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Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

NCT ID: NCT00697528

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-12-31

Brief Summary

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Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging

Detailed Description

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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

Conditions

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Graves' Disease Graves' Ophthalmopathy

Keywords

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Graves Color Doppler Imaging Graves' Ophthalmopathy Orbital Venous Flow

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group control with healthy subjects

Healthy subjects without thyroid disease, ocular disease and previous surgery in the orbit or eye used in the study.

No interventions assigned to this group

Graves' Ophthalmopathy - fibrotic phase

Patients that are clinically inactive (CAS equal or lower than 2). This group will be subdivided in the miogenic and lipogenic groups.

No interventions assigned to this group

Graves' Ophthalmopathy - active phase

Patients that are clinically active, presenting a CAS of 4 or more points, with or without disthyroid optic neuropathy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Grave's Orbitopathy with well defined disease.

Exclusion Criteria

* Uncertain cases, with an undefined status of Grave's Ophthalmopathy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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HCFMUSP - University of São Paulo

Principal Investigators

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Mário LR Monteiro, Professor

Role: STUDY_DIRECTOR

Instituto do Coracao

Joseph E Benabou

Role: STUDY_CHAIR

Instituto do Coracao

Locations

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Hospital das Clínicas da Universidade São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Monteiro ML, Moritz RB, Angotti Neto H, Benabou JE. Color Doppler imaging of the superior ophthalmic vein in patients with Graves' orbitopathy before and after treatment of congestive disease. Clinics (Sao Paulo). 2011;66(8):1329-34. doi: 10.1590/s1807-59322011000800004.

Reference Type DERIVED
PMID: 21915479 (View on PubMed)

Other Identifiers

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352/06

Identifier Type: -

Identifier Source: org_study_id