<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/NCT03269123</url>
  </required_header>
  <id_info>
    <org_study_id>5663</org_study_id>
    <nct_id>NCT03269123</nct_id>
  </id_info>
  <brief_title>A Mechanical Device for Blepharospasm</brief_title>
  <official_title>Clinical Trial of a Mechanical Device for the Treatment of Blepharospasm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Dystonia Society of the United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Globsource UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Statsconsultancy Ltd, Amersham, Buckinghamshire,UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oxford University Hospitals NHS 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>
      Idiopathic blepharospasm (IB) is a rare but well characterised adult onset focal dystonia&#xD;
      that may cause severe visual disability. The most effective treatment is with periodic&#xD;
      injections of botulinum toxin into the pre-tarsal and / or pre-septal orbicularis oculi&#xD;
      muscles bilaterally. However, even with treatment, practical visual function often remains&#xD;
      compromised.&#xD;
&#xD;
      A subset of IB sufferers find that eye opening improves with focal unilateral digital&#xD;
      pressure usually on a specific point on the temple. The Investigators have developed a&#xD;
      spectacle mounted spring-loaded prosthesis (the &quot;Pressop&quot; device) to apply continuous&#xD;
      individually localised focal pressure on the temple to mimic the effect of finger pressure.&#xD;
&#xD;
      The Investigators recommended a trial of this simple safe device in those IB patients who&#xD;
      report improvement in eye opening with focal digital temple pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Idiopathic blepharospasm is a rare chronic neuro-ophthalmic disorder that causes substantial&#xD;
      visual handicap &amp; compromises quality of life. It affects adults, women more than men,&#xD;
      usually beginning in the 5th or 6th decade and consists of repeated forceful bilateral spasms&#xD;
      of eye closure with photophobia and ocular surface discomfort. In up to a third of cases&#xD;
      there are synchronous mid and / or lower facial spasms and the spectrum of disorder extends&#xD;
      to cranial dystonia involving jaw &amp; neck muscle spasms (e.g. antecollis or retrocollis).&#xD;
      Practical visual function is variably affected but most patients will have to stop driving,&#xD;
      many cannot work, manage the house or even leave the house unaccompanied. Leisure activities&#xD;
      such as reading &amp; watching television are compromised or impossible, and secondary mood&#xD;
      dysphoria and depression are common.&#xD;
&#xD;
      In some cases, patients have discovered that applying focal finger pressure, usually to the&#xD;
      temple, relieves or even abolishes the spasms for the duration of the application. It is,&#xD;
      however, difficult for the patient to sustain the finger pressure and impossible to apply it&#xD;
      during activities when eyesight is important e.g. driving, typing or other bimanual tasks.&#xD;
      The phenomenon can be regarded as the equivalent of the sensory trick (ST or geste&#xD;
      antagonistique) seen in some cases of spasmodic torticollis whereby finger tip pressure on&#xD;
      the chin prevents or reduces the muscle spasms in the neck and allows the head to be held&#xD;
      straight.&#xD;
&#xD;
      In this study, the Investigators explored the hypothesis that the benefit of the finger-tip&#xD;
      pressure sensory trick could be replicated by a spring-loaded, spectacle mounted device&#xD;
      applying focal pressure to the temple. Following preliminary design trials, the investigators&#xD;
      commissioned a manufacturer to develop a light easily handled pressure device that could be&#xD;
      fixed to the frame of most spectacles. The &quot;Pressop&quot; device fulfils these criteria and was&#xD;
      adopted for the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2010</start_date>
  <completion_date type="Actual">August 8, 2011</completion_date>
  <primary_completion_date type="Actual">August 8, 2011</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>Clinical trial with a single arm</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The study's objective and subjective responses for the use of the device is measured with the CDQ-24 questionnaire and a questionnaire specific to the the device</measure>
    <time_frame>2-3 week trial period</time_frame>
    <description>Outcome measures will be taken from the CDQ-24 assessment carried out before and after using the pressure device demonstrating improved quality of life.The questionnaire specific to the device addresses issues like wearing time, discomfort, suggestions and feedback .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients demonstrating the &quot;Geste Antagoniste&quot; phenomenon.</measure>
    <time_frame>2-3 week trial period</time_frame>
    <description>This proportion will be presented, along with its 95% confidence interval</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Blepharospasm</condition>
  <arm_group>
    <arm_group_label>A device to relieve Blepharospasm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The pressure device known as Pressop1 is the intervention which is attached to the spectacles and worn for 2 weeks prior to retreatment with Botulinum Toxin injections to assess its effectiveness in controlling eyelid spasms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pressop 1</intervention_name>
    <description>A pressure device attached to the spectacles which mimics a sensory trick (geste Antagoniste)</description>
    <arm_group_label>A device to relieve Blepharospasm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult patient with Blepharospasm of sufficient severity to necessitate repeated&#xD;
             Botulinum injections can be included in the study.&#xD;
&#xD;
          -  It is not essential for participants to be spectacle wearers (having a refractive&#xD;
             error) as prescription free (zero power) spectacles can be provided for the purposes&#xD;
             of being able to trial the device .&#xD;
&#xD;
          -  The participants may or may not be currently having Botulinum Toxin injections. Some&#xD;
             of these patients will be known to use the &quot;Geste Antagoniste&quot; phenomenon. Patients&#xD;
             who may not know of this potential therapeutic effect will also be invited to trial&#xD;
             the device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to wear spectacles due to any reason (as the device has to be mounted on the&#xD;
             spectacle frame).&#xD;
&#xD;
          -  Patients who have spasms and twitches of the eyes caused by a different pathology e.g.&#xD;
             Hemi facial Spasm, Parkinson's disease will also be excluded from this trial.&#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>John S Elston, MD FRCS OPTH</last_name>
    <role>Study Director</role>
    <affiliation>Oxford University Hospitals NHS Trust</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oxford University Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Alexina Fantato</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sensory trick</keyword>
  <keyword>Geste Antagoniste</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharospasm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The study findings will be published in the appropriate medical journal</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/NCT03269123
org study id: 5663
nct id: NCT03269123
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Idiopathic blepharospasm (IB) is a rare but well characterised adult onset focal dystonia
      that may cause severe visual disability. The most effective treatment is with periodic
      injections of botulinum toxin into the pre-tarsal and / or pre-septal orbicularis oculi
      muscles bilaterally. However, even with treatment, practical visual function often remains
      compromised.

      A subset of IB sufferers find that eye opening improves with focal unilateral digital
      pressure usually on a specific point on the temple. The Investigators have developed a
      spectacle mounted spring-loaded prosthesis (the "Pressop" device) to apply continuous
      individually localised focal pressure on the temple to mimic the effect of finger pressure.

      The Investigators recommended a trial of this simple safe device in those IB patients who
      report improvement in eye opening with focal digital temple pressure.
Idiopathic blepharospasm is a rare chronic neuro-ophthalmic disorder that causes substantial
      visual handicap & compromises quality of life. It affects adults, women more than men,
      usually beginning in the 5th or 6th decade and consists of repeated forceful bilateral spasms
      of eye closure with photophobia and ocular surface discomfort. In up to a third of cases
      there are synchronous mid and / or lower facial spasms and the spectrum of disorder extends
      to cranial dystonia involving jaw & neck muscle spasms (e.g. antecollis or retrocollis).
      Practical visual function is variably affected but most patients will have to stop driving,
      many cannot work, manage the house or even leave the house unaccompanied. Leisure activities
      such as reading & watching television are compromised or impossible, and secondary mood
      dysphoria and depression are common.

      In some cases, patients have discovered that applying focal finger pressure, usually to the
      temple, relieves or even abolishes the spasms for the duration of the application. It is,
      however, difficult for the patient to sustain the finger pressure and impossible to apply it
      during activities when eyesight is important e.g. driving, typing or other bimanual tasks.
      The phenomenon can be regarded as the equivalent of the sensory trick (ST or geste
      antagonistique) seen in some cases of spasmodic torticollis whereby finger tip pressure on
      the chin prevents or reduces the muscle spasms in the neck and allows the head to be held
      straight.

      In this study, the Investigators explored the hypothesis that the benefit of the finger-tip
      pressure sensory trick could be replicated by a spring-loaded, spectacle mounted device
      applying focal pressure to the temple. Following preliminary design trials, the investigators
      commissioned a manufacturer to develop a light easily handled pressure device that could be
      fixed to the frame of most spectacles. The "Pressop" device fulfils these criteria and was
      adopted for the trial.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Clinical trial with a single arm
primary purpose: Treatment
masking: None (Open Label)
measure: The study's objective and subjective responses for the use of the device is measured with the CDQ-24 questionnaire and a questionnaire specific to the the device
time frame: 2-3 week trial period
description: Outcome measures will be taken from the CDQ-24 assessment carried out before and after using the pressure device demonstrating improved quality of life.The questionnaire specific to the device addresses issues like wearing time, discomfort, suggestions and feedback .
measure: The proportion of patients demonstrating the "Geste Antagoniste" phenomenon.
time frame: 2-3 week trial period
description: This proportion will be presented, along with its 95% confidence interval
arm group label: A device to relieve Blepharospasm
arm group type: Other
description: The pressure device known as Pressop1 is the intervention which is attached to the spectacles and worn for 2 weeks prior to retreatment with Botulinum Toxin injections to assess its effectiveness in controlling eyelid spasms.
intervention type: Device
intervention name: Pressop 1
description: A pressure device attached to the spectacles which mimics a sensory trick (geste Antagoniste)
arm group label: A device to relieve Blepharospasm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John S Elston, MD FRCS OPTH
role: Study Director
affiliation: Oxford University Hospitals NHS Trust
responsible party type: Principal Investigator
investigator affiliation: Oxford University Hospitals NHS Trust
investigator full name: Alexina Fantato
investigator title: Principal Investigator
mesh term: Blepharospasm
sharing ipd: No
ipd description: The study findings will be published in the appropriate medical journal