Infraorbital Nerve Involvement on Magnetic Resonance Imaging in IgG4-related Ophthalmic Disease

NCT03690908 | Completed

• 1 other identifier: NI_2016_1_ALR
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. This study aims at comparing the frequency of IONE in patients suffering from IgG4-related ophthalmic disease (IgG4-ROD) versus patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD)

Conditions

IgG4-related Disease; Orbital Infections, Inflammations and Irritations

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with infraorbital nerve involvement in magnetic resonance imaging

  Within 2 weeks after the first consultation for orbital inflammation

Study Arms (2)

IgG4-related orbital inflammation

patients with orbital inflammation and positive IgG4 immunostaining in orbital biopsy

Other: no intervention (descriptive study)

non IgG4-related orbital inflammation

patients with orbital inflammation and negative IgG4 immunostaining in orbital biopsy

Other: no intervention (descriptive study)

Interventions

no intervention (descriptive study) OTHER

no intervention (descriptive study)

IgG4-related orbital inflammation; non IgG4-related orbital inflammation

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

All adult patients suffering from non-thyroid, non-lymphoma related orbital inflammation treated in Fondation Rothschild (tertiary ophtalmology facility, Paris, France) from January 2006 through April 2015.

You may qualify if:

• Patient aged 18 and older treated in Fondation Rothschild (tertiary ophthalmology facility, Paris, France) from January 2006 through April 2015
• Presence of a clinical orbital inflammation: mass/swelling, pain, exophthalmos, visual loss, ptosis, or diplopia.
• The presence of at least one pretherapeutic MRI confirming the inflammation of one or more orbital structures: the lacrimal gland, fat, muscles, or infraorbital nerve. The mandatory minimal MRI protocol include the following sequences: T1- and T2-weighted MRI image, in the transverse and coronal plane, and a fat-suppressed T1-weighted image in the coronal plane obtained after intravenous administration of a gadolinium chelate.
• Completion of at least one orbital biopsy with a pathologic examination and an immunohistochemical screen for IgG4.

You may not qualify if:

• Clinical and biological signs of thyroid-associated orbitopathy
• Histologically proven lymphoma
• Pretherapeutic MRI that is insufficient for an adequate interpretation
• Absence of IgG4 testing in the pathology examination

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease; Inflammation

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 1, 2018
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)