FACT

A Randomised, Single Masked, Non-Inferiority Trial of Femtosecond Laser Assisted vs Manual Phacoemulsification Cataract Surgery for Adults with Visually Significant Cataract

Funded by the National Institute of Health Research Health Technology Assessment, FACT is a multi-centre randomised, single masked, non-inferiority trial to compare Femtosecond Laser Assisted and Manual Phacoemulsification Cataract Surgery in adults with visually significant cataract.

Computer controlled laser platforms can automate over half the steps currently completed by hand in cataract surgery. The theoretical advantages of laser assisted cataract surgery include greater safety, better vision and potentially lower long-term health costs through greater efficiency and safety.

The trial will inform NHS service providers, commissioners, patients and ophthalmologists about the effectiveness and cost-effectiveness of these two ways of performing cataract surgery and will help to guide the possible introduction of laser assisted cataract surgery in the NHS.

FACT is now closed.

Publications

• Day AC, Burr JM, Bennett K, Hunter R, Bunce C, Doré CJ, Nanavaty MA, Balaggan KS, Wilkins MR. Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT. Health Technol Assess 2021;25(6).

• Day AC, Burr JM, Bennett K, Doré CJ, Bunce C, Hunter R, Nanavaty MA, Balaggan KS, Wilkins MR, on behalf of the FACT trial group. Femtosecond laser-assisted cataract surgery compared with phacoemulsification surgery (FACT). A randomised non-inferiority trial, 1 year outcomes. Journal of Cataract and Refractive Surgery 2020

• Hakim‐Moulay Dehbi  David M. Lowe  John O'Quigley. Early phase dose‐finding trials in virology Alexander C.Day PhD; Jennifer M.Burr MD; Kate Bennett MSc; Catey Bunce DSc; Caroline J.Doré BSc; Gary S.Rubin PhD; Mayank A.Nanavaty PhD; Kamaljit S.Balaggan PhD; Mark R.Wilkins MD. Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial.

• Alexander C.Day PhD; Jennifer M.Burr MD; Kate Bennett MSc; Catey Bunce DSc; Caroline J.Doré BSc; Gary S.Rubin PhD; Mayank A.Nanavaty PhD; Kamaljit S.Balaggan PhD; Mark R.Wilkins MD. | Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial Ophthalmology Volume 127, Issue 8, August 2020, Pages 1012-1019

• Day AC, Burr JM, Bunce C, Doré CJ, Sylvestre Y, Wormald RPL, Round J, McCudden V, Rubin G, Wilkins MR, on behalf of the FACT Group. 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. BMJ Open 2015; 5:e010381.

ISRCTN77602616