Phenotyping in cicatricial conjunctivitis v1.0
Research type
Research Study
Full title
Clinical and genetic phenotyping in cicatricial (scarring) conjunctivitis: an observational case series.
IRAS ID
202723
Contact name
John Dart
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
In the United Kingdom mucous membrane pemphigoid (MMP), Stevens-Johnson syndrome (SJS) and atopic keratoconjunctivitis (AKC) are the most common causes of cicatricial (scarring) conjunctivitis. These are a group of diseases that cause inflammation and scarring of the conjunctiva. They are life-long once acquired and can be debilitating, painful diseases leading to bilateral blindness in 20% of patients.
The processes that result in inflammation and scarring in cicatricial conjunctivitis are poorly understood. Consequently, they have a relatively poor response to current therapies. There is also no validated clinical system for measuring the severity and activity of disease in cicatricial conjunctivitis.
This study aims to validate a clinical report form for use as a standardised assessment tool to measure the severity and activity of cicatricial conjunctivitis. This tool can be used in planned therapeutic studies of cicatricial conjunctivitis.
This tool will include in vivo confocal microscopy (IVCM), a non-invasive technique for imaging at the cellular level used to grade ocular surface scarring. It will also include taking a swab from the conjunctiva to assess gene expression, a rapid non-invasive method of identifying genes involved in scarring and inflammatory pathways that can be used as biomarkers for these disease processes. A second swab will be taken to detect and identify bacterial species through DNA deep sequencing to detect and identify bacteria. This allows evaluation of the conjunctival microbiome of study patients which can be altered in cicatricial conjunctivitis and thus act as important biomarkers of disease.
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/0674
Date of REC Opinion
12 Apr 2016
REC opinion
Favourable Opinion