Survey of Patients With Idiopathic Orbital Inflammation Syndrome (SIOI)
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|ClinicalTrials.gov Identifier: NCT01443000|
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : April 29, 2019
|Condition or disease|
|Orbital Ischemic Syndrome Orbital Pseudotumor|
|Study Type :||Observational|
|Actual Enrollment :||87 participants|
|Official Title:||Survey of Patients With Idiopathic Orbital Inflammation Syndrome (IOIS): Clinical, Morphological and Pathological Features and Treatment Outcomes|
|Actual Study Start Date :||March 3, 2012|
|Actual Primary Completion Date :||June 3, 2017|
|Actual Study Completion Date :||June 3, 2017|
- 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.
- Histopathological classification of IOIS patients [ Time Frame: at diagnostic ]-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.
- Ophthalmologic features (laterality, pain, visual acuity, eye movement and eyelid) [ Time Frame: at diagnosis and in case of remission, or relapse, or resistance ]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.
- 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. ]the lesional topography and the T1/T2 weighted sequences will be studied
- Immunologic features of IOIS patients [ Time Frame: at inclusion ]the IgG4 level and ANA in sera will be assessed
- Cumulated dose of prednisone [ Time Frame: at remission, or relapse, or resistance ]
- Incidence of orbital lymphomas [ Time Frame: at 6, 12, 18, 24 months. ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443000
|Service de Médecine interne - Hôpital Avicenne|
|Bobigny, France, 93000|
|Principal Investigator:||Sébastien ABAD, MD||Assistance Publique - Hôpitaux de Paris|