Dysthyroid OrbitopathyNCT00665795
Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy
An observational study of Dysthyroid Orbitopathy, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dysthyroid Orbitopathy
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2005to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Graves´ orbitopathy
Who may be able to join
- 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
Who cannot join
- Graves´Orbitopathy not diagnosed
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital - University of Sao Paulo - School of Medicine
São Paulo, São Paulo, 05409 000
About this study
Official title: Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy Using Multidetector Computed Tomography Scan and Color Doppler Imaging.
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.
Read the 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).
- Conditions
- Dysthyroid Orbitopathy
- Keywords
- Dysthyroid Optic Neuropathy, multidetector computed tomography, color doppler, Grave´s Orbitopathy, Grave´s Disease, morphometric analysis
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1Patients with Graves´orbitophathy. | Patients with Graves´orbitophathy. | |
| 2 Patients with detected DON | Patients with Graves´orbitophaty and detected dysthyroid optic neuropathy (DON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening indexes for dysthyroid optic neuropathy
Measured: indexes above 60% of orbital apex crowding were high suspected for DON
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJul 2005
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysthyroid OrbitopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan Christian Pieroni Goncalves, University of Sao Paulo
- Investigators
- Mario L Monteiro, MD, PhD, Study chair, University of Sao Paulo - School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665795
- Sponsor's protocol ID
- 1152/05
- Status last verified
- Nov 2013
- First submitted
- 22 Apr 2008
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22442048
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy Using Multidetector Computed Tomography Scan and Color Doppler Imaging.
- ClinicalTrials.gov ID
- NCT00665795
- Acronym / sponsor ID
- 1152/05
- Conditions
- Dysthyroid Orbitopathy
- Keywords
- Dysthyroid Optic Neuropathy, multidetector computed tomography, color doppler, Grave´s Orbitopathy, Grave´s Disease, morphometric analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1Patients with Graves´orbitophathy. | – | –Patients with Graves´orbitophathy. |
| 2 Patients with detected DON | – | –Patients with Graves´orbitophaty and detected dysthyroid optic neuropathy (DON) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Graves´ orbitopathy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Graves´Orbitopathy not diagnosed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
screening indexes for dysthyroid optic neuropathy
Time frame: indexes above 60% of orbital apex crowding were high suspected for DON
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Derived from this study: PubMed 22442048Goncalves 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario L Monteiro, MD, PhD study chair
University of Sao Paulo - School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysthyroid Orbitopathy, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
screening indexes for dysthyroid optic neuropathy (time frame: indexes above 60% of orbital apex crowding were high suspected for DON). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00665795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013; AzTrials last refreshed its copy on 26 Oct 2026.