Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allan Christian Pieroni Goncalves, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00665795
First received: April 22, 2008
Last updated: November 17, 2013
Last verified: November 2013
  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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • screening indexes for dysthyroid optic neuropathy [ Time Frame: indexes above 60% of orbital apex crowding were high suspected for DON ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2005
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1Patients with Graves´orbitophathy.
Patients with Graves´orbitophathy.
2 Patients with detected DON
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00665795

Locations
Brazil
General Hospital - University of Sao Paulo - School of Medicine
São Paulo, Brazil, 05409 000
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 by University of Sao Paulo

Additional 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
Study First Received: April 22, 2008
Last Updated: November 17, 2013
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

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

ClinicalTrials.gov processed this record on October 23, 2014