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
  Purpose

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


Condition
Graves' Disease
Graves' Ophthalmopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Enrollment: 66
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697528

Locations
Brazil
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
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hélio Angotti Neto, HCFMUSP - University of São Paulo
ClinicalTrials.gov Identifier: NCT00697528     History of Changes
Other Study ID Numbers: 352/06
Study First Received: June 11, 2008
Last Updated: December 18, 2013
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 25, 2014