Thermal retinal injury: discovering the risk of handheld laser devices
Research type
Research Study
Full title
Retinal injuries resulting from handheld laser devices: Incidence and epidemiology
IRAS ID
226468
Contact name
Ruth Darbyshire
Contact email
Sponsor organisation
Leeds Teaching Hospitals Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Retinal injuries resulting from laser devices are an avoidable cause of permanent visual deficit. Although rare, case reports and series suggest the estimated incidence of such cases in the UK is increasing. Laser devices are freely available to purchase online or abroad and their sale is largely unregulated. It is a public safety concern that these devices are widely available to the population who are not aware of their potentially devastating effect on vision.\n\nThis study, co-ordinated by the British Ophthalmological Surveillance Unit (BOSU), will be the first of its kind to establish the UK annual incidence of laser-related retinal injuries. Further information on symptoms, clinical signs, natural history, prognosis and complication rates will be collected. The information generated could support legislative changes to the manufacture and sale of laser devices as well as informing the need for future public health campaigns. \n\nInvestigators will send a questionnaire to the reporting clinician to gather data previously generated from the healthcare episode. The study will not place any onus or burden on the patient, who will not be contacted by the investigators or reporting clinician. \n\nThe research work will be carried out at one site-St James University Hospital, Leeds. Clinicians are only required to fill out a data collection proforma seeking clinical information available from the hospital notes of patients who meet the case definition: any patient with a retinal lesion consistent with a thermal injury. There may be a known history of exposure to a laser device but cases with no corroborating history but high index of suspicion will be included. \n\nCollaborators do not need to carry out any procedures mentioned in point 4.25 of the Standard Operating Procedures for ethic committees in the United Kingdom which require a principal investigator to be appointed at each site.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0160
Date of REC Opinion
9 Dec 2019
REC opinion
Further Information Favourable Opinion