<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/NCT02253017</url>
  </required_header>
  <id_info>
    <org_study_id>2014-06-13</org_study_id>
    <nct_id>NCT02253017</nct_id>
  </id_info>
  <brief_title>Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery</brief_title>
  <acronym>EP3C</acronym>
  <official_title>Assessment Practices Registry in Congenital Cataract Surgery and Infantile</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to assess the therapeutic strategies in the&#xD;
      treatment of pediatric cataracts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Technical progress and recently described potential issues have recently challenged the&#xD;
      surgical treatment of pediatric cataracts. Many questions remain unsolved: primary vs&#xD;
      secondary implantation, nature of the implant used. The aim of this study is to establish a&#xD;
      systematic prospective register of all cataracts operated on in a tertiary pediatric centre&#xD;
      in order to help answering these questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Anticipated">September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Assessment practices in Pediatric Cataract Surgery.</measure>
    <time_frame>8-10 months,</time_frame>
    <description>Rating of efficacy of surgery depending on the implementation or not of a primary location&#xD;
Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal)&#xD;
Evaluation of effectiveness of surgery based on age (&lt;8 weeks of age for unilateral surgery and &lt;11 weeks of life for bilateral surgeries)&#xD;
To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment practices in Pediatric Cataract Surgery.</measure>
    <time_frame>3 years</time_frame>
    <description>Rating of efficacy of surgery depending on the implementation or not of a primary location&#xD;
Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal)&#xD;
Evaluation of effectiveness of surgery based on age (&lt;8 weeks of age for unilateral surgery and &lt;11 weeks of life for bilateral surgeries)&#xD;
To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment practices in Pediatric Cataract Surgery.</measure>
    <time_frame>5 years</time_frame>
    <description>Rating of efficacy of surgery depending on the implementation or not of a primary location&#xD;
Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal)&#xD;
Evaluation of effectiveness of surgery based on age (&lt;8 weeks of age for unilateral surgery and &lt;11 weeks of life for bilateral surgeries)&#xD;
To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment practices in Pediatric Cataract Surgery.</measure>
    <time_frame>8 years (or 6 months after surgery if the child is carried out after 8 years )</time_frame>
    <description>Rating of efficacy of surgery depending on the implementation or not of a primary location&#xD;
Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal)&#xD;
Evaluation of effectiveness of surgery based on age (&lt;8 weeks of age for unilateral surgery and &lt;11 weeks of life for bilateral surgeries)&#xD;
To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of surgery and surgical procedures</measure>
    <time_frame>8-10 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of surgery and surgical procedures</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of surgery and surgical procedures</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of surgery and surgical procedures</measure>
    <time_frame>8 years (or 6 months after surgery if the child is carried out after 8 years).</time_frame>
    <description>8 years (or 6 months after surgery if the child is carried out after 8 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of implant</measure>
    <time_frame>8-10 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of implant</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of implant</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of implant</measure>
    <time_frame>8 years (or 6 months after surgery if the child is carried out after 8 years).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age at implantation</measure>
    <time_frame>8-10 months,</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age at implantation</measure>
    <time_frame>3 years,</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age at implantation</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age at implantation</measure>
    <time_frame>8 years (or 6 months after surgery if the child is carried out after 8 years).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance visual acuity</measure>
    <time_frame>age of 8 years and 6 months after surgery if the child is carried out after the age of 8.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Children operated on for cataract</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Children operated on for cataract</intervention_name>
    <description>Compilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years</description>
    <arm_group_label>Children operated on for cataract</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        ophthalmology department, Necker hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child cataract surgery from 1 September 2014 in the Department of Ophthalmology,&#xD;
             University Hospital Necker-Enfants Malades&#xD;
&#xD;
          -  Children aged between 0 and 17 years&#xD;
&#xD;
          -  Child with unilateral or bilateral cataract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child with bilateral cataract, one eye having previously been operated in another&#xD;
             center.&#xD;
&#xD;
          -  Children whose parents have notified the doctor their refusal of data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthieu Robert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris)</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Therapeutic strategies</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Cataract</keyword>
  <keyword>Surgery</keyword>
  <keyword>Intra-ocular lens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT02253017
org study id: 2014-06-13
nct id: NCT02253017
lead sponsor: 
has dmc: No
The purpose of this observational study is to assess the therapeutic strategies in the
      treatment of pediatric cataracts.
Technical progress and recently described potential issues have recently challenged the
      surgical treatment of pediatric cataracts. Many questions remain unsolved: primary vs
      secondary implantation, nature of the implant used. The aim of this study is to establish a
      systematic prospective register of all cataracts operated on in a tertiary pediatric centre
      in order to help answering these questions.
observational model: Cohort
time perspective: Prospective
measure: Assessment practices in Pediatric Cataract Surgery.
time frame: 8-10 months,
description: Rating of efficacy of surgery depending on the implementation or not of a primary location
Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal)
Evaluation of effectiveness of surgery based on age (<8 weeks of age for unilateral surgery and <11 weeks of life for bilateral surgeries)
To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary
measure: Assessment practices in Pediatric Cataract Surgery.
time frame: 3 years
description: Rating of efficacy of surgery depending on the implementation or not of a primary location
Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal)
Evaluation of effectiveness of surgery based on age (<8 weeks of age for unilateral surgery and <11 weeks of life for bilateral surgeries)
To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary
measure: Assessment practices in Pediatric Cataract Surgery.
time frame: 5 years
description: Rating of efficacy of surgery depending on the implementation or not of a primary location
Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal)
Evaluation of effectiveness of surgery based on age (<8 weeks of age for unilateral surgery and <11 weeks of life for bilateral surgeries)
To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary
measure: Assessment practices in Pediatric Cataract Surgery.
time frame: 8 years (or 6 months after surgery if the child is carried out after 8 years )
description: Rating of efficacy of surgery depending on the implementation or not of a primary location
Evaluate the effectiveness of the implementation based on the type of implant (monofocal or multifocal)
Evaluation of effectiveness of surgery based on age (<8 weeks of age for unilateral surgery and <11 weeks of life for bilateral surgeries)
To assess the frequency of adverse events, particularly glaucoma depending on the occurrence or non-implementation of a primary
measure: Type of surgery and surgical procedures
time frame: 8-10 months
measure: Type of surgery and surgical procedures
time frame: 3 years
measure: Type of surgery and surgical procedures
time frame: 5 years
measure: Type of surgery and surgical procedures
time frame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
description: 8 years (or 6 months after surgery if the child is carried out after 8 years).
measure: Type of implant
time frame: 8-10 months
measure: Type of implant
time frame: 3 years
measure: Type of implant
time frame: 5 years
measure: Type of implant
time frame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
measure: Age at implantation
time frame: 8-10 months,
measure: Age at implantation
time frame: 3 years,
measure: Age at implantation
time frame: 5 years
measure: Age at implantation
time frame: 8 years (or 6 months after surgery if the child is carried out after 8 years).
measure: Distance visual acuity
time frame: age of 8 years and 6 months after surgery if the child is carried out after the age of 8.
arm group label: Children operated on for cataract
intervention type: Other
intervention name: Children operated on for cataract
description: Compilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years
arm group label: Children operated on for cataract
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 17 Years
healthy volunteers: No
last name: Matthieu Robert, MD
role: Principal Investigator
affiliation: Hôpital Necker - Enfants Malades, Assistance Publique-Hôpitaux de Paris, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Cataract