This trial is active, not recruiting.

Conditions orbital ischemic syndrome, orbital pseudotumor
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Ministry of Health, France
Start date March 2012
End date June 2017
Trial size 87 participants
Trial identifier NCT01443000, 2010-A00512-37, NI08014


The purpose of this study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

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

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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Survey of Patients With Idiopathic Orbital Inflammation Syndrome (IOIS): Clinical, Morphological and Pathological Features and Treatment Outcomes
Principal investigator Sébastien ABAD, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.