NCT00665795

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 for all trials

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

July 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

8.3 years

First QC Date

April 22, 2008

Last Update Submit

November 17, 2013

Conditions

Dysthyroid Orbitopathy

Keywords

Dysthyroid Optic Neuropathymultidetector computed tomographycolor dopplerGrave´s OrbitopathyGrave´s Diseasemorphometric analysis

Outcome Measures

Primary Outcomes (1)

  • screening indexes for dysthyroid optic neuropathy

    indexes above 60% of orbital apex crowding were high suspected for DON

Study Arms (2)

1Patients with Graves´orbitophathy.

Patients with Graves´orbitophathy.

2 Patients with detected DON

Patients with Graves´orbitophaty and detected dysthyroid optic neuropathy (DON)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Graves´ orbitopathy

You may qualify if:

  • 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

You may not qualify if:

  • Graves´Orbitopathy not diagnosed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital - University of Sao Paulo - School of Medicine

São Paulo, São Paulo, 05409 000, Brazil

Location

Related Publications (1)

  • Goncalves AC, Silva LN, Gebrim EM, Monteiro ML. Quantification of orbital apex crowding for screening of dysthyroid optic neuropathy using multidetector CT. AJNR Am J Neuroradiol. 2012 Sep;33(8):1602-7. doi: 10.3174/ajnr.A3029. Epub 2012 Mar 22.

    PMID: 22442048DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mario L Monteiro, MD, PhD

    University of Sao Paulo - School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

July 1, 2005

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

BR(1)