Extrait

Background and study aims Cataracts are cloudy patches that develop in the lens of the eye and can cause blurred or misty vision. The only treatment that is proven to be effective for cataracts is surgery. Cataract surgery is the most commonly performed operation by the NHS with more than 310,000 operations performed in 2011-12. Cataracts are usually related to older age and as our population is ageing, we can expect the number of cataract operations to increase. While complication rates appear low, patients can be devastated when suffering a complication from surgery and due to the importance of vision for daily activities, can find even relatively minor complications distressing. This is a study comparing two different methods of cataract surgery. The current standard method is done by hand using ultrasound to break up the cataract. We want to compare this to a new technique using a computer-controlled laser system. The potential advantages of laser-assisted cataract surgery are that the steps completed by this method can be performed more precisely, more reliably and faster than they can be done by hand. This should translate to better visual outcomes and better patient safety as a result of fewer complications. The use of lasers in eye surgery is not new, and they have been used for surgery on the cornea (the structure at the front of the eye) for over a decade. Who can participate? Adults aged 18 or over with age-related cataracts in one or both eyes. What does the study involve? Participants will be randomly allocated so that half will have their cataract surgery done using the standard (ultrasound) method, and half will have the new laser-assisted method. The two types of surgery will be compared by looking at visual acuity, visual satisfaction through questionnaires, complications and health economic measures at 3 months following the first eye cataract surgery. What are the possible benefits and risks of participating? We cannot promise that taking part in the study will benefit you, but by taking part you will be helping us find out how laser-assisted cataract surgery compares to the current standard method. The results of the study will help to plan cataract services offered by the NHS. The study findings will provide high quality evidence to 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. Studies to date on laser cataract surgery have reported no overall difference in serious complications when compared to standard ultrasound cataract surgery. Serious complications for both types of surgery are uncommon, but if they do occur they can permanently damage your eye and your vision. For cataract surgery done by either study method, there is an average: 1. One in a thousand risk of severe and permanent visual loss 2. One in a hundred risk of requiring additional surgery to rectify a problem 3. One in twenty risk of less serious complications, which may require further treatment at the time of surgery or following the operation 4. One in ten risk of laser treatment at some time in the future for opacity of the capsule behind the implant There is virtually no risk to the other eye Where is the study run from? The study will be carried out at two sites, one is a Community Hospital in North London (St. Ann's Hospital), and the second is a District General Hospital in the West Midlands (New Cross Hospital, Wolverhampton). When is the study starting and how long is it expected to run for? The study will run from September 2014 to February 2018. Who is funding the study? National Institute for Health Research (NIHR) (UK). Who is the main contact? Vicky McCudden ([email protected]) Mark Wilkins ([email protected]) Alex Day ([email protected])

Critère d'inclusion

• Symptomatic age-related cataract

Liens

• ictrp
• isrctn