Orbital Ischemic SyndromeSIOINCT01443000
Survey of Patients With Idiopathic Orbital Inflammation Syndrome
An observational study of Orbital Ischemic Syndrome and Orbital Pseudotumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Ischemic Syndrome, Orbital Pseudotumor
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2012to 3 Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed for IOIS
Who may be able to join
- Patients with biopsy proven IOIS or presumed IOIS
- Patients with chronic IOS
- Patient with inaugural IOIS or being treated for IOIS
Who cannot join
- Patients who do not fulfill the inclusion criteria
- Patients with systemic disease-associated IOIS
- Incomplete follow-up of patients treated for IOIS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey of Patients With Idiopathic Orbital Inflammation Syndrome (IOIS): Clinical, Morphological and Pathological Features and Treatment Outcomes
The purpose of this study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome.
Read the detailed description
Idiopathic orbital inflammatory syndrome (IOIS) is a heterogeneous group of disorders characterised by orbital inflammation without any identifiable local or systemic causes. It is a rare clinical entity and a diagnosis of exclusion. Lymphomas, thyroid eye diseases or systemic diseases can have similar presentation and so, a histopathological diagnosis is considered important. IOIS is a difficult condition to treat. Compilation of reported small series of patients with IOIS suggested that they require multiple systemic immunosuppressant drugs and radiotherapy. Recently, a large monocentric study including patients with biopsy proven IOIS showed that up to 40% of them can relapse. Their clinical and pathological features did not correlate with treatments outcomes. The investigators decide therefore to conduct a multicentric retro/ prospective study to determine clinical features, histopathology and treatment outcomes of French patients with IOIS.
- Conditions
- Orbital Ischemic Syndrome, Orbital Pseudotumor
- Keywords
- Observational study, IOIS, Orbital Pseudotumor, Outcome, Treatment
- Medical subject headings
- Orbital Pseudotumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of remission, relapse or resistance among patients with IOIS during the 24 month follow-up
Remission: absence of steroids, their withdrawal or their pursuit at a dose ≤ 10 mg/d in the absence of immunosuppressor treatment.
Relapse: re initiation of steroids, or their ascension in patients for whom they have been reduced to less than 20 mg/d.
Resistance: inability to reduce steroids at an effective dose ≤ 20 mg/d.
Measured: The remission, relapse, or the resistance at inclusion (for those previously diagnosed as IOIS), and at 6, 12, 18 and 24 months
Secondary outcomes (6)
Histopathological classification of IOIS patients
-Histopathological forms of the IOIS patients at diagnosis, according to the classification described by Mombaerts, namely: classical orbital pseudotumor, sclerosing orbital pseudotumor, granulomatous orbital pseudotumor and vasculitic pseudotumor.
Measured: at diagnostic
Ophthalmologic features (laterality, pain, visual acuity, eye movement and eyelid)
The clinical manifestations of systemic diseases mentioned below, will be evaluated in case of relapse or resistance: Grave's disease or auto immune thyroiditis, sarcoidosis, Wegener's granulomatosis, polyarteritis nodosa, Churg- Strauss syndrome, systemic lupus erythematosus and Gougerot-Sjögren syndrome.
Measured: at diagnosis and in case of remission, or relapse, or resistance
MRI features (muscle enlargement, irregular borders, extension to the orbital fat, enhancement around globe) of patients with IOIS
the lesional topography and the T1/T2 weighted sequences will be studied
Measured: at diagnosis and in case of remission, or relapse, or resistance.
Immunologic features of IOIS patients
the IgG4 level and ANA in sera will be assessed
Measured: at inclusion
Cumulated dose of prednisone
Measured: at remission, or relapse, or resistance
Incidence of orbital lymphomas
Measured: at 6, 12, 18, 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study start3 Mar 2012
- Primary completion3 Jun 2017
- Study completion3 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital Ischemic SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Sébastien ABAD, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443000
- Sponsor's protocol ID
- NI08014
- Other IDs
- 2010-A00512-37
- Acronym
- SIOI
- Status last verified
- Nov 2021
- First submitted
- 15 Jun 2011
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Patients With Idiopathic Orbital Inflammation Syndrome (IOIS): Clinical, Morphological and Pathological Features and Treatment Outcomes
- ClinicalTrials.gov ID
- NCT01443000
- Acronym / sponsor ID
- SIOI / NI08014
- Conditions
- Orbital Ischemic Syndrome, Orbital Pseudotumor
- Keywords
- Observational study, IOIS, Orbital Pseudotumor, Outcome, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 3 Mar 2012 (actual)
- Primary completion
- 3 Jun 2017 (actual)
- Study completion
- 3 Jun 2017 (actual)
- First posted
- 29 Sep 2011 (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 study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome.
Detailed description
Idiopathic orbital inflammatory syndrome (IOIS) is a heterogeneous group of disorders characterised by orbital inflammation without any identifiable local or systemic causes. It is a rare clinical entity and a diagnosis of exclusion. Lymphomas, thyroid eye diseases or systemic diseases can have similar presentation and so, a histopathological diagnosis is considered important. IOIS is a difficult condition to treat. Compilation of reported small series of patients with IOIS suggested that they require multiple systemic immunosuppressant drugs and radiotherapy. Recently, a large monocentric study including patients with biopsy proven IOIS showed that up to 40% of them can relapse. Their clinical and pathological features did not correlate with treatments outcomes. The investigators decide therefore to conduct a multicentric retro/ prospective study to determine clinical features, histopathology and treatment outcomes of French patients with IOIS.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed for IOIS
Key inclusion criteria (3 listed)
- Patients with biopsy proven IOIS or presumed IOIS
- Patients with chronic IOS
- Patient with inaugural IOIS or being treated for IOIS
Key exclusion criteria (3 listed)
- Patients who do not fulfill the inclusion criteria
- Patients with systemic disease-associated IOIS
- Incomplete follow-up of patients treated for IOIS
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
Percentage of remission, relapse or resistance among patients with IOIS during the 24 month follow-up
Time frame: The remission, relapse, or the resistance at inclusion (for those previously diagnosed as IOIS), and at 6, 12, 18 and 24 months
Remission: absence of steroids, their withdrawal or their pursuit at a dose ≤ 10 mg/d in the absence of immunosuppressor treatment. Relapse: re initiation of steroids, or their ascension in patients for whom they have been reduced to less than 20 mg/d. Resistance: inability to reduce steroids at an effective dose ≤ 20 mg/d.
6 secondary outcomes
Histopathological classification of IOIS patients
Time frame: at diagnostic
Ophthalmologic features (laterality, pain, visual acuity, eye movement and eyelid)
Time frame: at diagnosis and in case of remission, or relapse, or resistance
MRI features (muscle enlargement, irregular borders, extension to the orbital fat, enhancement around globe) of patients with IOIS
Time frame: at diagnosis and in case of remission, or relapse, or resistance.
Immunologic features of IOIS patients
Time frame: at inclusion
Cumulated dose of prednisone
Time frame: at remission, or relapse, or resistance
Incidence of orbital lymphomas
Time frame: at 6, 12, 18, 24 months.
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 22 Nov 2021.
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Coronary Arterial Disease (CAD), Coronary Calcification
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.
Sébastien ABAD, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Orbital Ischemic Syndrome and Orbital Pseudotumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 3 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 22 Nov 2021. 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 France. 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?
Percentage of remission, relapse or resistance among patients with IOIS during the 24 month follow-up (time frame: The remission, relapse, or the resistance at inclusion (for those previously diagnosed as IOIS), and at 6, 12, 18 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2021.