NCT00697528

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 19, 2013

Status Verified

June 1, 2008

Enrollment Period

1.9 years

First QC Date

June 11, 2008

Last Update Submit

December 18, 2013

Conditions

Graves' DiseaseGraves' Ophthalmopathy

Keywords

GravesColor Doppler ImagingGraves' OphthalmopathyOrbital Venous Flow

Study Arms (3)

Group control with healthy subjects

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

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.

Graves' Ophthalmopathy - active phase

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Grave's disease within the orbital service of HCFMUSP at the Ophthalmology Department

You may qualify if:

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

You may not qualify if:

  • Uncertain cases, with an undefined status of Grave's Ophthalmopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Universidade São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 21915479DERIVED

MeSH Terms

Conditions

Graves DiseaseGraves Ophthalmopathy

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mário LR Monteiro, Professor

    Instituto do Coracao

    STUDY DIRECTOR

  • Joseph E Benabou

    Instituto do Coracao

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 16, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 19, 2013

Record last verified: 2008-06

Locations

BR(1)