The ENHANSE study
Research type
Research Study
Full title
The effect of infusion pressure on the outcomes of phacoemulsification surgery; the ENHANSE study
IRAS ID
288743
Contact name
David Steel
Contact email
Sponsor organisation
South Tyneside and Sunderland NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A new cataract extraction system (Centurion phacoemulsification system with active sentry, Alcon, Fort Worth, USA) allows efficient cataract surgery with safe use of high vacuums, whilst allowing low and physiological infusion pressures, significantly lower than other existing surgical systems and the pressures currently used during surgery. There are reasons to expect that this will lead to patient benefit but it is uncertain if low infusion pressure during cataract surgery will lead to improved outcomes. This is of particular interest in patients undergoing cataract surgery who also have diseases affecting the retina blood vessels such as diabetic retinopathy, as well as glaucoma and other optic nerve diseases where there is established nerve fibre loss in the optic nerve who are also known to be more at risk from raised intraocular pressure.
We propose a feasibility study with a single centre, two surgeon RCT of 70 patients with diabetic retinopathy and/or glaucoma undergoing phacoemulsification with randomisation of two different infusion pressures (low/physiological versus high/normal) using the active sentry system with assessment of a range of exploratory endpoints of the retina before and after the surgery.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0278
Date of REC Opinion
11 Dec 2020
REC opinion
Unfavourable Opinion