Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial

Alexander C. Day; Jennifer M. Burr; Kate Bennett; Catey Bunce; Caroline J. Doré; Gary S. Rubin; Mayank A. Nanavaty; Kamaljit S. Balaggan; Mark R. Wilkins; Francesco Aiello; Muna Ali; Bruce Allan; Hayley Boston; Torsten Chandler; Sandeep Dhallu; Ahmed Elkarmouty; Joanna Gambell; Rachael Hunter; Felicia Ikeji; Balasubramaniam Ilango; Emma Jones; Gemma Jones; John Koshy; Nicola Lau; Vincenzo Maurino; Kirithika Muthusamy; Jeffrey Round; Jasmin Singh; Yvonne Sylvestre; Richard Wormald; Yit Yang

doi:10.1016/j.ophtha.2020.02.028

Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial

Alexander C. Day^*, Jennifer M. Burr, Kate Bennett, Catey Bunce, Caroline J. Doré, Gary S. Rubin, Mayank A. Nanavaty, Kamaljit S. Balaggan, Mark R. Wilkins, Francesco Aiello, Muna Ali, Bruce Allan, Hayley Boston, Torsten Chandler, Sandeep Dhallu, Ahmed Elkarmouty, Joanna Gambell, Rachael Hunter, Felicia Ikeji, Balasubramaniam IlangoEmma Jones, Gemma Jones, John Koshy, Nicola Lau, Vincenzo Maurino, Kirithika Muthusamy, Jeffrey Round, Jasmin Singh, Yvonne Sylvestre, Richard Wormald, Yit Yang

^*Corresponding author for this work

Population Health Sciences

Research output: Contribution to journal › Article › peer-review

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Abstract

Purpose: To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS). Design: Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/). Participants: Seven hundred eighty-five patients with age-related cataract. Methods: This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616. Main Outcome Measures: We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was −0.01 logMAR (−0.05 to 0.03), and mean corrected distance visual acuity difference was −0.01 logMAR (95% confidence interval [CI], −0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome. Conclusions: Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.

Original language	English
Pages (from-to)	1012-1019
Number of pages	8
Journal	Ophthalmology
Volume	127
Issue number	8
DOIs	https://doi.org/10.1016/j.ophtha.2020.02.028
Publication status	Published - Aug 2020

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10.1016/j.ophtha.2020.02.028

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Day, A. C., Burr, J. M., Bennett, K., Bunce, C., Doré, C. J., Rubin, G. S., Nanavaty, M. A., Balaggan, K. S., Wilkins, M. R., Aiello, F., Ali, M., Allan, B., Boston, H., Chandler, T., Dhallu, S., Elkarmouty, A., Gambell, J., Hunter, R., Ikeji, F., ... Yang, Y. (2020). Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial. Ophthalmology, 127(8), 1012-1019. https://doi.org/10.1016/j.ophtha.2020.02.028

@article{b1aafa3df3e4400fa0bcc94a755bf426,

title = "Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial",

abstract = "Purpose: To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS). Design: Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/). Participants: Seven hundred eighty-five patients with age-related cataract. Methods: This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616. Main Outcome Measures: We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was −0.01 logMAR (−0.05 to 0.03), and mean corrected distance visual acuity difference was −0.01 logMAR (95% confidence interval [CI], −0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome. Conclusions: Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.",

author = "Day, {Alexander C.} and Burr, {Jennifer M.} and Kate Bennett and Catey Bunce and Dor{\'e}, {Caroline J.} and Rubin, {Gary S.} and Nanavaty, {Mayank A.} and Balaggan, {Kamaljit S.} and Wilkins, {Mark R.} and Francesco Aiello and Muna Ali and Bruce Allan and Hayley Boston and Torsten Chandler and Sandeep Dhallu and Ahmed Elkarmouty and Joanna Gambell and Rachael Hunter and Felicia Ikeji and Balasubramaniam Ilango and Emma Jones and Gemma Jones and John Koshy and Nicola Lau and Vincenzo Maurino and Kirithika Muthusamy and Jeffrey Round and Jasmin Singh and Yvonne Sylvestre and Richard Wormald and Yit Yang",

year = "2020",

month = aug,

doi = "10.1016/j.ophtha.2020.02.028",

language = "English",

volume = "127",

pages = "1012--1019",

journal = "Ophthalmology",

issn = "0161-6420",

publisher = "Elsevier Inc.",

number = "8",

}

Day, AC, Burr, JM, Bennett, K, Bunce, C, Doré, CJ, Rubin, GS, Nanavaty, MA, Balaggan, KS, Wilkins, MR, Aiello, F, Ali, M, Allan, B, Boston, H, Chandler, T, Dhallu, S, Elkarmouty, A, Gambell, J, Hunter, R, Ikeji, F, Ilango, B, Jones, E, Jones, G, Koshy, J, Lau, N, Maurino, V, Muthusamy, K, Round, J, Singh, J, Sylvestre, Y, Wormald, R & Yang, Y 2020, 'Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial', Ophthalmology, vol. 127, no. 8, pp. 1012-1019. https://doi.org/10.1016/j.ophtha.2020.02.028

TY - JOUR

T1 - Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT)

T2 - A Randomized Noninferiority Trial

AU - Day, Alexander C.

AU - Burr, Jennifer M.

AU - Bennett, Kate

AU - Bunce, Catey

AU - Doré, Caroline J.

AU - Rubin, Gary S.

AU - Nanavaty, Mayank A.

AU - Balaggan, Kamaljit S.

AU - Wilkins, Mark R.

AU - Aiello, Francesco

AU - Ali, Muna

AU - Allan, Bruce

AU - Boston, Hayley

AU - Chandler, Torsten

AU - Dhallu, Sandeep

AU - Elkarmouty, Ahmed

AU - Gambell, Joanna

AU - Hunter, Rachael

AU - Ikeji, Felicia

AU - Ilango, Balasubramaniam

AU - Jones, Emma

AU - Jones, Gemma

AU - Koshy, John

AU - Lau, Nicola

AU - Maurino, Vincenzo

AU - Muthusamy, Kirithika

AU - Round, Jeffrey

AU - Singh, Jasmin

AU - Sylvestre, Yvonne

AU - Wormald, Richard

AU - Yang, Yit

PY - 2020/8

Y1 - 2020/8

N2 - Purpose: To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS). Design: Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/). Participants: Seven hundred eighty-five patients with age-related cataract. Methods: This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616. Main Outcome Measures: We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was −0.01 logMAR (−0.05 to 0.03), and mean corrected distance visual acuity difference was −0.01 logMAR (95% confidence interval [CI], −0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome. Conclusions: Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.

AB - Purpose: To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS). Design: Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/). Participants: Seven hundred eighty-five patients with age-related cataract. Methods: This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616. Main Outcome Measures: We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was −0.01 logMAR (−0.05 to 0.03), and mean corrected distance visual acuity difference was −0.01 logMAR (95% confidence interval [CI], −0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome. Conclusions: Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.

UR - http://www.scopus.com/inward/record.url?scp=85088608361&partnerID=8YFLogxK

U2 - 10.1016/j.ophtha.2020.02.028

DO - 10.1016/j.ophtha.2020.02.028

M3 - Article

C2 - 32386810

AN - SCOPUS:85088608361

SN - 0161-6420

VL - 127

SP - 1012

EP - 1019

JO - Ophthalmology

JF - Ophthalmology

IS - 8

ER -

Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial

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