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Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery: randomized
Alexander C Day1, Jennifer M Burr, Kate Bennett
1From the NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust (Day, Wilkins), London, Moorfields Eye Hospital (Day, Wilkins), London, UCL Institute of Ophthalmology (Day), London, School of Medicine, University of St. Andrews (Burr), St. Andrews, UCL Comprehensive Clinical Trials Unit (Bennett, Dore, Hunter), London, Department of Primary Care & Public Health Sciences, King's College London (Bunce), London, Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust (Nanavaty), Brighton, Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust (Balaggan), Wolverhampton, United Kingdom.
Purpose:
To report the 1-year outcomes of a randomized trial comparing femtosecond laser-assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS).
Setting:
Moorfields Eye Hospital, New Cross Hospital, and Sussex Eye Hospital, United Kingdom.
Design:
Multicenter, randomized controlled noninferiority trial.
Methods:
Patients undergoing cataract surgery were randomized to FLACS or PCS. Postoperative assessments were masked. Outcomes included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), complications, corneal endothelial cell count, and patient-reported outcomes measures.
Results:
The study enrolled 785 participants. A total of 311 of 392 (79%) participants were allocated to FLACS and 292 of 393 (74%) participants were allocated to PCS attended follow-up at 1 year. Mean UDVA was 0.14 (SD = 0.22) for FLACS and 0.17 (0.25) for PCS with difference of -0.03 logarithm of the minimum angle of resolution (logMAR) (95%, -0.06 to 0.01, P = .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 = .11); 75% of both FLACS (230/307) and PCS (218/290) cases were within ±0.5 diopters (D) refractive target, and 292 (95%) of 307 eyes of FLACS and 279 (96%) of 290 eyes of PCS groups were within ±1.0 D. 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 = .036) favoring FLACS. Mean cost difference was £167.62 per patient greater for FLACS (95% iterations between -£14.12 and £341.67).
Conclusions:
PCS is not inferior to FLACS regarding vision, patient-reported health, and safety outcomes after 1-year follow-up. A difference was found for binocular CDVA, which, although statistically significant, was not clinically important. FLACS was not cost-effective.
