xml: <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/NCT06016712</url>
    </required_header>
    <id_info>
      <org_study_id>EK-VP/55l012022</org_study_id>
      <secondary_id>Internal hospital grant</secondary_id>
      <nct_id>NCT06016712</nct_id>
    </id_info>
    <brief_title>The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes</brief_title>
    <acronym>ELIPFHE</acronym>
    <official_title>The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Faculty Hospital Kralovske Vinohrady</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Faculty Hospital Kralovske Vinohrady</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>
        Glaucoma is a multifactorial disease, an important risk factor of which is increased&#xD;
        intraocular pressure. Fluctuations in intraocular pressure are often associated with vaginal&#xD;
        birth, although intraocular pressure during active pushing during stage II has never been&#xD;
        measured.. The study will be conducted on a group of patients with healthy eyes on patients&#xD;
        who have completely fine vision or have a small refractive error and are accustomed to&#xD;
        wearing contact lenses. The measurement of intraocular pressure itself will be carried out&#xD;
        using SENSIMED Triggerfish contact lenses, which measure pressure every 5 minutes for 30s.&#xD;
        This period roughly corresponds to the duration of 1-2 contractions. Inclusion in the study&#xD;
        will be offered to patients in the 35th to 37th week of pregnancy. Prior to measurement&#xD;
        patients will be sent to an eye clinic for a detailed examination of both eyes, which&#xD;
        includes measuring intraocular pressure. Subsequently, pregnancy checks will take place&#xD;
        according to the standard scheme and in the standard scope. At the onset of uterine&#xD;
        contractions, an ophthalmologic consultant will be called, which will measure intraocular&#xD;
        pressure between contractions using the Tonopen device and put on SENSIMED Trigerfish contact&#xD;
        lenses in combination with a local anesthetic. The patient will have these lenses until the&#xD;
        end of the third stage of labor, i.e. 2 hours after the birth, when the lenses are removed.&#xD;
        In the second stage of labor, continuous monitoring by a cardiotocograph will take place.&#xD;
        Subsequently, the obtained data from the cardiotocograph and contact lenses will be evaluated&#xD;
        and compared by a team of ophthalmologists and gynecologists, where the investigators will be&#xD;
        able to assess the individual fluctuations in intraocular pressure depending on the&#xD;
        individual contractions. The aim of the study is to demonstrate or disprove the risks to the&#xD;
        glaucoma patient due to increased intraocular pressure during active pushing in combination&#xD;
        with uterine contraction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Glaucoma is a multifactorial disease, an important risk factor of which is increased&#xD;
        intraocular pressure. Fluctuations in intraocular pressure are often associated with vaginal&#xD;
        birth, although intraocular pressure during active pushing during stage II has never been&#xD;
        measured. The study will be conducted on a group of patients with healthy eyes on patients&#xD;
        who have completely fine vision or have a small refractive error and are accustomed to&#xD;
        wearing contact lenses. The measurement of intraocular pressure itself will be carried out&#xD;
        using SENSIMED Triggerfish contact lenses, which measure pressure every 5 minutes for 30s.&#xD;
        This period roughly corresponds to the duration of 1-2 contractions. Inclusion in the study&#xD;
        will be offered to patients in the 35th to 37th week of pregnancy.Prior to measurement&#xD;
        patients will be sent to an eye clinic for a detailed examination of both eyes, which&#xD;
        includes measuring intraocular pressure. Subsequently, pregnancy checks will take place&#xD;
        according to the standard scheme and in the standard scope. At the onset of uterine&#xD;
        contractions, an ophthalmologic consultant will be called, which will measure intraocular&#xD;
        pressure between contractions using the Tonopen device and put on SENSIMED Trigerfish contact&#xD;
        lenses in combination with a local anesthetic. The patient will have these lenses until the&#xD;
        end of the third stage of labor, i.e. 2 hours after the birth, when the lenses are removed.&#xD;
        In the second stage of labor, continuous monitoring by a cardiotocograph will take place.&#xD;
        Subsequently, the obtained data from the cardiotocograph and contact lenses will be evaluated&#xD;
        and compared by a team of ophthalmologists and gynecologists, where the investigators will be&#xD;
        able to assess the individual fluctuations in intraocular pressure depending on the&#xD;
        individual contractions. The aim of the study is to demonstrate or disprove the risks to the&#xD;
        glaucoma patient due to increased intraocular pressure during active pushing in combination&#xD;
        with uterine contraction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>
      <masking_description>No masking</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Intraocular pressure</measure>
      <time_frame>From start of regular contractions for the length of 24 hours (at least 2 hours after delivery if patient complies about the lenses)</time_frame>
      <description>Investigators will use SENSIMED Triggerfish Lenses - contact lenses used for measuring intraocular pressure. Lenses are sending detailed description of intraocular pressure in regular time range. Measurements are then send to the software which compares all collected data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uterine contractions</measure>
      <time_frame>Continuous CTG will be done during II phase of delivery and at least every 2 hours durins I phase of delivery</time_frame>
      <description>Cardiotocography will be used for measuring regular uterine activity. Tocography will be used for evaluation of uterine activity compared to intraocular pressure</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">9</enrollment>
    <condition>Intraocular Pressure</condition>
    <condition>Delivery</condition>
    <arm_group>
      <arm_group_label>Participant</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SENSIMED Triggerfish lenses will be applied on this Arm and Intraocular pressure during active phase of delivery will be measured</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SENSIMED Triggerfish Eye Lenses</intervention_name>
      <description>Contact lenses used for measuring intraocular pressure.</description>
      <arm_group_label>Participant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  physiological pregnancy&#xD;
  &#xD;
            -  primiparous women&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  multiparous women&#xD;
  &#xD;
            -  pathological pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pavel Studeny, prof, MD, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Fakultni Nemocnice Kralovske Vinohrady</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jan Zapletal, MD</last_name>
      <phone>+420607882602</phone>
      <email>honza.zaple@seznam.cz</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alina Dana Baxant, MD</last_name>
      <phone>+420734395155</phone>
      <email>alinadana.baxant@fnkv.cz</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty Hospital Kralovske Vinohrady</name>
        <address>
          <city>Praha</city>
          <zip>11000</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jan Zapletal, MD</last_name>
        <phone>+420607882602</phone>
        <email>honza.zaple@seznam.cz</email>
      </contact>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Faculty Hospital Kralovske Vinohrady</investigator_affiliation>
      <investigator_full_name>Jan Zapletal</investigator_full_name>
      <investigator_title>Medical Doctor, Department of Obstetrics and Gynecology</investigator_title>
    </responsible_party>
    <keyword>Intraocular pressure</keyword>
    <keyword>delivery</keyword>
    <keyword>pregnancy</keyword>
    <keyword>glaucoma</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016712
  org study id: EK-VP/55l012022
  secondary id: Internal hospital grant
  nct id: NCT06016712
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Glaucoma is a multifactorial disease, an important risk factor of which is increased
        intraocular pressure. Fluctuations in intraocular pressure are often associated with vaginal
        birth, although intraocular pressure during active pushing during stage II has never been
        measured.. The study will be conducted on a group of patients with healthy eyes on patients
        who have completely fine vision or have a small refractive error and are accustomed to
        wearing contact lenses. The measurement of intraocular pressure itself will be carried out
        using SENSIMED Triggerfish contact lenses, which measure pressure every 5 minutes for 30s.
        This period roughly corresponds to the duration of 1-2 contractions. Inclusion in the study
        will be offered to patients in the 35th to 37th week of pregnancy. Prior to measurement
        patients will be sent to an eye clinic for a detailed examination of both eyes, which
        includes measuring intraocular pressure. Subsequently, pregnancy checks will take place
        according to the standard scheme and in the standard scope. At the onset of uterine
        contractions, an ophthalmologic consultant will be called, which will measure intraocular
        pressure between contractions using the Tonopen device and put on SENSIMED Trigerfish contact
        lenses in combination with a local anesthetic. The patient will have these lenses until the
        end of the third stage of labor, i.e. 2 hours after the birth, when the lenses are removed.
        In the second stage of labor, continuous monitoring by a cardiotocograph will take place.
        Subsequently, the obtained data from the cardiotocograph and contact lenses will be evaluated
        and compared by a team of ophthalmologists and gynecologists, where the investigators will be
        able to assess the individual fluctuations in intraocular pressure depending on the
        individual contractions. The aim of the study is to demonstrate or disprove the risks to the
        glaucoma patient due to increased intraocular pressure during active pushing in combination
        with uterine contraction.
  Glaucoma is a multifactorial disease, an important risk factor of which is increased
        intraocular pressure. Fluctuations in intraocular pressure are often associated with vaginal
        birth, although intraocular pressure during active pushing during stage II has never been
        measured. The study will be conducted on a group of patients with healthy eyes on patients
        who have completely fine vision or have a small refractive error and are accustomed to
        wearing contact lenses. The measurement of intraocular pressure itself will be carried out
        using SENSIMED Triggerfish contact lenses, which measure pressure every 5 minutes for 30s.
        This period roughly corresponds to the duration of 1-2 contractions. Inclusion in the study
        will be offered to patients in the 35th to 37th week of pregnancy.Prior to measurement
        patients will be sent to an eye clinic for a detailed examination of both eyes, which
        includes measuring intraocular pressure. Subsequently, pregnancy checks will take place
        according to the standard scheme and in the standard scope. At the onset of uterine
        contractions, an ophthalmologic consultant will be called, which will measure intraocular
        pressure between contractions using the Tonopen device and put on SENSIMED Trigerfish contact
        lenses in combination with a local anesthetic. The patient will have these lenses until the
        end of the third stage of labor, i.e. 2 hours after the birth, when the lenses are removed.
        In the second stage of labor, continuous monitoring by a cardiotocograph will take place.
        Subsequently, the obtained data from the cardiotocograph and contact lenses will be evaluated
        and compared by a team of ophthalmologists and gynecologists, where the investigators will be
        able to assess the individual fluctuations in intraocular pressure depending on the
        individual contractions. The aim of the study is to demonstrate or disprove the risks to the
        glaucoma patient due to increased intraocular pressure during active pushing in combination
        with uterine contraction.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: No masking
  measure: Intraocular pressure
  time frame: From start of regular contractions for the length of 24 hours (at least 2 hours after delivery if patient complies about the lenses)
  description: Investigators will use SENSIMED Triggerfish Lenses - contact lenses used for measuring intraocular pressure. Lenses are sending detailed description of intraocular pressure in regular time range. Measurements are then send to the software which compares all collected data.
  measure: Uterine contractions
  time frame: Continuous CTG will be done during II phase of delivery and at least every 2 hours durins I phase of delivery
  description: Cardiotocography will be used for measuring regular uterine activity. Tocography will be used for evaluation of uterine activity compared to intraocular pressure
  arm group label: Participant
  arm group type: Experimental
  description: SENSIMED Triggerfish lenses will be applied on this Arm and Intraocular pressure during active phase of delivery will be measured
  intervention type: Device
  intervention name: SENSIMED Triggerfish Eye Lenses
  description: Contact lenses used for measuring intraocular pressure.
  arm group label: Participant
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pavel Studeny, prof, MD, Ph.D.
  role: Study Chair
  affiliation: Fakultni Nemocnice Kralovske Vinohrady
  last name: Jan Zapletal, MD
  phone: +420607882602
  email: honza.zaple@seznam.cz
  last name: Alina Dana Baxant, MD
  phone: +420734395155
  email: alinadana.baxant@fnkv.cz
  facility: 
  status: Recruiting
  contact: 
  country: Czechia
  responsible party type: Principal Investigator
  investigator affiliation: Faculty Hospital Kralovske Vinohrady
  investigator full name: Jan Zapletal
  investigator title: Medical Doctor, Department of Obstetrics and Gynecology
  sharing ipd: Undecided