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Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery (FACT): a randomised non-inferiority trial, 1 year outcomes

Day, AC; Burr, JM; Bennett, K; Doré, CJ; Bunce, C; Hunter, R; Nanavaty, MA; ... FACT trial group¢; + view all (2020) Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery (FACT): a randomised non-inferiority trial, 1 year outcomes. Journal of Cataract and Refractive Surgery 10.1097/j.jcrs.0000000000000257. (In press). Green open access

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Abstract

PURPOSE: To report the 1 year outcomes of a randomised trial comparing femtosecond laser assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS). SETTING: Moorfields Eye Hospital, New Cross Hospital and Sussex Eye Hospital, UK DESIGN:: Multicentre, randomised controlled non inferiority trial. METHODS: 311 of 392 (79%) participants allocated to FLACS and 292 of 393 (74%) participants allocated to PCS attended follow-up at 1 year. Postoperative assessments were masked to the allocated intervention. Outcomes included UDVA, CDVA, complications, corneal endothelial cell count and patient reported outcomes measures. ISRCTN77602616. RESULTS: Mean UDVA was 0.14 (SD 0.22) for FLACS and 0.17 (0.25) for PCS with difference between treatment arms of -0.03 logMAR (95% CI: -0.06 to 0.01, p=0.17). Mean CDVA was 0.003 (0.18) for FLACS and 0.03 (0.23) for PCS with difference of -0.03 logMAR (95% CI -0.06 to 0.01, p=0.11). 75% of both FLACS (230/307) and PCS (218/290) cases were within ±0.5D refractive target, and 95% FLACS (292/307) and 96% PCS (279/290) cases within ±1.0D. There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR (p=0.036) favouring FLACS. The mean cost difference was £167.62 per patient greater for FLACS (95% of iterations between -£14.12 and £341.67). CONCLUSIONS: PCS is not inferior to FLACS in terms of vision, patient reported health and safety outcomes after one year follow-up. A difference was found for binocular CDVA, which whilst statistically significant, was not clinically important. FLACS is not cost effective.

Type: Article
Title: Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery (FACT): a randomised non-inferiority trial, 1 year outcomes
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1097/j.jcrs.0000000000000257
Publisher version: http://dx.doi.org/10.1097/j.jcrs.0000000000000257
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Ophthalmology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > Comprehensive CTU at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health
URI: https://discovery.ucl.ac.uk/id/eprint/10107868
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