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

Study Overview

• Status: Completed
• Conditions: Graves' Ophthalmopathy; Graves' Disease

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
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital das Clínicas da Universidade São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Director: Mário LR Monteiro, Professor, Instituto do Coracao; Study Chair: Joseph E Benabou, Instituto do Coracao

Publications and helpful links

General Publications

• 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. doi: 10.1590/s1807-59322011000800004.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (Estimate): June 16, 2008

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Graves' Ophthalmopathy; Graves; Color Doppler Imaging; Orbital Venous Flow
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Thyroid Diseases; Eye Diseases, Hereditary; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy; Graves Disease
• Other Study ID Numbers: 352/06