<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/NCT03749759</url>
  </required_header>
  <id_info>
    <org_study_id>Neuromaster</org_study_id>
    <nct_id>NCT03749759</nct_id>
  </id_info>
  <brief_title>Perioperative Stress and Pain Perception of Second Eye Cataract Surgery</brief_title>
  <official_title>Pain Perception and Discomfort of Second Eye Cataract Surgery in Comparison With the First Eye in Correlation With Perioperative Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Prof. Dr. Oliver Findl, MBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vienna Institute for Research in Ocular Surgery</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of this study is to find a correlation between agitation (stress) indicating&#xD;
      parameters and the pain perception during second eye cataract surgery, compared to first eye&#xD;
      cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cataract, which is the clouding of the eye's natural lens as a result of aging or injury,&#xD;
      is the leading cause of preventable blindness worldwide. As one of the of the most common&#xD;
      surgical procedures, cataract surgery is performed almost 22 million times worldwide each&#xD;
      year. The World Health Organisation estimates that by 2020 more than 32 million cataract&#xD;
      surgeries will take place globally per annum.&#xD;
&#xD;
      Phacoemulsification cataract surgery in topical anaesthesia has become the anaesthetic method&#xD;
      of choice since first described by Fichman in 1992. Although this procedure has proven to be&#xD;
      relatively painless, safe and effective, patients often report increased pain or discomfort&#xD;
      during surgery of the second eye. Several studies were performed to find out if there was any&#xD;
      proof to that common finding and some tried to find a correlation to fear and anxiety using&#xD;
      standardized questionnaires.&#xD;
&#xD;
      In one study of 65 patients there was a subtle increase in pain in the second surgery&#xD;
      relative to the first which appeared to be associated with decreased preoperative anxiety.&#xD;
      Another study found that previous cataract extraction correlated negatively, but weakly with&#xD;
      preoperative anxiety.&#xD;
&#xD;
      A study of 70 patients having first cataract extraction found no difference in mean pain&#xD;
      scores, fear and anxiety when compared with a second, independent population of 57 patients&#xD;
      having second cataract extraction. A similar outcome was found in 2 other studies where there&#xD;
      was no difference in perceived pain between the first and second cataract surgery.&#xD;
&#xD;
      Summarized, the results in the related literature are controversial concerning the assessment&#xD;
      of pain, fear and anxiety during cataract surgery performed in the second eye.&#xD;
&#xD;
      Emotional stress and anxiety in surgical patients lead to sympathetic stimulation with&#xD;
      tachycardia, hypertension and possible cardiac ischaemia which are haemodynamic stress&#xD;
      responses, triggered by endocrine regulatory mechanisms and the autonomic nervous system with&#xD;
      increased cortisol, adrenaline and noradrenaline blood levels. Furthermore palmar and plantar&#xD;
      sweat glands activity decreases skin resistance which is shown as a surge in electric skin&#xD;
      conductance in bio- feedback measurements.&#xD;
&#xD;
      For obtaining and processing the information about these physiological reactions a system&#xD;
      with the ability to measure and record various bio-signals is needed. These kind of systems&#xD;
      are used for biofeedback. Galvanic Skin response Sensors measure the above mentioned&#xD;
      electrical conductance of the skin. It is used as an indication of psychological and&#xD;
      physiological excitation and thus represents an indicator for the individual's stress&#xD;
      response.&#xD;
&#xD;
      Electromyograph (EMG) uses surface electrodes to measure the electrical activity of the&#xD;
      skeletal muscles when they are relaxed and contracted by detecting the combined electrical&#xD;
      potential generated by the muscle cells. The mean value of the rectified EMG signal of the&#xD;
      upper trapezius muscle increases during stressful conditions and decreases again during&#xD;
      relaxation periods.&#xD;
&#xD;
      Electrocardiogram (ECG) electrodes are used to measure the heart function and further&#xD;
      calculate the heart rate variability (HRV). HRV is defined as the beat-to-beat changes, the&#xD;
      interbeat interval, which is the time between two successive R waves. HRV is considered as a&#xD;
      measure of the interaction between sympathetic and parasympathetic influence on heart rate.&#xD;
      The activation of the sympathetic branch of the autonomic nervous system increases heart&#xD;
      rate, while the activation of the parasympathetic branch, primarily mediated by the vagus&#xD;
      nerve, slows it. These physiological signals provide a reliable measurement of agitation&#xD;
      (stress).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perioperative agitation (stress) measurement</measure>
    <time_frame>12 months</time_frame>
    <description>Perioperative stress will be measured using the BioLink Biofeedback device, which records an electrocardiogram, an electromyogram, skin conductance and respiratory rate. Changes in the different values show how stressed the patient was during the surgeries.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of pain perception</measure>
    <time_frame>12 months</time_frame>
    <description>Pain perception of the patients will be assessed during the two cataract surgeries using an visual analogue scale, where 10 means highest pain and 1 is lowest pain.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">39</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Biofeedback measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A Biofeedback measurement will be done during cataract surgery of both eyes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cataract surgery</intervention_name>
    <description>A biofeedback measurement will be carried out during cataract surgery of both eyes</description>
    <arm_group_label>Biofeedback measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  written informed consent prior to surgery&#xD;
&#xD;
          -  bilateral age-related cataract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  deafness&#xD;
&#xD;
          -  allergy to topical anesthetic agents&#xD;
&#xD;
          -  severe anxiety and involuntary eye and head movements&#xD;
&#xD;
          -  conditions likely to require surgical therapy other than routine phacoemulsification&#xD;
             (eg: traumatic and complicated cataracts)&#xD;
&#xD;
          -  in case of pregnancy (pregnancy test will be taken in women of reproductive age)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>John Falasinnu, MD</last_name>
    <phone>01 91021-57559</phone>
    <email>office@viros.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katharina Kefer</last_name>
    <phone>01 91021-57564</phone>
    <email>office@viros.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vienna Institute for Research in Ocular Surgery (VIROS)</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Falasinnu, MD</last_name>
      <phone>01 910 21-57559</phone>
      <email>office@viros.at</email>
    </contact>
    <contact_backup>
      <last_name>Katharina Kefer</last_name>
      <phone>01 910 21-57564</phone>
      <email>office@viros.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vienna Institute for Research in Ocular Surgery</investigator_affiliation>
    <investigator_full_name>Prim. Prof. Dr. Oliver Findl, MBA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cataract</keyword>
  <keyword>Cataract surgery</keyword>
  <keyword>Biofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03749759
org study id: Neuromaster
nct id: NCT03749759
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Purpose of this study is to find a correlation between agitation (stress) indicating
      parameters and the pain perception during second eye cataract surgery, compared to first eye
      cataract surgery.
A cataract, which is the clouding of the eye's natural lens as a result of aging or injury,
      is the leading cause of preventable blindness worldwide. As one of the of the most common
      surgical procedures, cataract surgery is performed almost 22 million times worldwide each
      year. The World Health Organisation estimates that by 2020 more than 32 million cataract
      surgeries will take place globally per annum.

      Phacoemulsification cataract surgery in topical anaesthesia has become the anaesthetic method
      of choice since first described by Fichman in 1992. Although this procedure has proven to be
      relatively painless, safe and effective, patients often report increased pain or discomfort
      during surgery of the second eye. Several studies were performed to find out if there was any
      proof to that common finding and some tried to find a correlation to fear and anxiety using
      standardized questionnaires.

      In one study of 65 patients there was a subtle increase in pain in the second surgery
      relative to the first which appeared to be associated with decreased preoperative anxiety.
      Another study found that previous cataract extraction correlated negatively, but weakly with
      preoperative anxiety.

      A study of 70 patients having first cataract extraction found no difference in mean pain
      scores, fear and anxiety when compared with a second, independent population of 57 patients
      having second cataract extraction. A similar outcome was found in 2 other studies where there
      was no difference in perceived pain between the first and second cataract surgery.

      Summarized, the results in the related literature are controversial concerning the assessment
      of pain, fear and anxiety during cataract surgery performed in the second eye.

      Emotional stress and anxiety in surgical patients lead to sympathetic stimulation with
      tachycardia, hypertension and possible cardiac ischaemia which are haemodynamic stress
      responses, triggered by endocrine regulatory mechanisms and the autonomic nervous system with
      increased cortisol, adrenaline and noradrenaline blood levels. Furthermore palmar and plantar
      sweat glands activity decreases skin resistance which is shown as a surge in electric skin
      conductance in bio- feedback measurements.

      For obtaining and processing the information about these physiological reactions a system
      with the ability to measure and record various bio-signals is needed. These kind of systems
      are used for biofeedback. Galvanic Skin response Sensors measure the above mentioned
      electrical conductance of the skin. It is used as an indication of psychological and
      physiological excitation and thus represents an indicator for the individual's stress
      response.

      Electromyograph (EMG) uses surface electrodes to measure the electrical activity of the
      skeletal muscles when they are relaxed and contracted by detecting the combined electrical
      potential generated by the muscle cells. The mean value of the rectified EMG signal of the
      upper trapezius muscle increases during stressful conditions and decreases again during
      relaxation periods.

      Electrocardiogram (ECG) electrodes are used to measure the heart function and further
      calculate the heart rate variability (HRV). HRV is defined as the beat-to-beat changes, the
      interbeat interval, which is the time between two successive R waves. HRV is considered as a
      measure of the interaction between sympathetic and parasympathetic influence on heart rate.
      The activation of the sympathetic branch of the autonomic nervous system increases heart
      rate, while the activation of the parasympathetic branch, primarily mediated by the vagus
      nerve, slows it. These physiological signals provide a reliable measurement of agitation
      (stress).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Perioperative agitation (stress) measurement
time frame: 12 months
description: Perioperative stress will be measured using the BioLink Biofeedback device, which records an electrocardiogram, an electromyogram, skin conductance and respiratory rate. Changes in the different values show how stressed the patient was during the surgeries.
measure: Assessment of pain perception
time frame: 12 months
description: Pain perception of the patients will be assessed during the two cataract surgeries using an visual analogue scale, where 10 means highest pain and 1 is lowest pain.
arm group label: Biofeedback measurement
arm group type: Experimental
description: A Biofeedback measurement will be done during cataract surgery of both eyes
intervention type: Procedure
intervention name: Cataract surgery
description: A biofeedback measurement will be carried out during cataract surgery of both eyes
arm group label: Biofeedback measurement
criteria: 
gender: All
minimum age: 21 Years
maximum age: 105 Years
healthy volunteers: No
last name: John Falasinnu, MD
phone: 01 91021-57559
email: office@viros.at
last name: Katharina Kefer
phone: 01 91021-57564
email: office@viros.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Vienna Institute for Research in Ocular Surgery
investigator full name: Prim. Prof. Dr. Oliver Findl, MBA
investigator title: Principal Investigator
mesh term: Cataract
sharing ipd: Undecided