EVIAN Study
Research type
Research Study
Full title
Early Vitrectomy and Intravitreal Antibiotics for post-operative exogenous eNdophthalmitis: A feasibility multicentre randomised controlled trial (EVIAN Study)
IRAS ID
282733
Contact name
Mahiul MK Muqit
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
What is this study about?
To assess the feasibility of doing a trial of the benefit of prompt surgery for a rare but blinding bacterial eye infection known as “endophthalmitis” that can complicate any invasive eye procedure. Endophthalmitis causes rapid loss of vision and antibiotic injections into the eye ("intravitreal") may not be sufficient to control the infection. 50% patients need surgery to remove the infected vitreous (vitrectomy) with patients requiring intensive and extended inpatient/outpatient management over a 6-month period. The impact on the well being of patients and their carers, both physically and psychologically, is immense often with severe pain and sight loss, which may or may not recover.How will this study help patients?
Earlier surgery, by removing infected vitreous material at diagnosis, rather than after failure to respond to intravitreal antibiotics, may accelerate recovery from the infection. Early vitrectomy may improve vision recovery, patient well-being, reduce NHS and patient costs with less hospital visits,and assist in endeavours to reduce antibiotic usage.What will we do in this study?
In order to measure the possible benefit of earlier surgery,we need to conduct a feasibility study of a multicentre randomised controlled trial to discover if the trial we are planning is possible in the reality of urgent care management of these people in current NHS environments.Participants will be randomly allocated to vitrectomy performed at an earlier stage of the condition,or later if needs be in accordance with standard care.What do our patients think about the study?
We undertook a focus group with patients who had vitrectomy for endophthalmitis exploring their views and experiences.The consensus was the study was worthwhile.They advised us to approach study patients in an undisturbed environment with nursing support, giving them at least 48 hours to reflect on trial information plan patient advisory group meetings during the study to guide our research.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
20/WM/0264
Date of REC Opinion
24 Nov 2020
REC opinion
Further Information Favourable Opinion