Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT (original) (raw)
Related papers
Clinical Ophthalmology, 2021
Purpose: To assess visual outcomes over time of femtosecond laser-assisted cataract surgery compared to standard phacoemulsification cataract surgery. Design: A retrospective, single-center comparative study. Methods: Patient data including demographics, ocular biometry, pre-and postoperative visual acuity, postoperative complications, primary (uncorrected distance visual acuity over time) and secondary visual outcomes (uncorrected near visual acuity, best distance visual acuity, patient complaints, satisfaction, and postoperative surgery) were gathered and statistically analyzed. Demographic differences between patients receiving femtosecond-laser assisted cataract surgery (FLACS) versus standard phacoemulsification cataract surgery (PCS) were corrected for outcome comparison. Safety, efficacy, predictability, and stability were analyzed for each procedure and compared. Results: A total of 155 eyes in PCS and 143 eyes in FLACS were analyzed at 1 week, 3 months, and 1 year using odds ratio. The odds ratio of being 20/20 or better and 20/40 or better at the specified time periods were similar and statistically insignificant at all time periods analyzed except 20/20 or better for uncorrected distance visual acuity (UDVA) at 1 year (p=0.0001) and uncorrected near visual acuity (UNVA) at 1 week (p=0.02). In both cases, the odds of being 20/20 or better favored FLACS. Mean UDVA, UNVA, and best distance visual acuity (BDVA) were all similar and statistically insignificant between the two groups. Postoperative patient complaints, safety, efficacy, predictability, and stability between the two groups showed no statistical significance. Conclusion: Despite the odds ratio of being 20/20 or better favoring FLACS for UDVA at 1 year and UNVA at 1 week, the mean logMAR UDVA, BDVA, and UNVA were similar and statistically insignificant between the FLACS and PCS groups at 1 week, 3 months, and 1 year. Differences in visual acuity were likely due to differences other than surgical approaches. While both FLACS and PCS are appropriate approaches to cataract surgery, one does not appear to be superior when assessing longitudinal markers for visual acuity, safety, efficacy, predictability and stability.
Middle East African Journal of Ophthalmology, 2015
Purpose: We present the visual outcomes 6 weeks following Femtosecond laser assisted cataract surgery (FLACS) and conventional phacoemulsification cataract extraction (CE) cataract surgeries in 2013. Materials and Methods: This was a review of health record type of study. Eyes operated by FLACS and an equal number of conventional phacoemulsification (CE) on the same day by same surgeon were included in the study. Demographics, preoperative status, operative details and the best-corrected visual acuity (BCVA) at 6-8 weeks following surgery were noted. BCVA of >20/60 was considered as "excellent." The rate and determinants of "excellent" vision were calculated. Result: Study population comprised of 154 eyes. Both FLACS and CL groups had 77 eyes. Visual acuity at 6-8 weeks was "excellent" in 44 (60%) eyes of FLACS group and 36 (40%) eyes of CE. Visual outcome following FLACS and conventional surgery was not different (Odd's ratio [OR] 1.5 [95% confidence intervals [CI]: 0.8-2.9]). Operating surgeon did not significantly influence the visual outcomes following FLACS (OR = 1.6) and CE (OR = 0.4). Association of the grade of lens opacities to the visual outcome was not affected by type of surgery (χ 2 = 0.5, P = 0.2). The duration of surgery in CE and FLACS groups was not significantly different (−3.2 min [95% CI: −13; 6.6]). Conclusion: Visual outcomes at 6-8 weeks following CE were not different from FLACS. Visual outcomes following FLACS and CE were not influenced by the operating surgeon or severity of the cataract. The time required for FLACS was greater than that required for CE.
BMC Ophthalmology, 2020
Background To compare the visual and refractive outcomes of femtosecond laser assisted cataract surgery (FLACS) using Victus platform (Technolas Bausch and Lomb (B&L), Munich, Germany) and conventional phacoemulsification cataract surgery (CPCS). Methods A retrospective study of 100 eyes operated for cataract. FLACS was performed in 50 eyes and CPCS was done in another 50 eyes. Preoperative and 6 months postoperative visual and refractive evaluation (efficacy, safety, predictability, and surgically induced astigmatism) as well as higher-order aberrations were analyzed. Efficacy index which equals post-operative mean of uncorrected distance visual acuity (UDVA) divided by preoperative mean corrected distance visual acuity (CDVA) was calculated in both groups. Safety index equals post-operative mean of corrected distance visual acuity (CDVA) divided by preoperative mean CDVA. Results Logarithm of the Minimum Angle of Resolution (LogMAR), UDVA improved in both groups after surgery (p
Ophthalmology, 2018
Femtosecond laser-assisted cataract surgery (FLACS) has emerged as an alternative to manual cataract surgery (MCS) for corneal incision and capsulorhexis creation, as well as nuclear fragmentation. This study compares postoperative refractive and visual outcomes in eyes receiving MCS or FLACS. Single-center, comparative, retrospective cohort analysis. Consecutive eyes receiving FLACS and MCS from July 1, 2012, to July 31, 2015, at a single tertiary care center. Demographic data, ocular history, preoperative measurements and biometry, and postoperative surgical results were retrospectively obtained and statistically analyzed using a generalized linear mixed model adjusting for differences in baseline characteristics and within-patient correlation. A 2-tailed P value <0.05 was considered statistically significant throughout the study. Percentage of eyes achieving absolute error (AE) ≤0.5 diopters (D). Secondary outcomes included percentage of eyes with AE ≤0.25 D and ≤1.0 D, and pe...
BMC Ophthalmology, 2019
Background: In this analysis, we aimed to systematically compare the complications which were associated with femtosecond laser-assisted cataract surgery (FLACS) versus the conventional phacoemulsification surgery (CPE). Methods: Commonly used search databases, specifically MEDLINE, Cochrane Central, EMBASE, and http://www. clinicaltrials.gov were carefully searched for English publications comparing FLACS versus CPE. The selected endpoints which were assessed included incomplete capsulotomy, anterior capsulotomy tag, anterior capsule tear, posterior capsule tear, injury to the descemet's membrane, zonular dialysis, vitreous loss, macular or corneal edema, and elevated intra-ocular pressure. Statistical analysis was carried out by the latest version of the RevMan software (version 5.3) and represented by risk ratios (RR) with 95% confidence intervals (CI). Results: A total number of 7156 participants were included. Three thousand five hundred and fifty four (3554) participants were assigned to the FLACS group. The risks for incomplete capsulotomy, anterior capsulotomy tag, and anterior capsular tear were significantly higher with FLACS (RR: 22.
Femtosecond laser-assisted cataract surgery versus 2.2 mm clear corneal phacoemulsification
Indian Journal of Ophthalmology, 2017
Phacoemulsification is the surgical procedure of choice for cataract, providing excellent visual and safety outcomes. Femtosecond laser-assisted cataract surgery (FLACS) is an addition to the surgical armamentarium. The study aims to compare the outcomes of FLACS using LenSx ™ (Alcon Inc., USA) to standard 2.2 mm clear corneal phacoemulsification. Prospective case-control, comparative, interventional study was conducted in a tertiary care center. Methods: In each group, 55 eyes of 55 patients underwent cataract surgery using either FLACS or conventional phacoemulsification (control group). The primary outcome variables, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), specular microscopy, pachymetry, mean absolute error (MAE), and anterior chamber depth (ACD) were compared between two groups at 4 weeks postoperatively. Intraoperative effective phaco time (EPT), postoperative circularity of the rhexis, capsular overlap over the edge of the intraocular lens (IOL), and decentration of the IOL were the secondary variables which were compared. Results: No significant difference was found between the groups for UCVA, pachymetry, MAE, and ACD at 4 weeks postoperatively. The FLACS group had better BCVA (P = 0.0294). Circularity of capsulorrhexis (P = 0), circular overlap over the edge of IOL (P = 0), and centration of IOL (P = 0.002) at 4 weeks postoperatively were better in the FLACS group. EPT was lower in FLACS for similar grade of cataract (P = 0). Endothelial cell loss in FLACS group was 4.2% more (P = 0.032). Conclusions: FLACS is superior to conventional phaco in the circularity of rhexis, capsular overlap, and centration of the IOL and uses less EPT. However, conventional phacoemulsification is equivalent to FLACS in most other parameters.
Outcomes-study-between-femtosecond-laser-assisted-cataract-surgery.Clin.Ophthalmol.2017.pdf
Purpose: The purpose of this study was to compare intraoperative parameters between femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsi cation using Centurion® Vision System with Active Fluidics. Setting: This study was performed at Brasília Ophthalmologic Hospital, Brasília, Federal District, Brazil. Patients and methods: This was a prospective randomized comparative study. Patients with the diagnosis of cataract and surgical extraction programmed were divided into two groups: conventional phacoemulsi cation and FLACS. Intraoperative data were collected and submitted for statistical analysis. Results: A total of 400 eyes were enrolled, 200 in each group. There were no surgical compli- cations. Groups were statistically equivalent in age and nucleus density. Cumulative dissipated energy and torsional time were signi cantly reduced in the FLACS group. Conventional surgery had less uid usage, total case time and aspiration (ASP) time. Conclusion: FLACS with Active Fluidics System can reduce the ultrasound energy use during cataract surgery, in spite of increasing case time, uid usage and ASP time. Keywords: FLACS, ultrasound, aspiration
Femtosecond laser-assisted cataract surgery in a public teaching hospital setting
BMC ophthalmology, 2018
To evaluate the efficiency and practicality of femtosecond laser assisted cataract surgery (FLACS) in a public teaching hospital setting using a mobile FLACS system compared to conventional phacoemulsification cataract surgery (CPCS). Ninety eyes from 90 patients underwent either FLACS or CPCS (45 in each group). Cataracts were graded using the Lens Opacities Classification System III system. Outcome measures included total surgery duration, femtosecond laser treatment time, vacuum time (VT), total phacoemulsification time (TPT) and total phacoemulsification power (TPP). No differences were observed in the preoperative mean cataract grades and co-morbidities. FLACS took longer than CPCS with a mean difference of 5.2 ± 4.5 min (range: 0-18.8 min). The average femtosecond laser treatment time was 4.3 ± 3.4 min (range: 1-15.5 min). The VT was 2.51 ± 0.45 min (range: 1.59-4.10 min). Although not significant, TPT in FLACS showed a trend towards improvement (mean 1.0 ± 0.6 s; range: 0.1-2...
Medicine, 2019
The purpose of our study was to compare the selected parameters of the anterior segment of the eye in patients after femtosecond laser-assisted cataract surgery (FLACS) with the results of microincision cataract surgery (MICS) and conventional phacoemulsification surgery (CPS). This single-center prospective randomized comparative observational study included 87 patients. Patients were randomly selected into group A (FLACS), group B (MICS) and group C (control group). All the surgeries were performed by the same experienced surgeon. Preoperative and postoperative parameters were evaluated: best-corrected visual acuity (BCVA), endothelial cell density (ECD), endothelial cell loss percentage (ECL%), central corneal thickness (CCT), central anterior and posterior corneal astigmatism induction, posterior corneal elevation map were measured. Intraoperative parameters: effective phacoemulsification time (EPT), balanced salt solution use (BSS use), total surgical time and suction time were analyzed. Examination was performed preoperatively and on the first, seventh day, one and six months postoperatively. The follow up period was 6 months. There was no statistically significant difference in BCVA, central anterior and posterior astigmatism induction between studied groups. The ECL% was statistically significant lower in the group A on the 7th day, 1 month and 6-months postoperatively (P < .05). The CCT was statistically significant lower in the group A and in the group B than in the group C on the 7th postoperative day (P = .002). However, in the 6 months follow-up there was no statistically significant difference in the CCT between studied groups (P = .133). We observed statistically significant difference in change of the posterior corneal elevation map at the periphery assessed within the 90°to 120°meridian range between group A, group B and group C at every timepoint postoperatively (P < .05). The EPT and BSS use were statistically significant lower whilst total surgery time was statistically significant higher in the FLACS group (P < .05). To conclude in the 6 months follow-up there was statistically significant difference found between eyes undergoing FLACS, MICS and CPS with respect to the posterior corneal elevation map assessed within the studied range, ECL%, EPT, BSS use and total surgery time. Postoperative BCVA, central anterior and posterior astigmatism induction, CCT were comparable between studied groups. Abbreviations: BCVA = best-corrected visual acuity, BSS use = balanced salt solution use, CCT = central corneal thickness, CPS = conventional phacoemulsification surgery, ECD = endothelial cell density, ECL% = endothelial cell loss percentage, EPT = effective phacoemulsification time, FDA = Food and Drug Administration, FLACS = femtosecond laser-assisted cataract surgery, IOL = intraocular lens, LCS = laser cataract surgery, LOCS = Lens Opacities Classification System, MICS = microincision cataract surgery, NC = nuclear color, NO = nuclear opacity, OVD = ophthalmic viscosurgical device, RCTs = randomized controlled trials, SD = standard deviation; MD = mean difference, SICS = small incision cataract surgery.
Eye and Vision
Background: To compare femtosecond laser-assisted versus conventional phacoemulsification in terms of visual and refractive outcomes, cumulative dissipated energy, anterior chamber inflammation and endothelial cell loss. Methods: In this retrospective cohort study, records of eyes that underwent femtosecond laser-assisted cataract surgery (FLACS) or conventional phacoemulsification (CP) were reviewed. The Victus femtosecond laser (Bausch and Lomb, Germany) was used to carry out corneal incisions, anterior capsulotomy, and lens fragmentation in FLACS procedures. Manifest refraction spherical equivalence (MRSE), uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), cumulative dissipated energy (CDE), postoperative cells and flare and endothelial cell count data were collected. Subgroup analysis of the visual acuity tests was performed based on the type of intraocular lens implanted (monofocal, monofocal toric, multifocal, multifocal toric, accommodating). Results: A total of 735 eyes were included in the study (296 eyes for the FLACS group and 439 eyes for the CP group). At one year follow-up, 120 eyes comprised the FLACS group and 265 eyes for the CP group. MRSE in the FLACS group was − 0.16 ± 0.58 D and − 0.20 ± 0.52 D in the CP group (P = 0.50). UDVA in the FLACS group was 20/25 (mean logMAR 0.12 ± 0.13) and 20/25 (mean logMAR 0.11 ± 0.13) in the CP group (P = 0.48). CDVA was 20/20 (mean logMAR 0.03 ± 0.07) in the FLACS group and 20/20 (mean logMAR 0.02 ± 0.06) in the CP group (P = 0.15). No statistically significant trend was seen for FLACS versus CP by intraocular type for visual acuity. CDE for the different cataract grades ranged from 6.97 ± 5.74 to 29.02 ± 16.07 in the FLACS group and 7.59 ± 6.42 to 35.69 ± 18.30 in the CP group. The FLACS group was significantly lower for post-operative central corneal edema (P = 0.05), cells and flare (P = 0.01), and endothelial cell loss (P = 0.04). Conclusions: Femtosecond laser-assisted cataract surgery and conventional phacoemulsification had similar refractive and visual outcomes. Phacoemulsification energy, anterior chamber inflammation and corneal endothelial cell loss were less in the femtosecond laser group.