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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Vicky McCudden
+44 (0)207 679 6154
ctu.fact@ucl.ac.uk


Mr Mark Wilkins


Study Location:

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Be Part of Research - Trial Details - FACT: laser-assisted versus standard ultrasound cataract surgery
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FACT: laser-assisted versus standard ultrasound cataract surgery

Not Recruiting

Open to: All Genders

Age: Adult

London Wolverhampton

Medical Conditions

Symptomatic age-related cataract

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 May 2015 31 Aug 2016

Publications

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26614627 protocol2020 Results article in https://doi.org/10.1016/j.ophtha.2020.02.028 results (added 11/05/2020)2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33511963/ results (added 01/02/2021)

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.


Adults aged 18 or over with age-related cataracts in one or both eyes.

You can take part if:



You may not be able to take part if:


1. Secondary causes of cataract2. Previous cataract, corneal or glaucoma surgery3. Patient unable to give consent or unable to attend follow-up assessment4. Patient unable to be positioned for surgery5. Patient scheduled to undergo combined surgery, e.g. cataract and trabeculectomy6. Previously identified poor pupil dilation7. Post-operative intended refractive target is not between (+0.50 and -0.50 dioptres) for the study eye


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St. Ann's Hospital
    St. Ann's Road
    London
    N15 3TH
  • New Cross Hospital
    Wednesfield Road Heath Road
    Wolverhampton
    WV10 0QP

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

Mr Mark Wilkins


Ms Vicky McCudden
+44 (0)207 679 6154
ctu.fact@ucl.ac.uk



The study is sponsored by University College London and funded by National Institute for Health Research.



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Read full details for Trial ID: ISRCTN77602616

Or CPMS 17958

Last updated 01 February 2021

This page is to help you find out about a research study and if you may be able to take part

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