<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/NCT04497896</url>
  </required_header>
  <id_info>
    <org_study_id>17300438</org_study_id>
    <nct_id>NCT04497896</nct_id>
  </id_info>
  <brief_title>Playtime Open Globe Injuries in Children</brief_title>
  <official_title>Epidemiology, Aetiologies, and Complications of Playtime Open-globe Injuries in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      This study investigated the epidemiology, aetiologies, and complications of playtime&#xD;
      open-globe injuries in children at the Assiut University Hospital, Egypt, between January to&#xD;
      July 2016.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study was conducted at the Department of Ophthalmology, Assiut University&#xD;
      Hospital, which is the largest tertiary referral hospital in Upper Egypt and provides 24-hour&#xD;
      ophthalmic emergency services for six governorates. The study included all children (age ≤18&#xD;
      years) admitted with open-globe injuries that occurred during playtime over a 6-month study&#xD;
      period. Demographic information (age and sex), the site and mechanism of injury, the site of&#xD;
      ocular laceration (corneal, scleral or corneoscleral) and associated complications were&#xD;
      recorded and analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity (in Decimal using Snellen chart) after repair of open globe injury</measure>
    <time_frame>1 day</time_frame>
    <description>measurement of corrected distant visual acuity after wound repair.</description>
  </primary_outcome>
  <enrollment type="Actual">81</enrollment>
  <condition>Eye Trauma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Repair of open globe injury</intervention_name>
    <description>repair of corneal, corneoscleral, or scleral wounds</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all children (age ≤18 years) admitted to Assiut university hospital with open-globe&#xD;
        injuries that occurred during playtime over a 6-month study period (January-July 2016).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all children (age ≤18 years) admitted with open-globe injuries that occurred during&#xD;
             playtime over a 6-month study period (January-July 2016).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open globe injuries in patients olader than 18 years.&#xD;
&#xD;
          -  Closed globe injuries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Khaled Abdelazeem</investigator_full_name>
    <investigator_title>Associate professor of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eye Injuries</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/NCT04497896
org study id: 17300438
nct id: NCT04497896
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigated the epidemiology, aetiologies, and complications of playtime
      open-globe injuries in children at the Assiut University Hospital, Egypt, between January to
      July 2016.
This prospective study was conducted at the Department of Ophthalmology, Assiut University
      Hospital, which is the largest tertiary referral hospital in Upper Egypt and provides 24-hour
      ophthalmic emergency services for six governorates. The study included all children (age ≤18
      years) admitted with open-globe injuries that occurred during playtime over a 6-month study
      period. Demographic information (age and sex), the site and mechanism of injury, the site of
      ocular laceration (corneal, scleral or corneoscleral) and associated complications were
      recorded and analysed.
observational model: Other
time perspective: Prospective
measure: Visual acuity (in Decimal using Snellen chart) after repair of open globe injury
time frame: 1 day
description: measurement of corrected distant visual acuity after wound repair.
intervention type: Other
intervention name: Repair of open globe injury
description: repair of corneal, corneoscleral, or scleral wounds
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Khaled Abdelazeem
investigator title: Associate professor of Ophthalmology
mesh term: Eye Injuries
sharing ipd: No