TY - JOUR
T1 - Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract
T2 - the FACT trial protocol
AU - Day, Alexander C.
AU - Burr, Jennifer M.
AU - Bunce, Catey
AU - Doré, Caroline J.
AU - Sylvestre, Yvonne
AU - Wormald, Richard P. L.
AU - Round, Jeff
AU - McCudden, Victoria
AU - Rubin, Gary
AU - Wilkins, Mark R.
AU - FACT Group
N1 - The study is supported by a grant from the National Institute for Health (NIHR) Health and Technologies Assessment (HTA) programme (reference 13/04/46). The corneal endothelial cell counter used at the Moorfields St Ann's Hospital site was purchased by a grant from the Special Trustees of Moorfields Eye Hospital (reference ST1503D).
PY - 2015/11/27
Y1 - 2015/11/27
N2 - IntroductionCataract 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 and analysis808 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.Ethics and disseminationResearch 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.Trial registration number:ISRCTN: 77602616.
AB - IntroductionCataract 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 and analysis808 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.Ethics and disseminationResearch 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.Trial registration number:ISRCTN: 77602616.
KW - Laser assisted cataract surgery
KW - Phaecoemulsification cataract surgery
KW - randomised controlled trial
U2 - 10.1136/bmjopen-2015-010381
DO - 10.1136/bmjopen-2015-010381
M3 - Article
C2 - 26614627
SN - 2044-6055
VL - 5
SP - 1
EP - 9
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e010381
ER -