Survey of Patients With Idiopathic Orbital Inflammation Syndrome

NCT01443000 | Completed

• 2 other identifiers: NI080142010-A00512-37
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Orbital Ischemic Syndrome; Orbital Pseudotumor

Keywords

Observational study; IOIS; Orbital Pseudotumor; Outcome; Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  at diagnostic

• Ophthalmologic features (laterality, pain, visual acuity, eye movement and eyelid)

  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

  at diagnosis and in case of remission, or relapse, or resistance.

• Immunologic features of IOIS patients

  at inclusion

• Cumulated dose of prednisone

  at remission, or relapse, or resistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed for IOIS

You may qualify if:

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

You may not qualify if:

• Patients with systemic disease-associated IOIS
• Incomplete follow-up of patients treated for IOIS

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Service de Médecine interne - Hôpital Avicenne

Bobigny, 93000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be frozen to form a serum storage and a DNAthèque. These samples will achieve further analysis based on the evolution of knowledge on mechanisms contributing to the orbital inflammation.

MeSH Terms

Conditions

Orbital Pseudotumor

Condition Hierarchy (Ancestors)

Orbital Diseases; Eye Diseases

Study Officials

• Sébastien ABAD, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: September 29, 2011
• Study Start: March 3, 2012
• Primary Completion: June 3, 2017
• Study Completion: June 3, 2017
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

FR (1)