PCIOL exchange or explantation study
Research type
Research Study
Full title
Posterior chamber intraocular lens (PCIOL) exchange or explantation following primary cataract surgery for any indication.
IRAS ID
338484
Contact name
Mohaimen Al-Zubaidy
Contact email
Sponsor organisation
SOUTH TYNESIDE AND SUNDERLAND NHS FOUNDATION TRUST
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
This epidemiological study will aim to establish a current incidence rate for patients with posterior chamber intraocular lens (PCIOL) exchange or explantation following primary cataract surgery for any indication. 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 one site (Sunderland Eye Infirmary), with the data held in the data safe haven at the Health Infomation 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 dely. 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/LO/0872
Date of REC Opinion
11 Dec 2024
REC opinion
Favourable Opinion