<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/NCT04456556</url>
  </required_header>
  <id_info>
    <org_study_id>ocular infection in covid19</org_study_id>
    <nct_id>NCT04456556</nct_id>
  </id_info>
  <brief_title>Combined Endophthalmitis and Orbital Cellulitis in Patients With Novel Coronavirus Disease (COVID-19)</brief_title>
  <official_title>Combined Endophthalmitis and Orbital Cellulitis in Patients With Novel Coronavirus Disease (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</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>
      To report on cases presented with combined endophthalmitis and orbital cellulitis as a first&#xD;
      presentation of covid-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This observation case series study included 5 patients referred to the Ophthalmology&#xD;
      Department, Minia University with severe ophthalmic manifestations in the form of combined&#xD;
      endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according&#xD;
      to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the&#xD;
      novel Corona virus. In addition to the Corona work-up, all patients were subjected to full&#xD;
      ophthalmological evaluation, ocular ultrasound and orbital CT examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Combined Endophthalmitis and Orbital Cellulitis in patients with Novel Coronavirus Disease (COVID-19)</measure>
    <time_frame>baseline</time_frame>
    <description>highlight the occurrence of combined endophthalmitis and orbital cellulitis in patients with novel Coronavirus Disease (COVID-19)</description>
  </primary_outcome>
  <enrollment type="Actual">5</enrollment>
  <condition>Endophthalmitis and Orbital Cellulitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        5 patients referred to the Ophthalmology Department, Minia University with severe&#xD;
        ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis.&#xD;
        On doing the work-up of covid-19 infection according to the recommendations of Egyptian&#xD;
        Ministry of Health, patients proved to be infected by the novel Corona virus.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with endophthalmitis and orbital cellulitis with covid-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without endophthalmitis and orbital cellulitis.&#xD;
&#xD;
          -  Patients with endophthalmitis and orbital cellulitis not having covid-19 infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Minia university Hospital</name>
      <address>
        <city>Minya</city>
        <state>Minia</state>
        <zip>61519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Chen L, Liu M, Zhang Z, Qiao K, Huang T, Chen M, Xin N, Huang Z, Liu L, Zhang G, Wang J. Ocular manifestations of a hospitalised patient with confirmed 2019 novel coronavirus disease. Br J Ophthalmol. 2020 Jun;104(6):748-751. doi: 10.1136/bjophthalmol-2020-316304. Epub 2020 Apr 7.</citation>
    <PMID>32265202</PMID>
  </reference>
  <reference>
    <citation>Turbin RE, Wawrzusin PJ, Sakla NM, Traba CM, Wong KG, Mirani N, Eloy JA, Nimchinsky EA. Orbital cellulitis, sinusitis and intracranial abnormalities in two adolescents with COVID-19. Orbit. 2020 Aug;39(4):305-310. doi: 10.1080/01676830.2020.1768560. Epub 2020 May 18.</citation>
    <PMID>32419568</PMID>
  </reference>
  <reference>
    <citation>Elshafei AMK, Sayed MF, Abdallah RMA. Clinical profile and outcomes of management of orbital cellulitis in Upper Egypt. J Ophthalmic Inflamm Infect. 2017 Dec;7(1):8. doi: 10.1186/s12348-017-0126-3. Epub 2017 Mar 9.</citation>
    <PMID>28275981</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Mohamed Farouk Sayed Othman Abelkader</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>endophthalmitis</keyword>
  <keyword>orbital cellulitis</keyword>
  <keyword>covid-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Cellulitis</mesh_term>
    <mesh_term>Endophthalmitis</mesh_term>
    <mesh_term>Orbital Cellulitis</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/NCT04456556
org study id: ocular infection in covid19
nct id: NCT04456556
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To report on cases presented with combined endophthalmitis and orbital cellulitis as a first
      presentation of covid-19 infection.
This observation case series study included 5 patients referred to the Ophthalmology
      Department, Minia University with severe ophthalmic manifestations in the form of combined
      endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according
      to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the
      novel Corona virus. In addition to the Corona work-up, all patients were subjected to full
      ophthalmological evaluation, ocular ultrasound and orbital CT examination.
observational model: Case-Only
time perspective: Retrospective
measure: Combined Endophthalmitis and Orbital Cellulitis in patients with Novel Coronavirus Disease (COVID-19)
time frame: baseline
description: highlight the occurrence of combined endophthalmitis and orbital cellulitis in patients with novel Coronavirus Disease (COVID-19)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
citation: Chen L, Liu M, Zhang Z, Qiao K, Huang T, Chen M, Xin N, Huang Z, Liu L, Zhang G, Wang J. Ocular manifestations of a hospitalised patient with confirmed 2019 novel coronavirus disease. Br J Ophthalmol. 2020 Jun;104(6):748-751. doi: 10.1136/bjophthalmol-2020-316304. Epub 2020 Apr 7.
PMID: 32265202
citation: Turbin RE, Wawrzusin PJ, Sakla NM, Traba CM, Wong KG, Mirani N, Eloy JA, Nimchinsky EA. Orbital cellulitis, sinusitis and intracranial abnormalities in two adolescents with COVID-19. Orbit. 2020 Aug;39(4):305-310. doi: 10.1080/01676830.2020.1768560. Epub 2020 May 18.
PMID: 32419568
citation: Elshafei AMK, Sayed MF, Abdallah RMA. Clinical profile and outcomes of management of orbital cellulitis in Upper Egypt. J Ophthalmic Inflamm Infect. 2017 Dec;7(1):8. doi: 10.1186/s12348-017-0126-3. Epub 2017 Mar 9.
PMID: 28275981
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Mohamed Farouk Sayed Othman Abelkader
investigator title: associate professor
mesh term: COVID-19
mesh term: Cellulitis
mesh term: Endophthalmitis
mesh term: Orbital Cellulitis