FACT
Research type
Research Study
Full title
A Randomised Comparison of Femtosecond Laser Assisted vs Manual Phacoemulsification Cataract Surgery for Adults with Visually Significant Cataract
IRAS ID
163652
Contact name
Mark Wilkins
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
3 years, 5 months, 28 days
Research summary
Cataract surgery is the most commonly performed operation by the NHS. Cataracts are related to older age and as our population is ageing, we can expect the number of operations to increase.
After cataract surgery, most people who have no previous eye problems achieve the required vision ability for driving and about half achieve ‘normal vision’ ("20/20 vision"). Complications are uncommon, but when they do occur, may be serious resulting in delayed visual recovery and need for further surgery, thus affecting patients' quality of life.
Computer controlled laser systems are available that can automate over half of the steps in cataract surgery and using a laser these steps can be performed more precisely, reliably and faster than by hand. This may result in better outcomes for patients and fewer complications. Lasers have been used in eye surgery for over a decade, but not for cataract surgery until more recently. Worldwide the conversion to laser cataract surgery is rapid and seems to be accelerating despite there being no high quality evidence demonstrating effectiveness or safety compared to the standard cataract operation.
We propose a clinical trial in 808 patients, with half randomly assigned to standard care or laser cataract surgery. We will compare the two types of surgery by looking at measurements of vision, including quality of life questionnaires, complication rates and we will measure cost effectiveness to the NHS.
The trial findings will provide high quality evidence to the NHS service providers, patients and eye specialists about these two methods of cataract surgery and so help guide any possible introduction of laser cataract surgery in the NHS.
REC name
London - Bromley Research Ethics Committee
REC reference
14/LO/1937
Date of REC Opinion
26 Nov 2014
REC opinion
Favourable Opinion