuring device and will be displayed in grams. this will reflect the levator muscles strength.
measure: repeatability of the measurements
time frame: each patient will undergo two measurments of the levator muscle strength using the study device during a single clinical evaluation. no further evaluations will be made for the same patient throughout the study.
description: we wish to evaluate the validity of these muscle strength assessments. for each patient two muscle measurements will be done by a single clinician. their results will be furtherly assessed for repeatability of the measurement.
arm group label: Ptosis
arm group type: Experimental
description: Device (measurement of levator strength in patients with upper lid ptosis)
intervention type: Device
intervention name: FG-5000A
description: a measuring device for the assessment of levator muscle strength
arm group label: Ptosis
other name: an experimental measurinf device for a mechanical evaluation of the levator palpebra superioris muscle strength
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Arik Nemet, Dr
role: Principal Investigator
affiliation: Meir Medical Center
last name: Nemet Arik, DR
phone: +972-9747-2154
email: nemet.arik@gmail.com
last name: Ofir Shay, DR
phone: +972-9747-2154
email: shayofir1@gmail.com
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: shay ofir
investigator title: Investigator
mesh term: Prolapse