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

• Published in: BMJ open Vol. 5; no. 11; p. e010381
• Main Authors: Day, Alexander C, Burr, Jennifer M, Bunce, Catey, Doré, Caroline J, Sylvestre, Yvonne, Wormald, Richard P L, Round, Jeff, McCudden, Victoria, Rubin, Gary, Wilkins, Mark R
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 27-11-2015; BMJ Publishing Group
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Astigmatism; Cataract - therapy; Cataract Extraction - methods; Cataracts; Cornea; Cost analysis; Diabetic retinopathy; Eye surgery; Female; Health services; Humans; Intervention; Laser Therapy - methods; Lasers; Male; Medical personnel; Middle Aged; Ophthalmology; Patients; Phacoemulsification - methods; Prospective Studies; Quality of life; Reproducibility of Results; Research Design; Single-Blind Method; Transplants & implants; Treatment Outcome; United Kingdom; Visual Acuity - physiology; Young Adult; United Kingdom > UK; Laser assisted cataract surgery; Phacoemulsification cataract surgery; Randomised controlled trial
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2015-010381

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 numberISRCTN: 77602616.