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Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT00697528
Collaborator
(none)
66
Enrollment
1
Location
23
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective study with Grave's patients in active and fibrotic disease, myogenic and lipogenic forms, with muscle restriction and without muscle restriction and with or without optic compressive neuropathy. Blood flow was studied with Color Doppler Imaging (CDI) in the following orbital vessels:

    • Superior Ophthalmic Vein (main target of the study protocol)

    • Retinal Central Vein

    • Retinal Central Artery

    • Ophthalmic Artery

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    66 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy
    Study Start Date :
    Jan 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2008
    Actual Study Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    Group control with healthy subjects

    Healthy subjects without thyroid disease, ocular disease and previous surgery in the orbit or eye used in the study.
    Graves' Ophthalmopathy - fibrotic phase

    Patients that are clinically inactive (CAS equal or lower than 2). This group will be subdivided in the miogenic and lipogenic groups.
    Graves' Ophthalmopathy - active phase

    Patients that are clinically active, presenting a CAS of 4 or more points, with or without disthyroid optic neuropathy.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Clinical diagnosis of Grave's Orbitopathy with well defined disease.
      Exclusion Criteria:
      • Uncertain cases, with an undefined status of Grave's Ophthalmopathy.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hospital das Clínicas da Universidade São Paulo São Paulo Brazil 05403-000

      Sponsors and Collaborators

      • University of Sao Paulo

      Investigators

      • Study Director: Mário LR Monteiro, Professor, Instituto do Coracao
      • Study Chair: Joseph E Benabou, Instituto do Coracao

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00697528
      Other Study ID Numbers:
      • 352/06
      First Posted:
      Jun 16, 2008
      Last Update Posted:
      Dec 19, 2013
      Last Verified:
      Jun 1, 2008
      Keywords provided by , ,
      Graves
      Color Doppler Imaging
      Graves' Ophthalmopathy
      Orbital Venous Flow
      Additional relevant MeSH terms:
      Graves Disease
      Eye Diseases
      Graves Ophthalmopathy

      Study Results

      No Results Posted as of Dec 19, 2013