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dc.contributor.authorDay, Alexander C
dc.contributor.authorBurr, Jennifer M
dc.contributor.authorBennett, Kate
dc.contributor.authorHunter, Rachael
dc.contributor.authorBunce, Catey
dc.contributor.authorDoré, Caroline J
dc.contributor.authorNanavaty, Mayank A
dc.contributor.authorBalaggan, Kamaljit S
dc.contributor.authorWilkins, Mark R
dc.date.accessioned2021-03-02T11:30:42Z
dc.date.available2021-03-02T11:30:42Z
dc.date.issued2021-01-01
dc.identifier.citationDay , A C , Burr , J M , Bennett , K , Hunter , R , Bunce , C , Doré , C J , Nanavaty , M A , Balaggan , K S & Wilkins , M R 2021 , ' Femtosecond laser-assisted cataract surgery compared with phacoemulsification : the FACT non-inferiority RCT ' , Health Technology Assessment , vol. 25 , no. 6 , pp. 1-68 . https://doi.org/10.3310/hta25060en
dc.identifier.issn1366-5278
dc.identifier.otherPURE: 272790558
dc.identifier.otherPURE UUID: 7e34c70c-394c-44bc-9be4-d1365c1bd86f
dc.identifier.otherJisc: dee67516eda041f38d64cb7f50933d6a
dc.identifier.otherORCID: /0000-0002-9478-738X/work/88731013
dc.identifier.otherScopus: 85100546096
dc.identifier.otherWOS: 000614040800001
dc.identifier.urihttp://hdl.handle.net/10023/21536
dc.descriptionFunding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used).en
dc.description.abstractBackground  Cataract surgery is one of the most common operations. Femtosecond laser-assisted cataract surgery (FLACS) is a technique that automates a number of operative steps.  Objectives  To compare FLACS with phacoemulsification cataract surgery (PCS).  Design  Multicentre, outcome-masked, randomised controlled non-inferiority trial.  Setting Three collaborating NHS hospitals.  Participants  A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017.  Intervention FLACS (n = 392 participants) or PCS (n = 393 participants).  Main outcome measures The primary outcome was uncorrected distance visual acuity in the study eye after 3 months, expressed as the logarithm of the minimum angle of resolution (logMAR): 0.00 logMAR (or 6/6 if expressed in Snellen) is normal (good visual acuity). Secondary outcomes included corrected distance visual acuity, refractive outcomes (within 0.5 dioptre and 1.0 dioptre of target), safety and patient-reported outcome measures at 3 and 12 months, and resource use. All trial follow-ups were performed by optometrists who were masked to the trial intervention.  Results A total of 353 (90%) participants allocated to the FLACS arm and 317 (81%) participants allocated to the PCS arm attended follow-up at 3 months. The mean uncorrected distance visual acuity was similar in both treatment arms [0.13 logMAR, standard deviation 0.23 logMAR, for FLACS, vs. 0.14 logMAR, standard deviation 0.27 logMAR, for PCS, with a difference of –0.01 logMAR (95% confidence interval –0.05 to 0.03 logMAR; p = 0.63)]. The mean corrected distance visual acuity values were again similar in both treatment arms (–0.01 logMAR, standard deviation 0.19 logMAR FLACS vs. 0.01 logMAR, standard deviation 0.21 logMAR PCS; p = 0.34). There were two posterior capsule tears in the PCS arm. There were no significant differences between the treatment arms for any secondary outcome at 3 months. At 12 months, the mean uncorrected distance visual acuity was 0.14 logMAR (standard deviation 0.22 logMAR) for FLACS and 0.17 logMAR (standard deviation 0.25 logMAR) for PCS, with a difference between the treatment arms of –0.03 logMAR (95% confidence interval –0.06 to 0.01 logMAR; p = 0.17). The mean corrected distance visual acuity was 0.003 logMAR (standard deviation 0.18 logMAR) for FLACS and 0.03 logMAR (standard deviation 0.23 logMAR) for PCS, with a difference of –0.03 logMAR (95% confidence interval –0.06 to 0.01 logMAR; p = 0.11). There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of –0.02 logMAR (95% confidence interval –0.05 to 0.00 logMAR) (p = 0.036), which favoured FLACS. There were no significant differences between the arms for any health, social care or societal costs. For the economic evaluation, the mean cost difference was £167.62 per patient higher for FLACS (95% of iterations between –£14.12 and £341.67) than for PCS. The mean QALY difference (FLACS minus PCS) was 0.001 (95% of iterations between –0.011 and 0.015), which equates to an incremental cost-effectiveness ratio (cost difference divided by QALY difference) of £167,620.  Limitations Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked.  Conclusions The evidence suggests that FLACS is not inferior to PCS in terms of vision after 3 months’ follow-up, and there were no significant differences in patient-reported health and safety outcomes after 12 months’ follow-up. In addition, the statistically significant difference in binocular corrected distance visual acuity was not clinically significant. FLACS is not cost-effective.  Future work To explore the possible differences in vision in patients without ocular co-pathology. 
dc.format.extent68
dc.language.isoeng
dc.relation.ispartofHealth Technology Assessmenten
dc.rightsCopyright © Queen’s Printer and Controller of HMSO 2021. This work was produced by Day et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.en
dc.subjectHealth Policyen
dc.subjectRD Surgeryen
dc.subjectRE Ophthalmologyen
dc.subject3rd-DASen
dc.subject.lccRDen
dc.subject.lccREen
dc.titleFemtosecond laser-assisted cataract surgery compared with phacoemulsification : the FACT non-inferiority RCTen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Population and Behavioural Science Divisionen
dc.identifier.doihttps://doi.org/10.3310/hta25060
dc.description.statusPeer revieweden


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