Dataset Information

Comparison of Femtosecond Laser-Assisted Cataract Surgery and Conventional Phacoemulsification on Endothelial Cell Density When Using Torsional Modality

ABSTRACT:

Purpose

To compare the effects of femtosecond laser assisted cataract surgery (FLACS) and manual phacoemulsification on cumulative dissipated energy (CDE), torsional amplitude, and endothelial cell density (ECD).

Patients and Methods

This prospective, randomized study was conducted at Oka Eye Clinic (Fukuoka, Japan). Surgeries were performed using FLACS (with LenSx) or conventional technique in adults ≥20 years with grade 2–4 cataracts. Visits included preoperative, surgery day, and 5 postoperative visits (days 1, 4–10, 20–40, 60–120, and 150–210). Primary endpoint was CDE. Secondary endpoints included ECD percent change at day 150–210 versus preoperative visit and average torsional amplitude on surgery day. Exploratory endpoints included central corneal thickness and corrected distance visual acuity (CDVA). Superiority of FLACS to conventional technique was evaluated using t-tests based on a mixed model for repeated measures.

Results

Full analysis set included 53 eyes per group. Mean cataract grade was 2.92±0.58 in FLACS and 2.94±0.57 in conventional group. FLACS versus conventional method had significantly lower mean CDE (0.213±0.334 versus 1.718±0.898%-seconds, respectively; P<0.0001), demonstrating superiority of FLACS. Low endothelial cell loss (ECL) was achieved with both FLACS and conventional methods (1.5±5.6% and 2.7±5.2%; P=0.260). Torsional amplitude was significantly lower for FLACS versus conventional method (19.6±16.0% versus 31.1±6.6%; P<0.0001). Central corneal thickness was comparable for both methods at all visits except day 1; CDVA was comparable for both methods at all postoperative visits.

Conclusion

FLACS achieved significantly lower CDE compared with the conventional surgical method (P<0.0001). Low ECL was achieved with both FLACS (1.5%) and conventional (2.7%) methods. Video Abstract Point your SmartPhone at the code above. If you have a QR code reader the video abstract will appear. Or use: https://youtu.be/xzalrupRtlw

SUBMITTER: Oka Y

PROVIDER: S-EPMC8542738 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:PURPOSE:To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS). DESIGN:Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/). PARTICIPANTS:Seven hundred eighty-five patients with age-related cataract. METHODS:This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616. MAIN OUTCOME MEASURES:We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome. CONCLUSIONS:Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.

Project description:Purpose: To compare 1-year clinical outcomes, phacoemulsification energy, aqueous profiles, and patient-reported outcomes of low-energy femtosecond laser-assisted cataract surgery (FLACS) vs. conventional phacoemulsification. Methods: The study is a randomized controlled trial (RCT) with paired-eye design. Eighty-five patients were randomized to receive FLACS (Ziemer LDV Z8) in one eye and conventional phacoemulsification in the fellow eye. Clinical data including phacoemulsification energy parameters (cumulative dissipated energy, phacoemulsification power, and phacoemulsification time), uncorrected and corrected distance visual acuities (UCDVA and BCDVA), manifest refraction spherical equivalent (MRSE), central corneal thickness (CCT), endothelial cell count (ECC), anterior chamber flare, and post-operative complications were obtained for 1 year. Aqueous humor was collected for the analysis of prostaglandin (PGE)2, cytokines and chemokines concentrations. Patients' reported-outcomes on surgical experiences were evaluated using an in-house questionnaire. Results: Compared to conventional phacoemulsification, the low-energy assisted FLACS group had significantly less ECC reduction at 3 months (1.5 ± 0.3% vs. 7.0 ± 2.4%; P < 0.01) and 1 year (8.2 ± 2.8% vs. 11.2 ± 3.6%; P = 0.03). There were no significant differences in the phacoemulsification energy parameters, UCDVA, BCDVA, MRSE, CCT, occurrence of post-operative complications between the 2 groups throughout post-operative 1 year. Patients' subjective surgical experiences, including the surgical duration and perceived inconvenience, were comparable between the 2 groups. FLACS resulted in significantly higher aqueous PGE2 (P < 0.01), interleukin (IL)-6 (P = 0.03), IL-8 (P = 0.03), and interferon (IFN)-γ (P = 0.04) concentrations and greater anterior chamber flare at 1 day (P = 0.02). Conclusions: Our RCT presented 1-year longitudinal clinical and laboratory data. The long-term ECC result was more favorable in low-energy FLACS. The rest of the intraoperative and post-operative outcomes, as well as patient-reported outcomes, were comparable between these two procedures.

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