title: Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract: the FACT trial protocol.
abstract: BACKGROUND
  Cataract is one of the leading causes of low vision in the westernised world, and cataract surgery is one of the most commonly performed operations. Laser platforms for cataract surgery are now available, the anticipated advantages of which are broad and may include better visual outcomes through greater precision and reproducibility, and improved safety. FACT is a randomised single masked non-inferiority trial to establish whether laser-assisted cataract surgery is as good as or better than standard manual phacoemulsification.
  
  
  METHODS
  808 patients aged 18 years and over with visually significant cataract will be randomised to manual phacoemulsification cataract surgery (standard care) or laser-assisted cataract surgery (intervention arm). Outcomes will be measured at 3 and 12 months after surgery. The primary clinical outcome is uncorrected distance visual acuity (UDVA, logMAR) at 3 months in the study eye recorded by an observer masked to the trial group. Secondary outcomes include UDVA at 12 months, corrected distance visual acuity at 3 and 12 months, complications, endothelial cell loss, patient-reported outcome measures and a health economic analysis conforming to National Institute for Health and Care Excellence standards.
  
  
  BACKGROUND
  Research Ethics Committee Approval was obtained on 6 February 2015, ref: 14/LO/1937. Current protocol: v2.0 (08/04/2015). Study findings will be published in peer-reviewed journals.
  
  
  BACKGROUND
  
  77602616.
authors.affiliation: UCL Institute of Ophthalmology, University College London, London, UK The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Alexander C
authors.identifier: http://orcid.org/0000-0002-2099-8870
authors.initials: AC
authors.lastname: Day
authors.affiliation: University of St Andrews, Scotland, Fife, UK.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Burr
authors.affiliation: UCL Institute of Ophthalmology, University College London, London, UK The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Catey
authors.identifier: http://orcid.org/0000-0002-0935-3713
authors.initials: C
authors.lastname: Bunce
authors.affiliation: UCL Comprehensive Clinical Trials Unit, London, UK.
authors.forename: Caroline J
authors.initials: CJ
authors.lastname: Doré
authors.affiliation: UCL Comprehensive Clinical Trials Unit, London, UK.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Sylvestre
authors.affiliation: UCL Institute of Ophthalmology, University College London, London, UK The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Richard P L
authors.initials: RP
authors.lastname: Wormald
authors.affiliation: UCL Comprehensive Clinical Trials Unit, London, UK.
authors.forename: Jeff
authors.initials: J
authors.lastname: Round
authors.affiliation: UCL Comprehensive Clinical Trials Unit, London, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: McCudden
authors.affiliation: UCL Institute of Ophthalmology, University College London, London, UK The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Gary
authors.initials: G
authors.lastname: Rubin
authors.affiliation: The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Wilkins
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002386:Cataract / Q000628:therapy*; D002387:Cataract Extraction / Q000379:methods*; D005260:Female; D006801:Humans; D053685:Laser Therapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification / Q000379:methods*; D011446:Prospective Studies; D015203:Reproducibility of Results; D012107:Research Design; D016037:Single-Blind Method; D016896:Treatment Outcome; D006113:United Kingdom; D014792:Visual Acuity / Q000502:physiology*; D055815:Young Adult
keywords: Laser assisted cataract surgery; Phacoemulsification cataract surgery; Randomised controlled trial