<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/NCT04433689</url>
  </required_header>
  <id_info>
    <org_study_id>CorvisPreg</org_study_id>
    <nct_id>NCT04433689</nct_id>
  </id_info>
  <brief_title>Corneal Biomechanics During Pregnancy</brief_title>
  <acronym>CorvisPreg</acronym>
  <official_title>Change in Corneal Biomechanics During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      It is known that intraocular pressure changes during pregnancy. Collagen structure changes&#xD;
      during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and,&#xD;
      thus, ultimately to enable delivery of a child. The cornea consists of highly structured&#xD;
      collagen fibers. Hence, it seams logically that corneal biomechanics also change during&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is known that intraocular pressure changes during pregnancy. Collagen structure changes&#xD;
      during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and,&#xD;
      thus, ultimately to enable delivery of a child. The cornea consists of highly structured&#xD;
      collagen fibers. Hence, it seams logically that corneal biomechanics also change during&#xD;
      pregnancy.&#xD;
&#xD;
      Measurement of intraocular pressure is highly dependant on corneal properties. With the&#xD;
      Corvis ST device by Ocular Inc. it is possible to measure intraocular pressure and&#xD;
      investigated corneal biomechanics. The aim of this study is therefore to compare corneal&#xD;
      biomechanical properties during the third trimester with corneal biomechanical properties at&#xD;
      3 months after delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Deformation Amplitude</measure>
    <time_frame>at 3 month post delivery compared to during third trimester</time_frame>
    <description>Change in Deformation Amplitude (in millimeters) at 3 month post delivery compared to during third trimester will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Applanation Length</measure>
    <time_frame>at 3 month post delivery compared to during third trimester of the pregnancy</time_frame>
    <description>Change in Applanation Length (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Corneal Velocity</measure>
    <time_frame>at 3 month post delivery compared to during third trimester of the pregnancy</time_frame>
    <description>Change in Corneal Velocity (in meters/second) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in corneal thickness</measure>
    <time_frame>at 3 month post delivery compared to during third trimester of the pregnancy</time_frame>
    <description>Change in corneal thickness (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Intraocular pressure</measure>
    <time_frame>at 3 month post delivery compared to during third trimester of the pregnancy</time_frame>
    <description>Change in intraocular pressure (in millimeters of mercury, mmHg) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>Pregnant woman, age 18 to 38 yo, with uncomplicated singleton pregnancy and no ocular diseases.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-Contact measurement of corneal properties</intervention_name>
    <description>Corneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc.</description>
    <arm_group_label>Pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        healthy pregnant women with uncomplicated singleton pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  females&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  age 18 to 38 yo&#xD;
&#xD;
          -  uncomplicated singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any history of ocular disease or surgery other than conjunctivitis, especially no&#xD;
             history of glaucoma or corneal disease&#xD;
&#xD;
          -  systemic diseases, i.e. diabetes, hypertension, collagenase&#xD;
&#xD;
          -  current contact lens wear&#xD;
&#xD;
          -  before pregnancy taking any systemic or ocular medications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Toeteberg-Harms, MD, FEBO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Dpt. of Ophthalmology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marc o Toeteberg-Harms, MD, FEBO</last_name>
    <phone>+41442551111</phone>
    <phone_ext>+41442551111</phone_ext>
    <email>marc.toeteberg@usz.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Belgin o Özsoy, MD</last_name>
    <phone>+41442551111</phone>
    <phone_ext>+41442551111</phone_ext>
    <email>belgin.oezsoy@usz.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Ophthalmology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Toeteberg-Harms, MD, FEBO</last_name>
      <phone>+41 44 255 - 1111</phone>
      <phone_ext>+41442558794</phone_ext>
      <email>marc.toeteberg@usz.ch</email>
    </contact>
    <contact_backup>
      <last_name>Özsoy Belgin, MD</last_name>
      <phone>+41442558794</phone>
      <phone_ext>+41442558794</phone_ext>
      <email>belgin.oezsoy@usz.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Marc Toeteberg-Harms, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>corneal biomechanical properties</keyword>
  <keyword>intraocular pressure</keyword>
  <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/NCT04433689
org study id: CorvisPreg
nct id: NCT04433689
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is known that intraocular pressure changes during pregnancy. Collagen structure changes
      during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and,
      thus, ultimately to enable delivery of a child. The cornea consists of highly structured
      collagen fibers. Hence, it seams logically that corneal biomechanics also change during
      pregnancy.
It is known that intraocular pressure changes during pregnancy. Collagen structure changes
      during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and,
      thus, ultimately to enable delivery of a child. The cornea consists of highly structured
      collagen fibers. Hence, it seams logically that corneal biomechanics also change during
      pregnancy.

      Measurement of intraocular pressure is highly dependant on corneal properties. With the
      Corvis ST device by Ocular Inc. it is possible to measure intraocular pressure and
      investigated corneal biomechanics. The aim of this study is therefore to compare corneal
      biomechanical properties during the third trimester with corneal biomechanical properties at
      3 months after delivery.
observational model: Cohort
time perspective: Prospective
measure: Change in Deformation Amplitude
time frame: at 3 month post delivery compared to during third trimester
description: Change in Deformation Amplitude (in millimeters) at 3 month post delivery compared to during third trimester will be assessed.
measure: Change in Applanation Length
time frame: at 3 month post delivery compared to during third trimester of the pregnancy
description: Change in Applanation Length (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.
measure: Change in Corneal Velocity
time frame: at 3 month post delivery compared to during third trimester of the pregnancy
description: Change in Corneal Velocity (in meters/second) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.
measure: Change in corneal thickness
time frame: at 3 month post delivery compared to during third trimester of the pregnancy
description: Change in corneal thickness (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.
measure: Change in Intraocular pressure
time frame: at 3 month post delivery compared to during third trimester of the pregnancy
description: Change in intraocular pressure (in millimeters of mercury, mmHg) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.
arm group label: Pregnant women
description: Pregnant woman, age 18 to 38 yo, with uncomplicated singleton pregnancy and no ocular diseases.
intervention type: Device
intervention name: Non-Contact measurement of corneal properties
description: Corneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc.
arm group label: Pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marc Toeteberg-Harms, MD, FEBO
role: Principal Investigator
affiliation: University Hospital Zurich, Dpt. of Ophthalmology
last name: Marc o Toeteberg-Harms, MD, FEBO
phone: +41442551111
phone ext: +41442551111
email: marc.toeteberg@usz.ch
last name: Belgin o Özsoy, MD
phone: +41442551111
phone ext: +41442551111
email: belgin.oezsoy@usz.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No