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Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy

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ClinicalTrials.gov Identifier: NCT00665795
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Dysthyroid Orbitopathy

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).

Study Design

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy Using Multidetector Computed Tomography Scan and Color Doppler Imaging.
Study Start Date : July 2005
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

1Patients with Graves´orbitophathy.
Patients with Graves´orbitophathy.
2 Patients with detected DON
Patients with Graves´orbitophaty and detected dysthyroid optic neuropathy (DON)

Outcome Measures

Primary Outcome Measures :
  1. screening indexes for dysthyroid optic neuropathy [ Time Frame: indexes above 60% of orbital apex crowding were high suspected for DON ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Graves´ orbitopathy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665795

General Hospital - University of Sao Paulo - School of Medicine
São Paulo, Brazil, 05409 000
Sponsors and Collaborators
University of Sao Paulo
Study Chair: Mario L Monteiro, MD, PhD University of Sao Paulo - School of Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allan Christian Pieroni Goncalves, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00665795     History of Changes
Other Study ID Numbers: 1152/05
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Allan Christian Pieroni Goncalves, University of Sao Paulo:
Dysthyroid Optic Neuropathy
multidetector computed tomography
color doppler
Grave´s Orbitopathy
Grave´s Disease
morphometric analysis

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