<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/NCT02988856</url>
  </required_header>
  <id_info>
    <org_study_id>15-027H</org_study_id>
    <nct_id>NCT02988856</nct_id>
  </id_info>
  <brief_title>Magnetic Correction of Eye Lid Paralysis</brief_title>
  <official_title>Non-surgical Correction of Eye Lid Paralysis With External Magnet Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kevin Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts Eye and Ear Infirmary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective 1: Determine the safety and feasibility of externally mounted magnets for extended&#xD;
      management of chronic eyelid movement disorders by measuring visual acuity and corneal and&#xD;
      skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the&#xD;
      relative efficacy of external magnetic devices by comparing them to externally mounted lid&#xD;
      weights and ptosis crutches using rating scales and video analysis of blink biomechanics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two major types of eye lid movement disorders include lagophthalmos (incomplete closure of&#xD;
      the eyelids) and blepharoptosis (incomplete opening of the eyelids). Both of these conditions&#xD;
      occur because of a disruption in the normal agonist-antagonist neuro-muscular complex&#xD;
      balance. Generally paralysis of the eyelid or facial muscles is responsible for the&#xD;
      abnormality (the eyelids can close but not open, or open but not close). An external device,&#xD;
      if able to generate an appropriately balanced force, could restore eyelid movement by&#xD;
      performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and&#xD;
      the functioning eyelid closure muscle could overcome the device's force. In prior work the&#xD;
      investigators established proof-of-concept data demonstrating safety and efficacy for&#xD;
      temporary management of ptosis up to 2 hour per day for 2 weeks. Preliminary data suggest&#xD;
      similar safety for lagophthalmos. This study will expand on this preliminary work to examine&#xD;
      longer wear times, home use, and feasibility for a wider range of eye lid disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">May 14, 2019</completion_date>
  <primary_completion_date type="Actual">May 14, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rating Scale of Skin Integrity</measure>
    <time_frame>Baseline and up to 32 weeks</time_frame>
    <description>Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale</measure>
    <time_frame>Baseline and up to 32 weeks</time_frame>
    <description>Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Acuity</measure>
    <time_frame>Baseline and up to 32 weeks</time_frame>
    <description>Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Blepharoptosis</condition>
  <condition>Lagophthalmos</condition>
  <condition>Facial Paralysis</condition>
  <arm_group>
    <arm_group_label>Magnetic lid system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will trial a commercially available device and an experimental magnetic device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic lid system</intervention_name>
    <description>Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.</description>
    <arm_group_label>Magnetic lid system</arm_group_label>
    <other_name>Magnetic Levator and Magnetic Orbicularis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of an eyelid movement disorder for at least one eye, moderate cognitive&#xD;
             function or better defined as greater than or equal to 18 out of 30 on a pre-screening&#xD;
             of the Mini-Mental State Exam, age 5 or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of an eyelid movement disorder or presence of a corneal ulcer. Those with a&#xD;
             corneal ulcer are at risk for permanent loss of vision and should be managed with&#xD;
             proven methods. Age less than 5, Severe Cognitive impairment defined as Mini-mental&#xD;
             score &lt;18, behaviors consistent with delirium (combinations of disorientation,&#xD;
             hallucinations, delusions, and incoherent speech), or lethargy. These individuals must&#xD;
             be excluded since participation requires competent self-care, reliable responses and&#xD;
             cooperation during fitting of the devices.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin E Houston, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts Eye and Ear</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ophthalmology of Clinical Research Office, Mass Eye and Ear</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>021141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Singh NK, Paschalis EI, Tomasi M, Rizzo JF, Houston KE. The boston blink-netic project: preliminary outpatient feasibility results (abstract). Optom Vis Sci 2016;93: E-abstract 16118.</citation>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>October 1, 2015</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>June 23, 2020</results_first_submitted>
  <results_first_submitted_qc>October 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 30, 2020</results_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts Eye and Ear Infirmary</investigator_affiliation>
    <investigator_full_name>Kevin Houston</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bell Palsy</mesh_term>
    <mesh_term>Facial Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Blepharoptosis</mesh_term>
    <mesh_term>Lagophthalmos</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02988856/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Magnetic Lid System</title>
          <description>Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Magnetic Lid System</title>
          <description>All participants will trial a commercially available device and an experimental magnetic device.&#xD;
Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rating Scale of Skin Integrity</title>
        <description>Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema.</description>
        <time_frame>Baseline and up to 32 weeks</time_frame>
        <population>Erythema rating in participants who had worn the MLP for 1 to 32 weeks. All the ratings each subject had across all their visits were averaged, and then a group average and std dev calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Magnetic Lid System</title>
            <description>All participants will trial a commercially available device and an experimental magnetic device.&#xD;
Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.</description>
          </group>
        </group_list>
        <measure>
          <title>Rating Scale of Skin Integrity</title>
          <description>Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema.</description>
          <population>Erythema rating in participants who had worn the MLP for 1 to 32 weeks. All the ratings each subject had across all their visits were averaged, and then a group average and std dev calculated.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale</title>
        <description>Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed.</description>
        <time_frame>Baseline and up to 32 weeks</time_frame>
        <population>Participants with ptosis wearing the MLP for 1 or more weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Magnetic Lid System</title>
            <description>All participants will trial a commercially available device and an experimental magnetic device.&#xD;
Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale</title>
          <description>Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed.</description>
          <population>Participants with ptosis wearing the MLP for 1 or more weeks</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Visual Acuity</title>
        <description>Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated.</description>
        <time_frame>Baseline and up to 32 weeks</time_frame>
        <population>Participants who wore the MLP for 1 week or more</population>
        <group_list>
          <group group_id="O1">
            <title>Magnetic Lid System</title>
            <description>All participants will trial a commercially available device and an experimental magnetic device.&#xD;
Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visual Acuity</title>
          <description>Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated.</description>
          <population>Participants who wore the MLP for 1 week or more</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Magnetic Lid System</title>
          <description>All participants will trial a commercially available device and an experimental magnetic device.&#xD;
Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal staining</sub_title>
                <description>Increase in corneal staining over safety cutoff (&gt;grade 2 increase)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kevin Houston</name_or_title>
      <organization>Massachusetts Eye and Ear</organization>
      <phone>617-573-4177</phone>
      <email>kevin_houston@meei.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02988856
org study id: 15-027H
nct id: NCT02988856
lead sponsor: 
has dmc: No
Objective 1: Determine the safety and feasibility of externally mounted magnets for extended
      management of chronic eyelid movement disorders by measuring visual acuity and corneal and
      skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the
      relative efficacy of external magnetic devices by comparing them to externally mounted lid
      weights and ptosis crutches using rating scales and video analysis of blink biomechanics.
Two major types of eye lid movement disorders include lagophthalmos (incomplete closure of
      the eyelids) and blepharoptosis (incomplete opening of the eyelids). Both of these conditions
      occur because of a disruption in the normal agonist-antagonist neuro-muscular complex
      balance. Generally paralysis of the eyelid or facial muscles is responsible for the
      abnormality (the eyelids can close but not open, or open but not close). An external device,
      if able to generate an appropriately balanced force, could restore eyelid movement by
      performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and
      the functioning eyelid closure muscle could overcome the device's force. In prior work the
      investigators established proof-of-concept data demonstrating safety and efficacy for
      temporary management of ptosis up to 2 hour per day for 2 weeks. Preliminary data suggest
      similar safety for lagophthalmos. This study will expand on this preliminary work to examine
      longer wear times, home use, and feasibility for a wider range of eye lid disorders.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rating Scale of Skin Integrity
time frame: Baseline and up to 32 weeks
description: Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema.
measure: Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale
time frame: Baseline and up to 32 weeks
description: Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed.
measure: Change in Visual Acuity
time frame: Baseline and up to 32 weeks
description: Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated.
arm group label: Magnetic lid system
arm group type: Experimental
description: All participants will trial a commercially available device and an experimental magnetic device.
intervention type: Device
intervention name: Magnetic lid system
description: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
arm group label: Magnetic lid system
other name: Magnetic Levator and Magnetic Orbicularis
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin E Houston, OD
role: Principal Investigator
affiliation: Massachusetts Eye and Ear
facility: 
country: United States
citation: Singh NK, Paschalis EI, Tomasi M, Rizzo JF, Houston KE. The boston blink-netic project: preliminary outpatient feasibility results (abstract). Optom Vis Sci 2016;93: E-abstract 16118.
responsible party type: Sponsor-Investigator
investigator affiliation: Massachusetts Eye and Ear Infirmary
investigator full name: Kevin Houston
investigator title: Principal Investigator
mesh term: Bell Palsy
mesh term: Facial Paralysis
mesh term: Paralysis
mesh term: Blepharoptosis
mesh term: Lagophthalmos
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 