Infraorbital Nerve Involvement on Magnetic Resonance Imaging in IgG4-related Ophthalmic Disease (RetroG4)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Orbital Infections, Inflammations and Irritations; IgG4-related Disease

Treatments: Other: no intervention (descriptive study)

Study type: Observational

Funder types: NETWORK

Identifiers

NCT03690908

NI_2016_1_ALR

Details and patient eligibility

About

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)

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• 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.

Exclusion criteria :

• 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

Trial design

38 participants in 2 patient groups

IgG4-related orbital inflammation

Description:

patients with orbital inflammation and positive IgG4 immunostaining in orbital biopsy

Treatment:

Other: no intervention (descriptive study)

non IgG4-related orbital inflammation

Description:

patients with orbital inflammation and negative IgG4 immunostaining in orbital biopsy

Treatment:

Other: no intervention (descriptive study)