IgG4-related Orbital Disease (IgG4-ROD)
Research type
Research Study
Full title
IgG4-related Orbital Disease (IgG4-ROD): A Surveillance Study
IRAS ID
258813
Contact name
Samantha Hunt
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This project aims to examine the incidence, case mix, and current management of patients treated in Britain for ‘probable’ or ‘definite’ orbital IgG4-related disease. We hope to identify factors that might lead to an increased risk of severe, or relapsing disease, and whether there are any links between the orbital and systemic forms of the disease. We hope this might be used to help risk assess and manage patients in the future. Furthermore, we hope that the study will raise awareness of a relatively newly recognised disorder, that may previously have been labelled as ‘idiopathic orbital inflammatory disease’ so that this subset of patients can be appropriately identified and managed. The study does not affect patient management.
Cases will be identified via the British Ophthalmological Surveillance Unit (BOSU) rare disease reporting system as operated by the Royal College of Ophthalmologists over a one year period. Each month, every clinically autonomous ophthalmologist in the UK receives a report card including definitions of each condition currently under surveillance. The 2012 international consensus criteria for orbital IgG4-related disease will be used (see link https://www.orpha.net/data/patho/Pro/en/IgG4_DiagnosticCriteria_En.pdf). Respondents indicate how many cases of each condition they have seen. BOSU informs the investigators of which ophthalmologists have reported new patients with this disease. The researcher (Samantha Hunt) sends data collection proformas directly to the clinician, initially and at one year. The information captured by the allows confirmation of the diagnosis, and establishes clinical features at presentation and management and outcome after 12 months.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0209
Date of REC Opinion
26 Sep 2019
REC opinion
Favourable Opinion