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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.
RESUMO
PURPOSE: To evaluate the differences in efficacy, predictability, safety, and visual quality between topography-guided customized ablation treatment (TCAT) and wavefront-optimized (WFO) laser in situ keratomileusis (LASIK) for the treatment of myopia with and without astigmatism. METHODS: A comprehensive literature search of PubMed, Embase, the Cochrane library, Web of Science, and ClinicalTrials was used to identify randomized controlled trials (RCTs) comparing TCAT-LASIK with WFO-LASIK for myopia with and without astigmatism up to September 2020. The references of all searched literature were checked as supplements. Literature was screened according to the inclusion and exclusion criteria and relative data were extracted. RevMan software version 5.3.0 (Cochrane Collaboration) was used for meta-analysis. RESULTS: A total of seven RCTs (1,168 eyes) were included. There were no statistically significant differences in the ratio of uncorrected distance visual acuity of 20/20 or better (relative risk [RR] = 1.01, 95% CI [0.97 to 1.06], P = .64) and 20/16 or better (RR = 0.96, 95% CI [0.80 to 1.16], P = .69). Compared with WFO-LASIK, TCAT-LASIK achieved a higher proportion of postoperative manifest refractive spherical equivalent within ±0.50 diopters of the target (RR = 1.06, 95% CI [1.02 to 1.11], P = .003) and less surgically induced higher order aberrations (weighted mean difference [WMD] = -0.11, 95% CI [-0.15 to -0.0], P < .00001), spherical aberrations (WMD = -0.04, 95% CI [-0.05 to -0.03], P < .00001), and coma (WMD = -0.15, 95% CI [-0.28 to -0.01], P = .03). No patient lost two or more lines of distance-corrected visual acuity postoperatively in the two groups. CONCLUSIONS: This meta-analysis suggests that both TCATLASIK and WFO-LASIK show excellent efficacy, predictability, and safety for myopia. TCAT-LASIK exhibited more accurate postoperative refraction predictability and less surgically induced higher order aberrations, spherical aberrations, and coma. More randomized, prospective, and large sample-sized studies are needed to confirm these conclusions in the long term. [J Refract Surg. 2021;37(10):707-714.].