FACT: laser-assisted versus standard ultrasound cataract surgery
| ISRCTN | ISRCTN77602616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77602616 |
| Secondary identifying numbers | 14/0609; HTA 13/04/46 |
- Submission date
- 28/11/2014
- Registration date
- 06/01/2015
- Last edited
- 01/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
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 (ctu.fact@ucl.ac.uk)
Mark Wilkins (mark.wilkins@moorfields.nhs.uk)
Alex Day (alex.day@ucl.ac.uk)
Contact information
Public
University College London Comprehensive Clinical Trials Unit
Gower Street
London
WC1E 6BT
United Kingdom
| Phone | +44 (0)207 679 6154 |
|---|---|
| ctu.fact@ucl.ac.uk |
Scientific
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
Study information
| Study design | Pragmatic randomised controlled non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The FACT trial: a randomised comparison of Femtosecond laser-assisted vs. manual phacoemulsification CataracT surgery for adults with visually significant cataract |
| Study acronym | FACT |
| Study hypothesis | The trial is a pragmatic, randomised controlled non-inferiority trial to determine if the proposed advantages of laser-assisted cataract surgery translates to real benefits for both patients and the NHS. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/130446 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0017/130670/PRO-13-04-46.pdf |
| Ethics approval(s) | NRES Committee London - City Road & Hampstead, 06/02/2015, ref: 14/LO/1937 |
| Condition | Symptomatic age-related cataract |
| Intervention | Arm A: manual phacoemulsification cataract surgery in the study eye Arm B: laser-assisted phacoemulsification cataract surgery in the study eye |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Unaided distance visual acuity (UDVA, logMAR) at 3 months following surgery in the study eye measured using a standard ETDRS chart at a distance of 4 metres |
| Secondary outcome measures | 1. Unaided distance visual acuity (UDVA) in the study eye at 12 months after surgery 2. Corrected distance visual acuity (logMAR) at 3 and 12 months after surgery in the study eye (ETDRS logMAR chart at 4 metres) 3. Ocular complications within 3 and 12 months of surgery in the study eye (and second eye). A complication will be defined as any event that causes unintentional injury to an ocular structure, or requires additional treatment, or has a negative effect on a patient's health or eyesight 4. Unaided and corrected visual distance acuity and complications in the second eye (for those with bilateral cataracts), and with both eyes open at 3 and 12 months after surgery 5. Percentage of patients within 0.5 and within 1 dioptre of intended refractive outcome 6. Patient-reported outcomes measures: vision health status using Rasch validated patient-reported outcome measures at 3 and 12 months: (Catquest-9SF) 7. Cost-utility analysis: within-trial cost-effectiveness analyses at 3 and 12 months and expected cost- effectiveness over patient lifetime. The analysis will conform to accepted economic evaluation methods and will use the EQ-5D-3L+vision bolt-on question (EQ-5DV) 8. Corneal endothelial cell count change (additional safety measure) at 3 and 12 months |
| Overall study start date | 01/09/2014 |
| Overall study end date | 28/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 808 |
| Total final enrolment | 785 |
| Participant inclusion criteria | 1. Adults aged 18 or over with symptomatic age-related cataract, one or both eyes 2. Patients must be sufficiently fluent in English to provide informed consent and completion of the patient-reported outcome measures 3. Patients must be willing to attend for follow up at 3 and 12 months after first eye cataract surgery |
| Participant exclusion criteria | 1. Secondary causes of cataract 2. Previous cataract, corneal or glaucoma surgery 3. Patient unable to give consent or unable to attend follow-up assessment 4. Patient unable to be positioned for surgery 5. Patient scheduled to undergo combined surgery, e.g. cataract and trabeculectomy 6. Previously identified poor pupil dilation 7. Post-operative intended refractive target is not between (+0.50 and -0.50 dioptres) for the study eye |
| Recruitment start date | 01/05/2015 |
| Recruitment end date | 31/08/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
N15 3TH
United Kingdom
Heath Road
Wolverhampton
WV10 0QP
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Protocol - to be published as soon as final ethics approval is confirmed Results - presented at conferences and published from early 2017 onwards |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/11/2015 | Yes | No | |
| Results article | results | 01/08/2020 | 11/05/2020 | Yes | No |
| Results article | results | 01/01/2021 | 01/02/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/02/2021: Publication reference added.
11/05/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
26/11/2018: No publications found, verifying study status with principal investigator.
30/11/2015: Publication reference added.
