<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/NCT03278964</url>
  </required_header>
  <id_info>
    <org_study_id>39748114.0.0000.0068</org_study_id>
    <nct_id>NCT03278964</nct_id>
  </id_info>
  <brief_title>Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy</brief_title>
  <official_title>Comparative Morphometric, Functional and Psychosocial Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General 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>
      Randomized prospective clinical trial, aiming to compare two techniques of orbital&#xD;
      decompression. Patients with Graves orbitopathy in the inactive phase for at least 6 months&#xD;
      will be divided in two groups; one group will be submitted to orbital decompression by&#xD;
      antro-ethmoidal technique; the other group will be submitted to orbital decompression by&#xD;
      lateral wall technique. Patients will be followed up for a period of 6 months after the&#xD;
      surgery, and will be evaluated about the effect of orbital decompression on ocular motility,&#xD;
      proptosis, ocular surface and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Graves' orbitopathy is the most relevant non-thyroid manifestation of Graves' disease. Its&#xD;
      clinical status varies from subclinical to severe deformities. Clinical features include&#xD;
      palpebral retraction, exophthalmos, restrictive strabismus, chemosis, ocular surface lesions&#xD;
      and optic neuropathy. There are two stages of the disease. There is an active phase in which&#xD;
      the inflammatory process is present and the orbital changes evolve. The inactive phase&#xD;
      comprises a stable clinical picture regarding the sequelae of the active phase. Orbital&#xD;
      decompression surgery is the main treatment procedure for this inactive phase for functional&#xD;
      and cosmetic rehabilitation purposes. In the last decades, great advances in the techniques&#xD;
      and indication of this surgery have been observed. However, a consensus about the ideal&#xD;
      technique does not yet exist. The most commonly used techniques are antro-ethmoidal&#xD;
      decompression and lateral wall decompression alone or associated with other walls. The&#xD;
      present study will be based on patients with Graves' orbitopathy diagnosis for at least 2&#xD;
      years and who are already in the inactive phase for at least 6 months. There are no&#xD;
      prospective studies comparing the 2 main orbital decompression techniques through a detailed&#xD;
      analysis of surgical outcomes from computed tomography images, digital photographic images&#xD;
      and ocular motility examination. These informations will be collected in the preoperative and&#xD;
      postoperative periods. The investigators will evaluate the decompressive potential of each&#xD;
      technique calculated by the tomographic images. Participants will be followed up for a period&#xD;
      of 6 months after the surgical procedure and the effect of decompression on ocular motility,&#xD;
      ocular bulb positioning, ocular surface, vertical palpebral fissure, and the patient's&#xD;
      quality of life will also be analyzed. The findings of this work will bring important&#xD;
      contribution to the improvement of this surgical procedure of great relevance in the&#xD;
      rehabilitation of patients with Graves' orbitopathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2015</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>
    <intervention_model_description>Patients with Graves orbitopathy will be randomly divided in two groups. One group will be submmited to orbital decompression by antro-ethmoidal technique. The other group will be treated by lateral wall technique.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants and investigators do not know which orbital decompression technique will be done until 6 months of postoperative period.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Ocular Motility status</measure>
    <time_frame>Before orbital decompression and 1, 3 and 6 months after surgery</time_frame>
    <description>Measure by prism and cover, to assess strabismus in the nine positions of gaze</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exophthalmos</measure>
    <time_frame>Before orbital decompression and 6 months after surgery</time_frame>
    <description>Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diplopia</measure>
    <time_frame>Before orbital decompression and 1, 3 and 6 months after surgery</time_frame>
    <description>Evaluation by Gorman's Diplopia Table</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digital photography evaluation</measure>
    <time_frame>Before orbital decompression and 6 months after surgery</time_frame>
    <description>Using digital photography, Photoshop and Image J, ductions and versions will be analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of the extraocular muscles</measure>
    <time_frame>Before orbital decompression and 6 months after surgery</time_frame>
    <description>Measure by orbital computerized tomography images</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular surface evaluation</measure>
    <time_frame>Before orbital decompression and 6 months after surgery</time_frame>
    <description>Assessed by Lysozyme Green, Break-up time, Schirmer I test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionary Quality of life questionary</measure>
    <time_frame>Before orbital decompression and 6 months after surgery</time_frame>
    <description>GO-QoL form</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Graves Ophthalmopathy</condition>
  <arm_group>
    <arm_group_label>Antro-ethmoidal technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lateral wall technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Orbital decompression</intervention_name>
    <arm_group_label>Antro-ethmoidal technique</arm_group_label>
    <arm_group_label>Lateral wall technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Graves orbitopathy for at least 2 years&#xD;
&#xD;
          -  Clinical Activity Score (CAS) &lt; 4 for at least 6 months&#xD;
&#xD;
          -  Agreement with the Informed Consent Form, which will be signed during the selection&#xD;
             visit&#xD;
&#xD;
          -  Ability to come to periodic evaluations for 6 months after the orbital decompression&#xD;
&#xD;
          -  Absence of ocular abnormalities such as degenerative myopia, microphthalmia or&#xD;
             anophthalmic cavity&#xD;
&#xD;
          -  Absence of orbital abnormalities such as previous fractures or congenital defects&#xD;
&#xD;
          -  Good collaboration for the exams&#xD;
&#xD;
          -  Euthyroidism&#xD;
&#xD;
          -  Exophthalmus ≥ 20 mm in Hertel's exophthalmometry&#xD;
&#xD;
          -  Preoperative clinical evaluation indicating absence of contraindications for a&#xD;
             surgical procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Myasthenia gravis&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous orbital, strabismus or eyelid surgery&#xD;
&#xD;
          -  Other abnormal eye conditions or symptoms that make it impossible to admit the patient&#xD;
             to the study, according to the clinical judgment of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARIO L RIBEIRO MONTEIRO, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sao Paulo General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Sao Paulo General Hospital</name>
      <address>
        <city>São Paulo</city>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>August 11, 2019</last_update_submitted>
  <last_update_submitted_qc>August 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Cristiane de Almeida Leite</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Graves Disease</keyword>
  <keyword>Orbital decompression</keyword>
  <keyword>Graves Orbitopathy</keyword>
  <keyword>Exophthalmos</keyword>
  <keyword>Diplopia</keyword>
  <keyword>Restrictive Strabismus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Graves Ophthalmopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03278964
org study id: 39748114.0.0000.0068
nct id: NCT03278964
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Randomized prospective clinical trial, aiming to compare two techniques of orbital
      decompression. Patients with Graves orbitopathy in the inactive phase for at least 6 months
      will be divided in two groups; one group will be submitted to orbital decompression by
      antro-ethmoidal technique; the other group will be submitted to orbital decompression by
      lateral wall technique. Patients will be followed up for a period of 6 months after the
      surgery, and will be evaluated about the effect of orbital decompression on ocular motility,
      proptosis, ocular surface and quality of life.
Graves' orbitopathy is the most relevant non-thyroid manifestation of Graves' disease. Its
      clinical status varies from subclinical to severe deformities. Clinical features include
      palpebral retraction, exophthalmos, restrictive strabismus, chemosis, ocular surface lesions
      and optic neuropathy. There are two stages of the disease. There is an active phase in which
      the inflammatory process is present and the orbital changes evolve. The inactive phase
      comprises a stable clinical picture regarding the sequelae of the active phase. Orbital
      decompression surgery is the main treatment procedure for this inactive phase for functional
      and cosmetic rehabilitation purposes. In the last decades, great advances in the techniques
      and indication of this surgery have been observed. However, a consensus about the ideal
      technique does not yet exist. The most commonly used techniques are antro-ethmoidal
      decompression and lateral wall decompression alone or associated with other walls. The
      present study will be based on patients with Graves' orbitopathy diagnosis for at least 2
      years and who are already in the inactive phase for at least 6 months. There are no
      prospective studies comparing the 2 main orbital decompression techniques through a detailed
      analysis of surgical outcomes from computed tomography images, digital photographic images
      and ocular motility examination. These informations will be collected in the preoperative and
      postoperative periods. The investigators will evaluate the decompressive potential of each
      technique calculated by the tomographic images. Participants will be followed up for a period
      of 6 months after the surgical procedure and the effect of decompression on ocular motility,
      ocular bulb positioning, ocular surface, vertical palpebral fissure, and the patient's
      quality of life will also be analyzed. The findings of this work will bring important
      contribution to the improvement of this surgical procedure of great relevance in the
      rehabilitation of patients with Graves' orbitopathy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients with Graves orbitopathy will be randomly divided in two groups. One group will be submmited to orbital decompression by antro-ethmoidal technique. The other group will be treated by lateral wall technique.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Participants and investigators do not know which orbital decompression technique will be done until 6 months of postoperative period.
measure: Change in Ocular Motility status
time frame: Before orbital decompression and 1, 3 and 6 months after surgery
description: Measure by prism and cover, to assess strabismus in the nine positions of gaze
measure: Exophthalmos
time frame: Before orbital decompression and 6 months after surgery
description: Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography
measure: Diplopia
time frame: Before orbital decompression and 1, 3 and 6 months after surgery
description: Evaluation by Gorman's Diplopia Table
measure: Digital photography evaluation
time frame: Before orbital decompression and 6 months after surgery
description: Using digital photography, Photoshop and Image J, ductions and versions will be analyzed
measure: Volume of the extraocular muscles
time frame: Before orbital decompression and 6 months after surgery
description: Measure by orbital computerized tomography images
measure: Ocular surface evaluation
time frame: Before orbital decompression and 6 months after surgery
description: Assessed by Lysozyme Green, Break-up time, Schirmer I test
measure: Quality of life questionary Quality of life questionary
time frame: Before orbital decompression and 6 months after surgery
description: GO-QoL form
arm group label: Antro-ethmoidal technique
arm group type: Active Comparator
description: Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique.
arm group label: Lateral wall technique
arm group type: Experimental
description: Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique.
intervention type: Procedure
intervention name: Orbital decompression
arm group label: Antro-ethmoidal technique
arm group label: Lateral wall technique
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: MARIO L RIBEIRO MONTEIRO, PHD
role: Study Chair
affiliation: University of Sao Paulo General Hospital
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Cristiane de Almeida Leite
investigator title: Medical Doctor
mesh term: Eye Diseases
mesh term: Graves Ophthalmopathy
sharing ipd: Undecided