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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03690908

Acronym

RetroG4

Enrollment

Registered

2018-10-01

Start date

2016-03-01

Completion date

2016-12-01

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4-related Disease, Orbital Infections, Inflammations and Irritations

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)

Interventions

OTHERno intervention (descriptive study)

no intervention (descriptive study)

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients with infraorbital nerve involvement in magnetic resonance imaging	Within 2 weeks after the first consultation for orbital inflammation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026