Clinical trial NCT01443000: Survey of Patients With Idiopathic Orbital Inflammation Syndrome
Official title: Survey of Patients With Idiopathic Orbital Inflammation Syndrome (IOIS): Clinical, Morphological and Pathological Features and Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Ischemic Syndrome
Orbital Pseudotumor
Keywords: Observational study
IOIS
Orbital Pseudotumor
Outcome
Treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-09-29
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for IOIS

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy proven IOIS or presumed IOIS
* Patients with chronic IOS
* Patient with inaugural IOIS or being treated for IOIS

Exclusion Criteria:

* Patients who do not fulfill the inclusion criteria
* Patients with systemic disease-associated IOIS
* Incomplete follow-up of patients treated for IOIS

Primary outcomes:
measure: Percentage of remission, relapse or resistance among patients with IOIS during the 24 month follow-up
timeFrame: The remission, relapse, or the resistance at inclusion (for those previously diagnosed as IOIS), and at 6, 12, 18 and 24 months
Secondary outcomes:
measure: Histopathological classification of IOIS patients
timeFrame: at diagnostic
measure: Ophthalmologic features (laterality, pain, visual acuity, eye movement and eyelid)
timeFrame: at diagnosis and in case of remission, or relapse, or resistance
measure: MRI features (muscle enlargement, irregular borders, extension to the orbital fat, enhancement around globe) of patients with IOIS
timeFrame: at diagnosis and in case of remission, or relapse, or resistance.
measure: Immunologic features of IOIS patients
timeFrame: at inclusion
measure: Cumulated dose of prednisone
timeFrame: at remission, or relapse, or resistance
measure: Incidence of orbital lymphomas
timeFrame: at 6, 12, 18, 24 months.
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Service de Médecine interne - Hôpital Avicenne
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sébastien ABAD, MD
role: PRINCIPAL_INVESTIGATOR
References: