Incidence Study of Clinically Significant Structural Hypotony in UK
Research type
Research Study
Full title
The Incidence, Risk Factors and Examination Findings of Clinically Significant Structural Hypotony in the United Kingdom
IRAS ID
335705
Contact name
Rana Khalil
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This epidemiological study will aim to establish a current incidence rate for patients with clinically significant ocular hypotony. Prospective case ascertainment will be undertaken through the British Ophthalmological Surveillance Unit (BOSU) monthly reporting system. This is an active surveillance system involving all UK consultant and trainee ophthalmologists. This epidemiological study will only be using information available from the patient case notes. Ophthalmologists will indicate that they have seen a new case through the BOSU and then data collection will be undertaken within a specific online platform using the data safe haven at University of Dundee.
The research work will be carried out at two sites (Gartnavel General Hospital and Moorfields Eye Hospital), with the data held in the data safe haven at the Health Information Centre University of Dundee. Local collaborators are only required to fill out the data collection proforma seeking clinical information available from the hospital notes of patients who have been notified as suffering sight loss due to structural hypotony. They do not need to carry out any procedures mentioned in the Standard Operating Procedures for ethics committees in the United Kingdom which require a principal investigator to be appointed at each site. Analysis will be descriptive and all findings reported in an aggregated format and at no point will the patients routine standard care be altered or impacted as a result of this study.
The data will never leave the safe haven, once analysed aggregated tables and graphs will be produced in a format suitable for publication in peer review journals.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
24/PR/0784
Date of REC Opinion
14 Jan 2025
REC opinion
Further Information Favourable Opinion