Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy

Dysthyroid Orbitopathy Clinical Trial

Official title:

Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy Using Multidetector Computed Tomography Scan and Color Doppler Imaging.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665795
• Other study ID #: 1152/05
• Status: Completed
• Phase: N/A
• First received: April 22, 2008
• Last updated: November 17, 2013
• Start date: July 2005
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dysthyroid Orbitopathy
• Graves Ophthalmopathy

Locations

Country	Name	City	State
Brazil	General Hospital - University of Sao Paulo - School of Medicine	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	screening indexes for dysthyroid optic neuropathy		indexes above 60% of orbital apex crowding were high suspected for DON	No