<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/NCT04464109</url>
  </required_header>
  <id_info>
    <org_study_id>R116/2020</org_study_id>
    <nct_id>NCT04464109</nct_id>
  </id_info>
  <brief_title>Comparative Motility of Alloplastic Orbital Implants</brief_title>
  <official_title>Comparative Motility of Retro-scleral and Intrascleral Orbital Implants After Evisceration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fayoum University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fayoum University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 will evaluate the effect of posterior placement of orbital implants on their&#xD;
      motility compared to intrascleral placement after evisceration .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evisceration allows removal of the intraocular contents while preserving the sclera and&#xD;
      normal extraocular muscle attachments. It is more advantageous than enucleation in patients&#xD;
      in whom intraocular tumor is rules out.&#xD;
&#xD;
      Maximizing orbital volume and restoration of movement are important aspects of a successful&#xD;
      surgical outcome.&#xD;
&#xD;
      Standard evisceration techniques do not allow placement of an implant larger than 13-16 mm&#xD;
      which don't adequately replace the volume leading to postevisceration socket syndrome.&#xD;
      Therefore, various techniques have been described to expand the scleral cavity and allow&#xD;
      placement of a large implant including anterior sclerotomies, posterior sclerotomies, and&#xD;
      disinsertion of optic nerve.&#xD;
&#xD;
      Implant exposure is a terrible complication of evisceration with reported rates as high as&#xD;
      67%. Exposure of the implant can lead to infection, which usually mandates removal of the&#xD;
      implant. Trying to minimize this risk, physicians intentionally place the implants posterior&#xD;
      to the normal position of the globe. Some authors described placement of the implant&#xD;
      posterior to posterior sclera which totally eliminated the risk of exposure.&#xD;
&#xD;
      However, this deep seating of the implant may have deleterious effects on its motility. It&#xD;
      can decrease implant-prosthesis interaction. In addition, retro-scleral placement of the&#xD;
      implant moves it posterior to the pulleys that serve as the functional origins of rectus&#xD;
      muscles. This relationship would be expected to alter the pulling directions of the rectus&#xD;
      muscles after evisceration hindering effective implant motility.&#xD;
&#xD;
      In this trial the investigators will try to study the effect of posterior placement of the&#xD;
      implants on its motility after evisceration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implant motility</measure>
    <time_frame>6 months</time_frame>
    <description>The conjunctiva is marked at the center point of the implant while the patient looking in primary gaze. The excursion of the mark will be measured will a standard millimeter ruler in extreme gaze positions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prosthesis motility</measure>
    <time_frame>6 months</time_frame>
    <description>It will be measured with the kestenbaum's limbus test. Photographs will be taken while patients wearing Kestenbaum spectacles in vertical and horizontal directions of gaze.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Volume augmentation</measure>
    <time_frame>6 months</time_frame>
    <description>Exophthalmometry will be performed for all patients after fitting a prosthesis. Enophthalmos is to be graded from 1 to 4 (grade 1 = no postoperative improvement; grade 2 = improvement &lt;2 mm but remained enophthalmos; grade 3 = improvement ≥2 mm but remained enophthalmos; and grade 4 = no enophthalmos) compared with unaffected side.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Anophthalmos; Acquired</condition>
  <condition>Evisceration; Traumatic, Eye</condition>
  <arm_group>
    <arm_group_label>Retro-scleral placement of the implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical steps;&#xD;
Two anterior scleral relaxing incisions&#xD;
A 360° scleral incision around the optic nerve to disinsert it&#xD;
Two posterior scleral relaxing incisions&#xD;
The implant is inserted posterior to posterior scleral edges&#xD;
The posterior sclera is closed then the anterior sclera is overlapped and closed.&#xD;
The implant is completely seated in the intraconal space</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrascleral placement of the implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Anterior and posterior sclerotomies with the implant partly in the scleral shell and partly in the intraconal space.&#xD;
Anterior relaxing sclerotomies not reaching the optic nerve&#xD;
A 360° scleral incision around the optic nerve.&#xD;
The anterior sclera flaps are overlapped and closed&#xD;
Part of the implant remains in the scleral shell, while the remaining part is sitting in the intraconal space.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Evisceration with orbital implantation</intervention_name>
    <description>Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.</description>
    <arm_group_label>Intrascleral placement of the implant</arm_group_label>
    <arm_group_label>Retro-scleral placement of the implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are candidates for evisceration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide independent, informed consent&#xD;
&#xD;
          -  Significant preoperative motility abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mostafa Mohammed M Diab, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fayoum University Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mostafa Mohammed M Diab, PhD</last_name>
    <phone>01016737314</phone>
    <email>mmd11@fayoum.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Richard C Allen, PhD</last_name>
    <email>Richardcutlerallen@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mostafa Mohammed Mohammed Diab</name>
      <address>
        <city>Fayoum</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mostafa Mohammed M Diab, PhD</last_name>
      <phone>01016737314</phone>
      <email>mmd11@fayoum.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Richard C Allen, PhD</last_name>
      <email>richardcutlerallen@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fayoum University Hospital</investigator_affiliation>
    <investigator_full_name>Mostafa Mohammed Mohammed Diab</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Evisceration</keyword>
  <keyword>Orbital implant</keyword>
  <keyword>Implant position</keyword>
  <keyword>Implant motility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anophthalmos</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data that support the findings of this study will be available upon reasonable request from the corresponding author, after deidentification. The data are not publicly available due to their containing information that could compromise the privacy of research participants. Study protocol will be also available. Data will be available for researchers who provide a methodologically sound proposal.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available beginning 6 months after starting the trial and ending 12 months following article publication</ipd_time_frame>
    <ipd_access_criteria>from corresponding author</ipd_access_criteria>
  </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/NCT04464109
org study id: R116/2020
nct id: NCT04464109
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effect of posterior placement of orbital implants on their
      motility compared to intrascleral placement after evisceration .
Evisceration allows removal of the intraocular contents while preserving the sclera and
      normal extraocular muscle attachments. It is more advantageous than enucleation in patients
      in whom intraocular tumor is rules out.

      Maximizing orbital volume and restoration of movement are important aspects of a successful
      surgical outcome.

      Standard evisceration techniques do not allow placement of an implant larger than 13-16 mm
      which don't adequately replace the volume leading to postevisceration socket syndrome.
      Therefore, various techniques have been described to expand the scleral cavity and allow
      placement of a large implant including anterior sclerotomies, posterior sclerotomies, and
      disinsertion of optic nerve.

      Implant exposure is a terrible complication of evisceration with reported rates as high as
      67%. Exposure of the implant can lead to infection, which usually mandates removal of the
      implant. Trying to minimize this risk, physicians intentionally place the implants posterior
      to the normal position of the globe. Some authors described placement of the implant
      posterior to posterior sclera which totally eliminated the risk of exposure.

      However, this deep seating of the implant may have deleterious effects on its motility. It
      can decrease implant-prosthesis interaction. In addition, retro-scleral placement of the
      implant moves it posterior to the pulleys that serve as the functional origins of rectus
      muscles. This relationship would be expected to alter the pulling directions of the rectus
      muscles after evisceration hindering effective implant motility.

      In this trial the investigators will try to study the effect of posterior placement of the
      implants on its motility after evisceration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Implant motility
time frame: 6 months
description: The conjunctiva is marked at the center point of the implant while the patient looking in primary gaze. The excursion of the mark will be measured will a standard millimeter ruler in extreme gaze positions
measure: Prosthesis motility
time frame: 6 months
description: It will be measured with the kestenbaum's limbus test. Photographs will be taken while patients wearing Kestenbaum spectacles in vertical and horizontal directions of gaze.
measure: Volume augmentation
time frame: 6 months
description: Exophthalmometry will be performed for all patients after fitting a prosthesis. Enophthalmos is to be graded from 1 to 4 (grade 1 = no postoperative improvement; grade 2 = improvement <2 mm but remained enophthalmos; grade 3 = improvement ≥2 mm but remained enophthalmos; and grade 4 = no enophthalmos) compared with unaffected side.
arm group label: Retro-scleral placement of the implant
arm group type: Active Comparator
description: Surgical steps;
Two anterior scleral relaxing incisions
A 360° scleral incision around the optic nerve to disinsert it
Two posterior scleral relaxing incisions
The implant is inserted posterior to posterior scleral edges
The posterior sclera is closed then the anterior sclera is overlapped and closed.
The implant is completely seated in the intraconal space
arm group label: Intrascleral placement of the implant
arm group type: Active Comparator
description: Anterior and posterior sclerotomies with the implant partly in the scleral shell and partly in the intraconal space.
Anterior relaxing sclerotomies not reaching the optic nerve
A 360° scleral incision around the optic nerve.
The anterior sclera flaps are overlapped and closed
Part of the implant remains in the scleral shell, while the remaining part is sitting in the intraconal space.
intervention type: Procedure
intervention name: Evisceration with orbital implantation
description: Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.
arm group label: Intrascleral placement of the implant
arm group label: Retro-scleral placement of the implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mostafa Mohammed M Diab, PhD
role: Principal Investigator
affiliation: Fayoum University Hospitals
last name: Mostafa Mohammed M Diab, PhD
phone: 01016737314
email: mmd11@fayoum.edu.eg
last name: Richard C Allen, PhD
email: Richardcutlerallen@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Fayoum University Hospital
investigator full name: Mostafa Mohammed Mohammed Diab
investigator title: Principal investigator
mesh term: Anophthalmos
sharing ipd: Yes
ipd description: The data that support the findings of this study will be available upon reasonable request from the corresponding author, after deidentification. The data are not publicly available due to their containing information that could compromise the privacy of research participants. Study protocol will be also available. Data will be available for researchers who provide a methodologically sound proposal.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available beginning 6 months after starting the trial and ending 12 months following article publication
ipd access criteria: from corresponding author