Safety and efficacy of cataract surgery performed with a low-energy femtosecond laser compared with conventional phacoemulsification in Chinese patients: a randomized clinical trial.

BACKGROUND: To compare the safety and efficacy of femtosecond laser-assisted cataract surgery (FLACS) performed with the low-energy FEMTO LDV Z8 (Ziemer Ophthalmic Systems AG, Port, Switzerland) laser compared with conventional phacoemulsification (CP) in Chinese patients. METHODS: This prospective, multicenter, interventional study included 126 patients who were randomized (1:1) to undergo either FLACS or CP followed by intraocular lens (IOL) implantation between January 2019 and April 2020. The primary endpoint included the comparison of the endothelial cell loss (ECL) between the two groups at 3 months. Secondary endpoints included the comparison of cumulative dissipated energy (CDE), change in central corneal thickness (CCT) from baseline, and postoperative uncorrected and corrected distance visual acuities (UDVA and CDVA) in the two groups. RESULTS: At all postoperative time points, the FLACS group was found to be non-inferior to CP for the mean ECL (- 409.3 versus - 436.9 cells/mm2 at 3 months) and mean CDE (4.1 versus 4.5 percent-seconds). The increase in CCT was significantly lower in the FLACS group compared with the CP group at Day 7 (4.9 versus 9.2 µm; P = 0.04); however, the difference was not statistically significant at 1 and 3 months. Postoperatively, mean UDVA and CDVA were comparable between the two groups. No intraoperative complications occurred. CONCLUSIONS: Cataract surgery performed with a low-energy femtosecond laser was non-inferior to CP; however, the FLACS group had a statistically significantly lower increase in CCT at Day 7 compared with CP. Trial registration This trial is registered at ClinicalTrials.gov on May 15, 2019, with trial registration number: NCT03953053.