Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy - Full Text View

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00697528

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

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

U.S. FDA Resources

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

Further study details as provided by University of Sao Paulo:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Control with healthy subjects
2 Grave's Disease patients in the fibrotic phase
3 Grave's Disease patients in the active 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

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

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

Contacts

Contact: Hélio Angotti-Neto, PostGraduate	34-3314-0999	helioangotti@ig.com.br
Contact: Hélio Angotti-Neto, PostGraduate	34-8848-6100	helioangotti@gmail.com

Locations

Brazil
Hospital das Clínicas da Universidade São Paulo	Recruiting
São Paulo, Brazil, 05403-000
Principal Investigator: Hélio Angotti-Neto

Sponsors and Collaborators

University of Sao Paulo

Investigators

Study Director:	Mário LR Monteiro, Professor	HCFMUSP
Study Chair:	Joseph E Benabou	HCFMUSP

More Information

Responsible Party:	HCFMUSP - University of São Paulo ( Hélio Angotti Neto )
Study ID Numbers:	352/06
Study First Received:	June 11, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00697528
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:

Graves
Color Doppler Imaging
Graves' Ophthalmopathy
Orbital Venous Flow

Study placed in the following topic categories:

Goiter
Autoimmune Diseases
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Eye Diseases, Hereditary

Endocrine System Diseases
Endocrinopathy
Orbital Diseases
Graves' disease
Hyperthyroidism
Thyroid Diseases

Additional relevant MeSH terms:

Immune System Diseases
Exophthalmos

ClinicalTrials.gov processed this record on January 15, 2009