xml: <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/NCT05966545</url>
    </required_header>
    <id_info>
      <org_study_id>ZU-IRB#9040/24-10-24</org_study_id>
      <nct_id>NCT05966545</nct_id>
    </id_info>
    <brief_title>Extraction Routes of Intraocular Foreign Body</brief_title>
    <acronym>IOFB</acronym>
    <official_title>Outcomes of Retained Posterior Segment Intraocular Foreign Body Extraction With Coexisting Cataract Via The Limbus or The Pars Plana Route</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zagazig University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zagazig 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>
        Intra ocular foreign body removal is indicated to avoid further many complications such as&#xD;
        retinal detachment, endophthalmitis. The surgical approach for a posterior segment IOFB is&#xD;
        pars plana vitrectomy and its extraction either through the pars plana. our study is to&#xD;
        compare limbal route versus pars plana route for extraction of posterior segment IOFB&#xD;
        associated with cataract as regard to safety and complications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Penetrating ocular injuries with retained posterior segment intraocular foreign body (IOFB)&#xD;
        are relatively common and account for 17% to 41% of ocular injuries.&#xD;
  &#xD;
        Intra ocular foreign body removal is indicated to avoid further many complications such as&#xD;
        retinal detachment, endophthalmitis, retinal toxicity (secondary to chalcosis, siderosis) and&#xD;
        sympathetic ophthalmia.&#xD;
  &#xD;
        The surgical approach for a posterior segment IOFB is pars plana vitrectomy (PPV) and its&#xD;
        extraction either through the pars plana or the limbus.&#xD;
  &#xD;
        PPV and IOFB extraction through sclerotomy is the most commonly used approach. Most commonly&#xD;
        retained posterior segment intra ocular foreign bodies (IOFB) are removed after enlarging one&#xD;
        of the sclerotomy ports during pars plana vitrectomy. Intra operative complications reported&#xD;
        during IOFB extraction were hypotony, vitreous hemorrhage, incarceration of the retina in the&#xD;
        wound, IOFB slippage. Reported post-operative complications were glaucoma and retinal&#xD;
        detachment. Incidence of post-operative RD was reported to range from 22% to 79% with poor&#xD;
        visual outcomes in most cases PPV and IOFB extraction through the limbal route is an&#xD;
        alternative approach to remove IOFB. Complications reported were less frequent and include&#xD;
        microscopic hyphema and vitreous hemorrhage. The incidence of post-operative retinal&#xD;
        detachment after IOFB extraction through limbus was reported to range from 7.15% to 27.7 %&#xD;
        The limbal route for retained posterior segment IOFB extraction can offer the following&#xD;
        advantages: it allows visually controlled delivery of the IOFB from the posterior pole to the&#xD;
        limbal exit and it has no relation to the vitreous base, thus minimizing the risk of creating&#xD;
        a peripheral retinal break during extraction of intraocular foreign body, in contrast to the&#xD;
        hidden part behind the iris when using the pars plana route.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>post-operative retinal detachment</measure>
      <time_frame>1, 3 and 6 months</time_frame>
      <description>comparing incidence of post-operative retinal detachment after intraocular foreign body extraction via limbus versus pars plana route.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>post-operative best corrected visual acuity</measure>
      <time_frame>1, 3 and 6 months</time_frame>
      <description>report post-operative best corrected visual acuity after intraocular foreign body extraction via limbus versus pars plana route.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>associated intra operative and post-operative complications.</measure>
      <time_frame>1, 3 and 6 months</time_frame>
      <description>report associated intra operative and post-operative complications</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Intraocular Foreign Body</condition>
    <arm_group>
      <arm_group_label>intraocular foreign body extraction via the limbus</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>pars plana vitrectomy and intraocular foreign body removal via the limbus, after complete removal of adhesions around intraocular foreign body, then the foreign body will be grasped using basket forceps, and it will be brought to anterior chamber and then removed through limbal incision. The external earth magnet will be applied close to the limbus to prevent its slippage from the forceps if needed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>intraocular foreign body extraction via the pars plana route</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>pars plana vitrectomy and intraocular foreign body removal via pars plana route, after complete removal of adhesions around intraocular foreign body, then IOFB will be grasped using basket forceps, and while the IOFB removed through the sclerotomy an external earth magnet will be applied close to the sclerotomy after enlargement the sclerotomy to prevent its slippage from the forceps and falling down onto the posterior pole if needed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>pars plana vitrectomy and intraocular foreign body removal</intervention_name>
      <description>removal of vitreous body and attachment to foreign body then extraction of foreign body</description>
      <arm_group_label>intraocular foreign body extraction via the limbus</arm_group_label>
      <arm_group_label>intraocular foreign body extraction via the pars plana route</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eyes with retained posterior segment intraocular foreign body associated with&#xD;
               crystalline lens injury.&#xD;
  &#xD;
            -  Eyes with retained posterior segment intraocular foreign body associated with&#xD;
               coexisting cataract.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Eyes with pre-operative retinal detachment&#xD;
  &#xD;
            -  Eyes with retained posterior segment IOFB with clear lens.&#xD;
  &#xD;
            -  Anterior segment IOFBs&#xD;
  &#xD;
            -  Severely damaged eyes with an initial visual acuity of no light perception where&#xD;
               enucleation is the primary treatment&#xD;
  &#xD;
            -  Patients with severely traumatized cornea which can affect visualization during&#xD;
               vitrectomy.&#xD;
  &#xD;
            -  Pseudophakic eyes.&#xD;
  &#xD;
            -  Eyes with endophthalmitis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>sherif A. Dabour, MD</last_name>
      <role>Study Director</role>
      <affiliation>Zagazig University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmad S. Khalil, MD</last_name>
      <role>Study Director</role>
      <affiliation>Zagazig University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abbas A. Ali Hashem, MSc</last_name>
      <phone>01066227749</phone>
      <phone_ext>002</phone_ext>
      <email>aaahashem@medicine.zu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wael M. El haig, MD</last_name>
      <phone>01222155744</phone>
      <phone_ext>002</phone_ext>
      <email>waelmohamed@medicine.zu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>faculty of medicine, Zagazig university</name>
        <address>
          <city>Zagazig</city>
          <state>Sharkia</state>
          <zip>44511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abbas A. Ali Hashem, Msc</last_name>
        <phone>01066227749</phone>
        <phone_ext>002</phone_ext>
        <email>aaahashem@medicine.zu.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>Wael M. EL Haig, MD</last_name>
        <phone>01222155744</phone>
        <phone_ext>002</phone_ext>
        <email>waelmohamed@medicine.zu.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Demircan N, Soylu M, Yagmur M, Akkaya H, Ozcan AA, Varinli I. Pars plana vitrectomy in ocular injury with intraocular foreign body. J Trauma. 2005 Nov;59(5):1216-8. doi: 10.1097/01.ta.0000196438.48182.ff.</citation>
      <PMID>16385302</PMID>
    </reference>
    <reference>
      <citation>Loporchio D, Mukkamala L, Gorukanti K, Zarbin M, Langer P, Bhagat N. Intraocular foreign bodies: A review. Surv Ophthalmol. 2016 Sep-Oct;61(5):582-96. doi: 10.1016/j.survophthal.2016.03.005. Epub 2016 Mar 17.</citation>
      <PMID>26994871</PMID>
    </reference>
    <reference>
      <citation>Wani VB, Al-Ajmi M, Thalib L, Azad RV, Abul M, Al-Ghanim M, Sabti K. Vitrectomy for posterior segment intraocular foreign bodies: visual results and prognostic factors. Retina. 2003 Oct;23(5):654-60. doi: 10.1097/00006982-200310000-00008.</citation>
      <PMID>14574250</PMID>
    </reference>
    <reference>
      <citation>Wickham L, Xing W, Bunce C, Sullivan P. Outcomes of surgery for posterior segment intraocular foreign bodies--a retrospective review of 17 years of clinical experience. Graefes Arch Clin Exp Ophthalmol. 2006 Dec;244(12):1620-6. doi: 10.1007/s00417-006-0359-6.</citation>
      <PMID>16788826</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zagazig University</investigator_affiliation>
      <investigator_full_name>Abbas Abomesslam Ali Hashem</investigator_full_name>
      <investigator_title>assistant lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Eye Foreign Bodies</mesh_term>
      <mesh_term>Foreign Bodies</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966545
  org study id: ZU-IRB#9040/24-10-24
  nct id: NCT05966545
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Intra ocular foreign body removal is indicated to avoid further many complications such as
        retinal detachment, endophthalmitis. The surgical approach for a posterior segment IOFB is
        pars plana vitrectomy and its extraction either through the pars plana. our study is to
        compare limbal route versus pars plana route for extraction of posterior segment IOFB
        associated with cataract as regard to safety and complications.
  Penetrating ocular injuries with retained posterior segment intraocular foreign body (IOFB)
        are relatively common and account for 17% to 41% of ocular injuries.
  
        Intra ocular foreign body removal is indicated to avoid further many complications such as
        retinal detachment, endophthalmitis, retinal toxicity (secondary to chalcosis, siderosis) and
        sympathetic ophthalmia.
  
        The surgical approach for a posterior segment IOFB is pars plana vitrectomy (PPV) and its
        extraction either through the pars plana or the limbus.
  
        PPV and IOFB extraction through sclerotomy is the most commonly used approach. Most commonly
        retained posterior segment intra ocular foreign bodies (IOFB) are removed after enlarging one
        of the sclerotomy ports during pars plana vitrectomy. Intra operative complications reported
        during IOFB extraction were hypotony, vitreous hemorrhage, incarceration of the retina in the
        wound, IOFB slippage. Reported post-operative complications were glaucoma and retinal
        detachment. Incidence of post-operative RD was reported to range from 22% to 79% with poor
        visual outcomes in most cases PPV and IOFB extraction through the limbal route is an
        alternative approach to remove IOFB. Complications reported were less frequent and include
        microscopic hyphema and vitreous hemorrhage. The incidence of post-operative retinal
        detachment after IOFB extraction through limbus was reported to range from 7.15% to 27.7 %
        The limbal route for retained posterior segment IOFB extraction can offer the following
        advantages: it allows visually controlled delivery of the IOFB from the posterior pole to the
        limbal exit and it has no relation to the vitreous base, thus minimizing the risk of creating
        a peripheral retinal break during extraction of intraocular foreign body, in contrast to the
        hidden part behind the iris when using the pars plana route.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: post-operative retinal detachment
  time frame: 1, 3 and 6 months
  description: comparing incidence of post-operative retinal detachment after intraocular foreign body extraction via limbus versus pars plana route.
  measure: post-operative best corrected visual acuity
  time frame: 1, 3 and 6 months
  description: report post-operative best corrected visual acuity after intraocular foreign body extraction via limbus versus pars plana route.
  measure: associated intra operative and post-operative complications.
  time frame: 1, 3 and 6 months
  description: report associated intra operative and post-operative complications
  arm group label: intraocular foreign body extraction via the limbus
  arm group type: Active Comparator
  description: pars plana vitrectomy and intraocular foreign body removal via the limbus, after complete removal of adhesions around intraocular foreign body, then the foreign body will be grasped using basket forceps, and it will be brought to anterior chamber and then removed through limbal incision. The external earth magnet will be applied close to the limbus to prevent its slippage from the forceps if needed.
  arm group label: intraocular foreign body extraction via the pars plana route
  arm group type: Active Comparator
  description: pars plana vitrectomy and intraocular foreign body removal via pars plana route, after complete removal of adhesions around intraocular foreign body, then IOFB will be grasped using basket forceps, and while the IOFB removed through the sclerotomy an external earth magnet will be applied close to the sclerotomy after enlargement the sclerotomy to prevent its slippage from the forceps and falling down onto the posterior pole if needed.
  intervention type: Procedure
  intervention name: pars plana vitrectomy and intraocular foreign body removal
  description: removal of vitreous body and attachment to foreign body then extraction of foreign body
  arm group label: intraocular foreign body extraction via the limbus
  arm group label: intraocular foreign body extraction via the pars plana route
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: sherif A. Dabour, MD
  role: Study Director
  affiliation: Zagazig University
  last name: Ahmad S. Khalil, MD
  role: Study Director
  affiliation: Zagazig University
  last name: Abbas A. Ali Hashem, MSc
  phone: 01066227749
  phone ext: 002
  email: aaahashem@medicine.zu.edu.eg
  last name: Wael M. El haig, MD
  phone: 01222155744
  phone ext: 002
  email: waelmohamed@medicine.zu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  citation: Demircan N, Soylu M, Yagmur M, Akkaya H, Ozcan AA, Varinli I. Pars plana vitrectomy in ocular injury with intraocular foreign body. J Trauma. 2005 Nov;59(5):1216-8. doi: 10.1097/01.ta.0000196438.48182.ff.
  PMID: 16385302
  citation: Loporchio D, Mukkamala L, Gorukanti K, Zarbin M, Langer P, Bhagat N. Intraocular foreign bodies: A review. Surv Ophthalmol. 2016 Sep-Oct;61(5):582-96. doi: 10.1016/j.survophthal.2016.03.005. Epub 2016 Mar 17.
  PMID: 26994871
  citation: Wani VB, Al-Ajmi M, Thalib L, Azad RV, Abul M, Al-Ghanim M, Sabti K. Vitrectomy for posterior segment intraocular foreign bodies: visual results and prognostic factors. Retina. 2003 Oct;23(5):654-60. doi: 10.1097/00006982-200310000-00008.
  PMID: 14574250
  citation: Wickham L, Xing W, Bunce C, Sullivan P. Outcomes of surgery for posterior segment intraocular foreign bodies--a retrospective review of 17 years of clinical experience. Graefes Arch Clin Exp Ophthalmol. 2006 Dec;244(12):1620-6. doi: 10.1007/s00417-006-0359-6.
  PMID: 16788826
  responsible party type: Principal Investigator
  investigator affiliation: Zagazig University
  investigator full name: Abbas Abomesslam Ali Hashem
  investigator title: assistant lecturer
  mesh term: Eye Foreign Bodies
  mesh term: Foreign Bodies