Femtosecond laser-assisted cataract surgery compared with phacoemulsification : the FACT non-inferiority RCT
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).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:25 |
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| Enthalten in: |
Health technology assessment (Winchester, England) - 25(2021), 6 vom: 29. Jan., Seite 1-68 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Day, Alexander C [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 25.10.2021 Date Revised 25.10.2021 published: Print ISRCTN: ISRCTN77602616 Citation Status MEDLINE |
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| doi: |
10.3310/hta25060 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM32073479X |
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| 041 | |a eng | ||
| 100 | 1 | |a Day, Alexander C |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Femtosecond laser-assisted cataract surgery compared with phacoemulsification |b the FACT non-inferiority RCT |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 25.10.2021 | ||
| 500 | |a Date Revised 25.10.2021 | ||
| 500 | |a published: Print | ||
| 500 | |a ISRCTN: ISRCTN77602616 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a OBJECTIVES: To compare FLACS with phacoemulsification cataract surgery (PCS) | ||
| 520 | |a DESIGN: Multicentre, outcome-masked, randomised controlled non-inferiority trial | ||
| 520 | |a SETTING: Three collaborating NHS hospitals | ||
| 520 | |a PARTICIPANTS: A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017 | ||
| 520 | |a INTERVENTION: FLACS (n = 392 participants) or PCS (n = 393 participants) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a LIMITATIONS: Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked | ||
| 520 | |a 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 | ||
| 520 | |a FUTURE WORK: To explore the possible differences in vision in patients without ocular co-pathology | ||
| 520 | |a TRIAL REGISTRATION: Current Controlled Trials ISRCTN77602616 | ||
| 520 | |a 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) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a CORRECTED DISTANCE VISUAL ACUITY | |
| 650 | 4 | |a FEMTOSECOND LASER-ASSISTED CATARACT SURGERY | |
| 650 | 4 | |a INCREMENTAL COST-EFFECTIVENESS RATIO | |
| 650 | 4 | |a LAY ADVISORY GROUP | |
| 650 | 4 | |a LOG OF THE MINIMUM ANGLE OF RESOLUTION | |
| 650 | 4 | |a PHACOEMULSIFICATION CATARACT SURGERY | |
| 650 | 4 | |a QUALITY-ADJUSTED LIFE-YEAR | |
| 650 | 4 | |a UNAIDED DISTANCE VISUAL ACUITY | |
| 700 | 1 | |a Burr, Jennifer M |e verfasserin |4 aut | |
| 700 | 1 | |a Bennett, Kate |e verfasserin |4 aut | |
| 700 | 1 | |a Hunter, Rachael |e verfasserin |4 aut | |
| 700 | 1 | |a Bunce, Catey |e verfasserin |4 aut | |
| 700 | 1 | |a Doré, Caroline J |e verfasserin |4 aut | |
| 700 | 1 | |a Nanavaty, Mayank A |e verfasserin |4 aut | |
| 700 | 1 | |a Balaggan, Kamaljit S |e verfasserin |4 aut | |
| 700 | 1 | |a Wilkins, Mark R |e verfasserin |4 aut | |
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