<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/NCT03832335</url>
  </required_header>
  <id_info>
    <org_study_id>04127</org_study_id>
    <nct_id>NCT03832335</nct_id>
  </id_info>
  <brief_title>A New Measurement of Anseikonia Tolerance</brief_title>
  <official_title>Can we Measure Aniseikonia Tolerance in a Normal Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glostrup University Hospital, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Population 1:&#xD;
&#xD;
      Measure the effect of size glasses from1-9% on stereopsis&#xD;
&#xD;
      Population 2:&#xD;
&#xD;
      Measure the effect of size glasses from 1-9% on stereopsis in two settings:&#xD;
&#xD;
        -  before and after cataract surgery&#xD;
&#xD;
        -  after dilation of the eye&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Population 1:&#xD;
&#xD;
      21 eye healthy phakic individuals. Measurements: baseline stereopsis and stereopsis after&#xD;
      size glass (1-9%) is added in front of the right eye and in front og the left eye. This&#xD;
      measurement provides details on how much size difference a person can endure without&#xD;
      impairing stereopsis.&#xD;
&#xD;
      Population 2:&#xD;
&#xD;
      11 phakic eye healthy individuals awaiting cataract operation on both eyes. Measurements are&#xD;
      the same as population 1 but this study group is also measured after dilating the eyes. This&#xD;
      is to see if accommodation affects the measurement. A postoperative measurement six weeks&#xD;
      after cataract operation is also performed to examine if cataract operation affects the&#xD;
      measurement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2, 2019</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>Aniseikonia tolerance</measure>
    <time_frame>baseline</time_frame>
    <description>How many percent aniseikonia is tolerated before stereopsis is impaired. Measured by first measuring baseline stereopsis and here after adding aniseikonic (size glass) from 1-9% in front of the right and left eye to measure if stereopsis is impaired. If stereopsis is impaired at 4% sizeglas then aniseikonia tolerance is 4%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Aniseikonia tolerance after surgery</measure>
    <time_frame>six weeks after surgery</time_frame>
    <description>Measurement of aniseikonia tolerance before and after surgery. Measurement: before and after surgery stereopsis is measured, hereafter aniseikonic glasses (size glass) from 1-9% is added in front of the right and left eye to see if stereopsis is impaired. If stereopsis is impaired with 3% aniseikonic glass then the tolerance is 3%. After surgery the measurement is repeated to examine if the aniseikonia tolerance is the same.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">31</enrollment>
  <condition>Aniseikonia</condition>
  <condition>Anisometropia and Aniseikonia</condition>
  <arm_group>
    <arm_group_label>Phakic group</arm_group_label>
    <description>21 eyehealthy individuals examined for baseline stereopsis and impact of aniseikonia on stereopsis. An non-invasive measurement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cataract group</arm_group_label>
    <description>11 patients awaiting cataract surgery on both eyes. Measurement of baseline stereopsis and impact of artificial induced aniseikonia on stereopsis. A non invasive measurement that are repeated after dilatation of the eyes and again six weeks after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Measurement of aniseikonia tolerance</intervention_name>
    <description>Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis</description>
    <arm_group_label>Cataract group</arm_group_label>
    <arm_group_label>Phakic group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        group 1: eyehealthy pahkic individuls group 2: eyehalthy phakic patients awainting cataratc&#xD;
        surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No previous eye history&#xD;
&#xD;
          -  cataract grade &lt;= 1&#xD;
&#xD;
          -  visual acuity above 0.8&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of cooperation&#xD;
&#xD;
          -  amblyopia&#xD;
&#xD;
          -  axial anisometropia&#xD;
&#xD;
          -  ametropia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rigshospitalet-glostrup</name>
      <address>
        <city>Glostrup</city>
        <state>Danmark</state>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Therese Krarup, MD</last_name>
      <phone>+4528577271</phone>
      <email>theresekrarup@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Birgit Sander</last_name>
      <phone>+4538633863</phone>
      <email>bisan@regionh.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Glostrup University Hospital, Copenhagen</investigator_affiliation>
    <investigator_full_name>Therese Krarup</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>Anisometropia</mesh_term>
    <mesh_term>Aniseikonia</mesh_term>
  </condition_browse>
  <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/NCT03832335
org study id: 04127
nct id: NCT03832335
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Population 1:

      Measure the effect of size glasses from1-9% on stereopsis

      Population 2:

      Measure the effect of size glasses from 1-9% on stereopsis in two settings:

        -  before and after cataract surgery

        -  after dilation of the eye
Population 1:

      21 eye healthy phakic individuals. Measurements: baseline stereopsis and stereopsis after
      size glass (1-9%) is added in front of the right eye and in front og the left eye. This
      measurement provides details on how much size difference a person can endure without
      impairing stereopsis.

      Population 2:

      11 phakic eye healthy individuals awaiting cataract operation on both eyes. Measurements are
      the same as population 1 but this study group is also measured after dilating the eyes. This
      is to see if accommodation affects the measurement. A postoperative measurement six weeks
      after cataract operation is also performed to examine if cataract operation affects the
      measurement.
observational model: Cohort
time perspective: Prospective
measure: Aniseikonia tolerance
time frame: baseline
description: How many percent aniseikonia is tolerated before stereopsis is impaired. Measured by first measuring baseline stereopsis and here after adding aniseikonic (size glass) from 1-9% in front of the right and left eye to measure if stereopsis is impaired. If stereopsis is impaired at 4% sizeglas then aniseikonia tolerance is 4%.
measure: Change of Aniseikonia tolerance after surgery
time frame: six weeks after surgery
description: Measurement of aniseikonia tolerance before and after surgery. Measurement: before and after surgery stereopsis is measured, hereafter aniseikonic glasses (size glass) from 1-9% is added in front of the right and left eye to see if stereopsis is impaired. If stereopsis is impaired with 3% aniseikonic glass then the tolerance is 3%. After surgery the measurement is repeated to examine if the aniseikonia tolerance is the same.
arm group label: Phakic group
description: 21 eyehealthy individuals examined for baseline stereopsis and impact of aniseikonia on stereopsis. An non-invasive measurement.
arm group label: Cataract group
description: 11 patients awaiting cataract surgery on both eyes. Measurement of baseline stereopsis and impact of artificial induced aniseikonia on stereopsis. A non invasive measurement that are repeated after dilatation of the eyes and again six weeks after surgery.
intervention type: Diagnostic Test
intervention name: Measurement of aniseikonia tolerance
description: Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis
arm group label: Cataract group
arm group label: Phakic group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Glostrup University Hospital, Copenhagen
investigator full name: Therese Krarup
investigator title: Principal investigator
mesh term: Anisometropia
mesh term: Aniseikonia
sharing ipd: No