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Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT.
Health Technol Assess. 2021 01; 25(6):1-68.HT

Abstract

BACKGROUND

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.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN77602616.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 6. See the NIHR Journals Library website for further project information. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used).

Authors+Show Affiliations

The National Institute for Health Research (NIHR) Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK. Moorfields Eye Hospital, London, UK. University College London (UCL) Institute of Ophthalmology, London, UK.School of Medicine, University of St Andrews, St Andrews, UK.UCL Comprehensive Clinical Trials Unit (CCTU), London, UK.UCL Comprehensive Clinical Trials Unit (CCTU), London, UK.Department of Primary Care and Public Health Sciences, King's College London, London, UK.UCL Comprehensive Clinical Trials Unit (CCTU), London, UK.Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, UK.The National Institute for Health Research (NIHR) Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK. Moorfields Eye Hospital, London, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33511963

Citation

Day, Alexander C., et al. "Femtosecond Laser-assisted Cataract Surgery Compared With Phacoemulsification: the FACT Non-inferiority RCT." Health Technology Assessment (Winchester, England), vol. 25, no. 6, 2021, pp. 1-68.
Day AC, Burr JM, Bennett K, et al. Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT. Health Technol Assess. 2021;25(6):1-68.
Day, 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 (Winchester, England), 25(6), 1-68. https://doi.org/10.3310/hta25060
Day AC, et al. Femtosecond Laser-assisted Cataract Surgery Compared With Phacoemulsification: the FACT Non-inferiority RCT. Health Technol Assess. 2021;25(6):1-68. PubMed PMID: 33511963.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT. AU - Day,Alexander C, AU - Burr,Jennifer M, AU - Bennett,Kate, AU - Hunter,Rachael, AU - Bunce,Catey, AU - Doré,Caroline J, AU - Nanavaty,Mayank A, AU - Balaggan,Kamaljit S, AU - Wilkins,Mark R, PY - 2021/1/29/entrez PY - 2021/1/30/pubmed PY - 2021/10/26/medline KW - CORRECTED DISTANCE VISUAL ACUITY KW - FEMTOSECOND LASER-ASSISTED CATARACT SURGERY KW - INCREMENTAL COST-EFFECTIVENESS RATIO KW - LAY ADVISORY GROUP KW - LOG OF THE MINIMUM ANGLE OF RESOLUTION KW - PHACOEMULSIFICATION CATARACT SURGERY KW - QUALITY-ADJUSTED LIFE-YEAR KW - UNAIDED DISTANCE VISUAL ACUITY SP - 1 EP - 68 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 25 IS - 6 N2 - BACKGROUND: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77602616. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 6. See the NIHR Journals Library website for further project information. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used). SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/33511963/Femtosecond_laser_assisted_cataract_surgery_compared_with_phacoemulsification:_the_FACT_non_inferiority_RCT_ L2 - https://doi.org/10.3310/hta25060 DB - PRIME DP - Unbound Medicine ER -