<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/NCT03812016</url>
  </required_header>
  <id_info>
    <org_study_id>EDAHP107026</org_study_id>
    <nct_id>NCT03812016</nct_id>
  </id_info>
  <brief_title>A Real-time Magnetic Device for Temporary Management of Blepharoptosis</brief_title>
  <official_title>A Real-time Magnetic Device for Management of Blepharoptosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>E-DA Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>E-DA Hospital</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>
      To develop a real-time magnetic device prototype for temporary management of blepharoptosis&#xD;
      and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual&#xD;
      axis obstruction, blurred vision, foreign body sensation over the cornea, burning or hot&#xD;
      sensation over facial skin, and erythema or pruritus over the eyelid, by performing a human&#xD;
      trial on patients with unilateral blepharoptosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The magnetic device prototype primarily comprises 2 matched pairs of one near-infrared&#xD;
      light-emitting diode and one photodiode sensor, a permanent electromagnetic actuator, an iron&#xD;
      sheet (for affixing to the paralytic upper eyelid), and a biosignal acquisition module along&#xD;
      with a power supply unit providing a wired connection with optical sensors and a permanent&#xD;
      electromagnetic actuator. Before the study, the differences between the affected and&#xD;
      unaffected palpebral fissure heights were directly measured using a ruler. During the test&#xD;
      after the wearing of the prototype, the distance of the paralytic eyelid lift was documented&#xD;
      and the corrected distance (gain) of the paralytic upper eyelid was calculated. The efficacy&#xD;
      and safety of the device prototype were assessed. The efficacy was evaluated according to the&#xD;
      synchronous blinks and gain of paralytic eyelid lifts. Subjective sensation and complications&#xD;
      were assessed by visual axis obstruction, blurred vision, foreign body sensation over the&#xD;
      cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid.&#xD;
      After the completion of the study procedure, the eyelid skin integrity, subjective sensation&#xD;
      and discomfort were examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    The device prototype was broken and fixed in 2020. The new simplified and miniaturized device&#xD;
    will be finished and used on April 1, 2022.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 1, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</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>Evaluation of the efficacy by measuring changes in distance.</measure>
    <time_frame>10-minutes after completion of the testing</time_frame>
    <description>The investigators assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention by a ruler and a software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale.</measure>
    <time_frame>10-minutes after completion of the testing</time_frame>
    <description>The investigators assess discomfort of blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid after the wearing of the device. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 1 indicating no discomfort at all, score 2 moderate discomfort, and score 3 extremely discomfort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the efficacy by measuring changes in distance.</measure>
    <time_frame>3-months</time_frame>
    <description>The investigators assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention (3 times) by a ruler and a software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale.</measure>
    <time_frame>3-months</time_frame>
    <description>The investigators assess discomfort of blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid after the wearing of the device. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 1 indicating no discomfort at all, score 2 moderate discomfort, and score 3 extremely discomfort.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Blepharoptosis</condition>
  <arm_group>
    <arm_group_label>Determine device feasibility</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>by evaluating efficacy and safety of the device. Test the device one time ( duration: 30-120 mins/each time) and 3 times within 3 months.&#xD;
Intervention: using the magnetic device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic device</intervention_name>
    <description>The device comprises 1 or 2 matched pairs of one near-infrared light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and one sensor (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet, and a biosignal acquisition module. The efficacy and safety were assessed using the magnetic device.</description>
    <arm_group_label>Determine device feasibility</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with unilateral ptosis; they are capable of understanding and complying with&#xD;
             protocol requirements&#xD;
&#xD;
          -  Aged 18 years old or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper eyelid scar, contracture, or fibrosis due to previous surgical intervention(s)&#xD;
             or traffic accident&#xD;
&#xD;
          -  Patients with psychiatric (or mental) disorders; they are unable to cooperate or&#xD;
             follow the study procedure&#xD;
&#xD;
          -  Children younger than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuan-Kun Tu</last_name>
    <role>Study Chair</role>
    <affiliation>E-Da Hospital, Kaohsiung, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>E-Da Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>82445</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>February 3, 2022</last_update_submitted>
  <last_update_submitted_qc>February 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>E-DA Hospital</investigator_affiliation>
    <investigator_full_name>Tu, Yuan-Kun</investigator_full_name>
    <investigator_title>Administrator</investigator_title>
  </responsible_party>
  <keyword>Blepharoptosis</keyword>
  <keyword>Blink restoration</keyword>
  <keyword>Magnetic device</keyword>
  <keyword>Oculomotor nerve palsy</keyword>
  <keyword>Ptosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharoptosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03812016
org study id: EDAHP107026
nct id: NCT03812016
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To develop a real-time magnetic device prototype for temporary management of blepharoptosis
      and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual
      axis obstruction, blurred vision, foreign body sensation over the cornea, burning or hot
      sensation over facial skin, and erythema or pruritus over the eyelid, by performing a human
      trial on patients with unilateral blepharoptosis.
The magnetic device prototype primarily comprises 2 matched pairs of one near-infrared
      light-emitting diode and one photodiode sensor, a permanent electromagnetic actuator, an iron
      sheet (for affixing to the paralytic upper eyelid), and a biosignal acquisition module along
      with a power supply unit providing a wired connection with optical sensors and a permanent
      electromagnetic actuator. Before the study, the differences between the affected and
      unaffected palpebral fissure heights were directly measured using a ruler. During the test
      after the wearing of the prototype, the distance of the paralytic eyelid lift was documented
      and the corrected distance (gain) of the paralytic upper eyelid was calculated. The efficacy
      and safety of the device prototype were assessed. The efficacy was evaluated according to the
      synchronous blinks and gain of paralytic eyelid lifts. Subjective sensation and complications
      were assessed by visual axis obstruction, blurred vision, foreign body sensation over the
      cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid.
      After the completion of the study procedure, the eyelid skin integrity, subjective sensation
      and discomfort were examined.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of the efficacy by measuring changes in distance.
time frame: 10-minutes after completion of the testing
description: The investigators assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention by a ruler and a software.
measure: Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale.
time frame: 10-minutes after completion of the testing
description: The investigators assess discomfort of blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid after the wearing of the device. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 1 indicating no discomfort at all, score 2 moderate discomfort, and score 3 extremely discomfort.
measure: Evaluation of the efficacy by measuring changes in distance.
time frame: 3-months
description: The investigators assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention (3 times) by a ruler and a software.
measure: Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale.
time frame: 3-months
description: The investigators assess discomfort of blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid after the wearing of the device. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 1 indicating no discomfort at all, score 2 moderate discomfort, and score 3 extremely discomfort.
arm group label: Determine device feasibility
arm group type: Experimental
description: by evaluating efficacy and safety of the device. Test the device one time ( duration: 30-120 mins/each time) and 3 times within 3 months.
Intervention: using the magnetic device
intervention type: Device
intervention name: Magnetic device
description: The device comprises 1 or 2 matched pairs of one near-infrared light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and one sensor (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet, and a biosignal acquisition module. The efficacy and safety were assessed using the magnetic device.
arm group label: Determine device feasibility
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yuan-Kun Tu
role: Study Chair
affiliation: E-Da Hospital, Kaohsiung, Taiwan
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: E-DA Hospital
investigator full name: Tu, Yuan-Kun
investigator title: Administrator
mesh term: Blepharoptosis
sharing ipd: No