<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/NCT03748732</url>
  </required_header>
  <id_info>
    <org_study_id>RaficHaririUHAMM</org_study_id>
    <nct_id>NCT03748732</nct_id>
  </id_info>
  <brief_title>Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes</brief_title>
  <official_title>Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rafic Hariri University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rafic Hariri 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>
      Purpose: To describe an extensive scleral excision technique to treat or prevent uveal&#xD;
      effusion in nanophthalmic eyes.&#xD;
&#xD;
      Design: Prospective interventional case series.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
        -  Setting: Institutional.&#xD;
&#xD;
        -  Patient Population: Consecutive patients with nanophthalmos were operated on by one&#xD;
           surgeon.&#xD;
&#xD;
        -  Intervention Procedure: A single, 90% thickness scleral window extending from&#xD;
           immediately behind the extraocular muscle insertions to the vortex veins was performed&#xD;
           for 3 and 1/4 quadrants as a circumferential strip.&#xD;
&#xD;
        -  Main Outcome Measure: Resolution or prevention of uveal effusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical Technique All surgeries were performed under general anesthesia by one surgeon&#xD;
      (AMM). Because the majority of the patients were young with narrow palpebral fissures and&#xD;
      very deep set globes in small orbits, special surgical techniques were required. Lateral&#xD;
      canthotomy was performed on all patients except for the first. Limbal 360o conjunctival&#xD;
      peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0&#xD;
      silk suture. Scleral dissection was performed from immediately behind to the muscle&#xD;
      insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼&#xD;
      quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior&#xD;
      oblique muscle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>surgery</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>resolution of uveal effusion</measure>
    <time_frame>1 month</time_frame>
    <description>disappearence of uveal effusion by OCT</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Nanophthalmos</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sclerectomy</intervention_name>
    <description>scleral flap</description>
    <other_name>maximal scleral excision</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: nanophthalmos -&#xD;
&#xD;
        Exclusion Criteria: None&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmad Mansour, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Rafic Hariri University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rafic Hariri University Hospital</name>
      <address>
        <city>Beirut</city>
        <state>South Beirut</state>
        <zip>1136044</zip>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <results_reference>
    <citation>Carricondo PC, Andrade T, Prasov L, Ayres BM, Moroi SE. Nanophthalmos: A Review of the Clinical Spectrum and Genetics. J Ophthalmol. 2018 May 9;2018:2735465. doi: 10.1155/2018/2735465. eCollection 2018.</citation>
    <PMID>29862063</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 18, 2018</last_update_submitted>
  <last_update_submitted_qc>November 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rafic Hariri University Hospital</investigator_affiliation>
    <investigator_full_name>Ahmad Mansour, MD, Clinical Professor, AUB</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>uveal effusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Microphthalmos</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>if part of collaboration, we will share the data</ipd_description>
  </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/NCT03748732
org study id: RaficHaririUHAMM
nct id: NCT03748732
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose: To describe an extensive scleral excision technique to treat or prevent uveal
      effusion in nanophthalmic eyes.

      Design: Prospective interventional case series.

      Methods:

        -  Setting: Institutional.

        -  Patient Population: Consecutive patients with nanophthalmos were operated on by one
           surgeon.

        -  Intervention Procedure: A single, 90% thickness scleral window extending from
           immediately behind the extraocular muscle insertions to the vortex veins was performed
           for 3 and 1/4 quadrants as a circumferential strip.

        -  Main Outcome Measure: Resolution or prevention of uveal effusion.
Surgical Technique All surgeries were performed under general anesthesia by one surgeon
      (AMM). Because the majority of the patients were young with narrow palpebral fissures and
      very deep set globes in small orbits, special surgical techniques were required. Lateral
      canthotomy was performed on all patients except for the first. Limbal 360o conjunctival
      peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0
      silk suture. Scleral dissection was performed from immediately behind to the muscle
      insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼
      quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior
      oblique muscle.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: surgery
primary purpose: Treatment
masking: None (Open Label)
measure: resolution of uveal effusion
time frame: 1 month
description: disappearence of uveal effusion by OCT
intervention type: Procedure
intervention name: sclerectomy
description: scleral flap
other name: maximal scleral excision
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ahmad Mansour, MD
role: Study Chair
affiliation: Rafic Hariri University Hospital
facility: 
country: Lebanon
citation: Carricondo PC, Andrade T, Prasov L, Ayres BM, Moroi SE. Nanophthalmos: A Review of the Clinical Spectrum and Genetics. J Ophthalmol. 2018 May 9;2018:2735465. doi: 10.1155/2018/2735465. eCollection 2018.
PMID: 29862063
responsible party type: Principal Investigator
investigator affiliation: Rafic Hariri University Hospital
investigator full name: Ahmad Mansour, MD, Clinical Professor, AUB
investigator title: Professor
mesh term: Microphthalmos
sharing ipd: Undecided
ipd description: if part of collaboration, we will share the data