<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/NCT04428541</url>
  </required_header>
  <id_info>
    <org_study_id>PDU_2020_1</org_study_id>
    <nct_id>NCT04428541</nct_id>
  </id_info>
  <brief_title>Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies</brief_title>
  <acronym>EVEIL</acronym>
  <official_title>Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually&#xD;
      satisfactory postoperative results in visual terms.&#xD;
&#xD;
      However, it is often difficult to choose the right moment to operate. The main difficulty is&#xD;
      that the child's vision is unknown since the child is still in a preverbal age.&#xD;
&#xD;
      The investigators have developed a questionnaire with the aim of quantifying the child's&#xD;
      vision so that the decision is most justified. The items of this questionnaire were&#xD;
      established based on the literature and were submitted to a panel of experts in&#xD;
      ophthalmo-pediatrics. The objective of this study is to determine the internal validity and&#xD;
      as far as possible (since there is no equivalent tool) the external validity of the&#xD;
      questionnaire developed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</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>Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children</measure>
    <time_frame>Inclusion</time_frame>
    <description>Reliability evaluated by Cronbach's alpha coefficient and its 95% confidence interval.&#xD;
unabbreviated scale title : Assessment of Visual Function in Preverbal Children in Bilateral Ocular Pathology&#xD;
Minimum value : 0&#xD;
Maximum value : 18&#xD;
Higher scores mean better outcome</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Eye Diseases</condition>
  <condition>Vision Disorders</condition>
  <arm_group>
    <arm_group_label>Questionnaire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Description : 18 items questionnaire, filled by the parents of the child</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire for visual function assessment of preverbal children</intervention_name>
    <description>18 items questionnaire</description>
    <arm_group_label>Questionnaire</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Common to the three groups:&#xD;
&#xD;
          -  Patient aged 0 to 36 months&#xD;
&#xD;
          -  Diagnosis of known ocular pathology&#xD;
&#xD;
        For patients targeted by the questionnaire:&#xD;
&#xD;
        - Patient with operable bilateral ocular pathology&#xD;
&#xD;
        For negative controls:&#xD;
&#xD;
        - Patient without ocular pathology inducing a decrease in vision&#xD;
&#xD;
        For positive controls:&#xD;
&#xD;
          -  Patient with inoperable bilateral ocular pathology&#xD;
&#xD;
          -  Patient without light perception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with unilateral ocular pathology&#xD;
&#xD;
          -  Verbal patients (able to express themselves through speech)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascal DUREAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation A. de Rothschild</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amélie YAVCHITZ, MD</last_name>
    <phone>(0)148036454</phone>
    <phone_ext>+33</phone_ext>
    <email>ayavchitz@for.paris</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pascal DUREAU, MD</last_name>
    <email>pdureau@for.paris</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fondation A de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal DUREAU, MD</last_name>
      <email>pdureau@for.paris</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eye Diseases</keyword>
  <keyword>Vision Disorders</keyword>
  <keyword>Questionnaire Design</keyword>
  <keyword>Children</keyword>
  <keyword>Infant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision Disorders</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT04428541
org study id: PDU_2020_1
nct id: NCT04428541
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually
      satisfactory postoperative results in visual terms.

      However, it is often difficult to choose the right moment to operate. The main difficulty is
      that the child's vision is unknown since the child is still in a preverbal age.

      The investigators have developed a questionnaire with the aim of quantifying the child's
      vision so that the decision is most justified. The items of this questionnaire were
      established based on the literature and were submitted to a panel of experts in
      ophthalmo-pediatrics. The objective of this study is to determine the internal validity and
      as far as possible (since there is no equivalent tool) the external validity of the
      questionnaire developed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children
time frame: Inclusion
description: Reliability evaluated by Cronbach's alpha coefficient and its 95% confidence interval.
unabbreviated scale title : Assessment of Visual Function in Preverbal Children in Bilateral Ocular Pathology
Minimum value : 0
Maximum value : 18
Higher scores mean better outcome
arm group label: Questionnaire
arm group type: Experimental
description: Description : 18 items questionnaire, filled by the parents of the child
intervention type: Other
intervention name: Questionnaire for visual function assessment of preverbal children
description: 18 items questionnaire
arm group label: Questionnaire
criteria: 
gender: All
minimum age: 0 Months
maximum age: 36 Months
healthy volunteers: No
last name: Pascal DUREAU, MD
role: Principal Investigator
affiliation: Fondation A. de Rothschild
last name: Amélie YAVCHITZ, MD
phone: (0)148036454
phone ext: +33
email: ayavchitz@for.paris
last name: Pascal DUREAU, MD
email: pdureau@for.paris
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Vision Disorders
mesh term: Eye Diseases