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Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy
This study is currently recruiting participants.
Verified by University of Sao Paulo, June 2008
First Received: April 22, 2008   Last Updated: June 5, 2008   History of Changes
Sponsored by: University of Sao Paulo
Information provided by: University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00665795
  Purpose

The purpose of this protocol is to study orbital structures in Graves´ Disease using multidetector computed tomography and color doppler imaging.

Some changes in orbital structures detected by imaging exams could predict severity of the ocular Graves´disease. Thus the study could be useful in improve medical management of patients with Graves´ Disease.


Condition
Dysthyroid Orbitopathy

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome
MedlinePlus related topics: CT Scans
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy Using Multidetector Computed Tomography Scan and Color Doppler Imaging.

Further study details as provided by University of Sao Paulo:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 80
Study Start Date: July 2005
Estimated Study Completion Date: December 2008
Groups/Cohorts
1
Patients with Graves´orbitophathy.
2
Patients with Graves´orbitophaty and detected dysthyroid optic neuropathy (DON)

Detailed Description:

Morphometric analysis of orbital structures in Graves´ Orbitopathy using multidetector computed tomography scan and color doppler imaging:

Patients with Graves´ orbitopathy are evaluated by a complete ophthalmic examination.A prospective study with Multidetector CT scan and Color Doppler of these patients are made to develop parameters capable to predict Dysthyroid Optic Neuropathy (DON).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Graves´ orbitopathy

Criteria

Inclusion Criteria:

  • Graves´Orbitopathy diagnosed based on previously reported criteria;
  • age above 20 years;
  • good cooperation for performing Visual Field test;
  • spherical refraction within ± 5 D and cylinder correction within ± 3 D

Exclusion Criteria:

  • Graves´Orbitopathy not diagnosed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665795

Contacts
Contact: Allan C Goncalves, MD 55-11-9656-4492 ext - allanpieroni@uol.com.br
Contact: Mario L Monteiro, MD, PhD 55-11-3069-7871 mlrmonteiro@terra.com.br

Locations
Brazil
General Hospital - University of Sao Paulo - School of Medicine Recruiting
São Paulo, Brazil, 05409 000
Principal Investigator: Allan C Goncalves, MD            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Mario L Monteiro, MD, PhD University of Sao Paulo - School of Medicine
  More Information

No publications provided

Responsible Party: University of Sao Paulo - School of Medicine ( Allan Christian Pieroni Goncalves )
Study ID Numbers: 1152/05
Study First Received: April 22, 2008
Last Updated: June 5, 2008
ClinicalTrials.gov Identifier: NCT00665795     History of Changes
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Dysthyroid Optic Neuropathy;
multidetector computed tomography;
color doppler
Grave´s Orbitopathy;
Grave´s Disease
morphometric analysis

Study placed in the following topic categories:
Goiter
Autoimmune Diseases
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Endocrine System Diseases
Optic Nerve Disorder
Graves' Disease
Eye Diseases, Hereditary
Optic Nerve Diseases
Endocrinopathy
Orbital Diseases
Thyroid Diseases
Hyperthyroidism

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

ClinicalTrials.gov processed this record on May 07, 2009