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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697528
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : December 19, 2013
Information provided by:
University of Sao Paulo

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
Graves' Disease Graves' Ophthalmopathy

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 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 : January 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Grave's disease within the orbital service of HCFMUSP at the Ophthalmology Department

Inclusion Criteria:

  • Clinical diagnosis of Grave's Orbitopathy with well defined disease.

Exclusion Criteria:

  • Uncertain cases, with an undefined status of Grave's Ophthalmopathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697528

Hospital das Clínicas da Universidade São Paulo
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Study Director: Mário LR Monteiro, Professor Instituto do Coracao
Study Chair: Joseph E Benabou Instituto do Coracao

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hélio Angotti Neto, HCFMUSP - University of São Paulo Identifier: NCT00697528     History of Changes
Other Study ID Numbers: 352/06
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: June 2008

Keywords provided by University of Sao Paulo:
Color Doppler Imaging
Graves' Ophthalmopathy
Orbital Venous Flow

Additional relevant MeSH terms:
Graves Disease
Eye Diseases
Graves Ophthalmopathy
Orbital Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases, Hereditary