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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00697528
First received: June 11, 2008
Last updated: December 18, 2013
Last verified: June 2008

June 11, 2008
December 18, 2013
January 2007
December 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00697528 on ClinicalTrials.gov Archive Site
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Not Provided
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Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy
Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

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

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
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with Grave's disease within the orbital service of HCFMUSP at the Ophthalmology Department

  • Graves' Disease
  • Graves' Ophthalmopathy
Not Provided
  • 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.
Monteiro ML, Moritz RB, Angotti Neto H, Benabou JE. Color Doppler imaging of the superior ophthalmic vein in patients with Graves' orbitopathy before and after treatment of congestive disease. Clinics (Sao Paulo). 2011;66(8):1329-34.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncertain cases, with an undefined status of Grave's Ophthalmopathy.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00697528
352/06
Yes
Hélio Angotti Neto, HCFMUSP - University of São Paulo
University of Sao Paulo
Not Provided
Study Director: Mário LR Monteiro, Professor Instituto do Coracao
Study Chair: Joseph E Benabou Instituto do Coracao
University of Sao Paulo
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP