scholarly journals Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT

2021 ◽  
Vol 25 (6) ◽  
pp. 1-68
Author(s):  
Alexander C Day ◽  
Jennifer M Burr ◽  
Kate Bennett ◽  
Rachael Hunter ◽  
Catey Bunce ◽  
...  

Background Cataract surgery is one of the most common operations. Femtosecond laser-assisted cataract surgery (FLACS) is a technique that automates a number of operative steps. Objectives To compare FLACS with phacoemulsification cataract surgery (PCS). Design Multicentre, outcome-masked, randomised controlled non-inferiority trial. Setting Three collaborating NHS hospitals. Participants A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017. Intervention FLACS (n = 392 participants) or PCS (n = 393 participants). Main outcome measures The primary outcome was uncorrected distance visual acuity in the study eye after 3 months, expressed as the logarithm of the minimum angle of resolution (logMAR): 0.00 logMAR (or 6/6 if expressed in Snellen) is normal (good visual acuity). Secondary outcomes included corrected distance visual acuity, refractive outcomes (within 0.5 dioptre and 1.0 dioptre of target), safety and patient-reported outcome measures at 3 and 12 months, and resource use. All trial follow-ups were performed by optometrists who were masked to the trial intervention. Results A total of 353 (90%) participants allocated to the FLACS arm and 317 (81%) participants allocated to the PCS arm attended follow-up at 3 months. The mean uncorrected distance visual acuity was similar in both treatment arms [0.13 logMAR, standard deviation 0.23 logMAR, for FLACS, vs. 0.14 logMAR, standard deviation 0.27 logMAR, for PCS, with a difference of –0.01 logMAR (95% confidence interval –0.05 to 0.03 logMAR; p = 0.63)]. The mean corrected distance visual acuity values were again similar in both treatment arms (–0.01 logMAR, standard deviation 0.19 logMAR FLACS vs. 0.01 logMAR, standard deviation 0.21 logMAR PCS; p = 0.34). There were two posterior capsule tears in the PCS arm. There were no significant differences between the treatment arms for any secondary outcome at 3 months. At 12 months, the mean uncorrected distance visual acuity was 0.14 logMAR (standard deviation 0.22 logMAR) for FLACS and 0.17 logMAR (standard deviation 0.25 logMAR) for PCS, with a difference between the treatment arms of –0.03 logMAR (95% confidence interval –0.06 to 0.01 logMAR; p = 0.17). The mean corrected distance visual acuity was 0.003 logMAR (standard deviation 0.18 logMAR) for FLACS and 0.03 logMAR (standard deviation 0.23 logMAR) for PCS, with a difference of –0.03 logMAR (95% confidence interval –0.06 to 0.01 logMAR; p = 0.11). There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of –0.02 logMAR (95% confidence interval –0.05 to 0.00 logMAR) (p = 0.036), which favoured FLACS. There were no significant differences between the arms for any health, social care or societal costs. For the economic evaluation, the mean cost difference was £167.62 per patient higher for FLACS (95% of iterations between –£14.12 and £341.67) than for PCS. The mean QALY difference (FLACS minus PCS) was 0.001 (95% of iterations between –0.011 and 0.015), which equates to an incremental cost-effectiveness ratio (cost difference divided by QALY difference) of £167,620. Limitations Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked. Conclusions The evidence suggests that FLACS is not inferior to PCS in terms of vision after 3 months’ follow-up, and there were no significant differences in patient-reported health and safety outcomes after 12 months’ follow-up. In addition, the statistically significant difference in binocular corrected distance visual acuity was not clinically significant. FLACS is not cost-effective. Future work To explore the possible differences in vision in patients without ocular co-pathology. Trial registration Current Controlled Trials ISRCTN77602616. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 6. See the NIHR Journals Library website for further project information. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used).

2018 ◽  
Vol 30 (1) ◽  
pp. 139-146 ◽  
Author(s):  
Guilherme Andrade do Nascimento Rocha ◽  
Paulo Ferrara de Almeida Cunha ◽  
Leonardo Torquetti Costa ◽  
Luciene Barbosa de Sousa

Importance: This study shows that a newer long-arc length intrastromal corneal ring segment is efficient and safe for keratoconus treatment. Background: To evaluate visual, tomographic results and complications of a 320-degree intrastromal corneal ring segment implantation with the femtosecond laser for keratoconus treatment. Design: A prospective, nonrandomized, and interventional study. Participants: A total of 34 eyes of 31 patients diagnosed with keratoconus were enrolled. Methods: Patients were divided into two groups based on the strategy used for 320-degree intrastromal corneal ring segment thickness selection. In one group, this selection was based on spherical equivalent (SE group) and in the other on the mean asphericity (Q group). The uncorrected and corrected distance visual acuities, spherical equivalent, K1, K2, Km, Kmax, and mean asphericity ( Q) on corneal tomography were evaluated preoperatively and at 3 and 6 months postoperatively. For astigmatism improvement, we analyzed the corneal tomographic vectorial astigmatism change preoperatively and at 6 months postoperatively. The mean follow-up period was 6.63 ± 0.96 months. Results: The mean uncorrected distance visual acuity and corrected distance visual acuity improved with a significant spherical equivalent improvement ( p < 0.05), with no differences between the 320-degree intrastromal corneal ring segment groups. All corneal tomographic parameters improved significantly ( p < 0.05) between the preoperative and postoperative intervals, with a significant better performance when we used spherical equivalent for the 320-degree intrastromal corneal ring segment thickness selection. Finally, the mean vectorial corneal tomographic astigmatism significantly improved after 6 months, again with no differences between groups. Conclusion: This study suggests that implanting a 320-degree intrastromal corneal ring segment is a safe and effective procedure for treating patients with keratoconus. It also suggests that for thickness selection spherical equivalent is the better strategy.


2019 ◽  
Vol 4 (1) ◽  
pp. e000233 ◽  
Author(s):  
Therese Krarup ◽  
Rasmus Ejstrup ◽  
Anouck Mortensen ◽  
Morten la Cour ◽  
Lars Morten Holm

ObjectiveFemtosecond laser-assisted cataract surgery (FLACS) decreases the use of energy and provides a more precise capsulorhexis compared with conventional phaco surgery (CPS). The purpose of this study was to examine if the lower energy use in FLACS caused less endothelial cell loss compared with CPS and if there was a difference in refractive predictability between CPS and FLACS.Methods and analysisThis was a randomised controlled study of 96 patients with a 6-month follow-up comparing one eye surgery by FLACS and the contralateral eye operated by CPS (divide and conquer technique). Both eyes had intraocular aspheric lenses implanted. Uncorrected distance visual acuity, corrected distance visual acuity (CDVA), central corneal endothelial cell count and hexagonality (non-contact endothelial cell microscope) were assessed preoperatively at 40 and at 180 days postoperatively.ResultsThe mean phaco energies were 6.55 (95% CI 5.43 to 7.66) and 9.77 (95% CI 8.55 to 10.95) U/S (p<0.0001) by FLACS and CPS, respectively. At day 40, the mean endothelial cell loss (ECL) was 344 cells/mm2 (95% CI 245 to 443) by FLACS (12.89%) and 497 cells/mm2 (95% CI 380 to 614) by CPS (18.19%) (p=0.027). At day 180, ECL was 362 cells/mm2 (95% CI 275 to 450) in FLACS (13.56%) and 465 cells/mm2 (95% CI 377 to 554) in CPS (17.03%) (p=0.036).The mean absolute difference from the attempted refraction was 0.43 (95% CI 0.36 to 0.51) dioptres (D) at day 40 and 0.46 D (95% CI 0.39 to 0.53) at day 180 by FLACS compared with 0.43 D (95% CI 0.36 to 0.51) at day 40 (p=0.95) and 0.46 D (95% CI 0.37 to 0.52) at day 180 (p=0.91) with CPS.ConclusionECL was significantly lower in FLACS compared with CPS at both day 40 and day 180. ECL was correlated to the energy used. We found no difference in refractive predictability or CDVA between the groups.


2020 ◽  
pp. 112067212090356
Author(s):  
Eliya Levinger ◽  
Michael Mimouni ◽  
Yaron Finkelman ◽  
Yossi Yatziv ◽  
Jonathan Shahar ◽  
...  

Purpose: The purpose of this study was to assess the results of a sulcus intraocular lens (Sulcoflex) for pseudophakic refractive errors following phacoemulsification cataract surgery. Methods: This retrospective clinical observational cohort study included consecutive eyes in which a Sulcoflex was implanted. Uncorrected distance visual acuity and corrected distance visual acuity as well as refractive outcomes were assessed. The minimum follow-up time required for inclusion was 3 months. Results: In total, 15 eyes ( n = 15) were evaluated. The mean follow-up was 14 months (range: 3–18 months). The Sulcoflex aspheric (653L) was implanted in 13 eyes and the Sulcoflex toric (653T) in two eyes. The preoperative mean logMAR (Snellen) uncorrected distance visual acuity and corrected distance visual acuity were 0.88 (20/150) and 0.27 (20/40), respectively. The postoperative mean logMAR (Snellen) corrected distance visual acuity was 0.15 (20/30). The preoperative mean spherical equivalent was −0.22 ± 5.95 D and the postoperative mean spherical equivalent was −1.59 ± 1.45 D. There was a significant and strong correlation ( r = 0.64, p < 0.001) between the attempted and the achieved spherical equivalent. Conclusion: The Sulcoflex is a safe and viable option for patients with residual refractive error following cataract surgery.


2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Ercüment Bozkurt ◽  
Engin Bilge Ozgurhan ◽  
Betul Ilkay Sezgin Akcay ◽  
Tugba Kurt ◽  
Yusuf Yildirim ◽  
...  

Purpose. To report the visual, refractive, and corneal topography and wavefront aberration results of accelerated corneal cross-linking (CXL) during a 24-month follow-up.Methods. Forty-seven eyes underwent riboflavin-ultraviolet A-induced accelerated CXL treatment (30 mW/cm2with a total dose of 7.2 joules/cm2). Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical and cylindrical values, keratometry (K) measurements (Ksteep,Kflat,Kavg, andKapex), central corneal thickness, and anterior corneal aberrometric analyses including total wavefront error (WFE), total high order aberration (HOA), astigmatism, trefoil, coma, quadrafoil, secondary astigmatism, and spherical aberration were evaluated.Results. The mean UDVA and CDVA were significantly improved at 1 (p=0.003andp=0.004, resp.) and 2 years after treatment (p=0.001andp=0.001, resp.). The meanKsteep,Kflat,Kaverage, andKapexvalues were significantly lower than baseline at 12 months (p=0.008,p=0.024,p=0.001, andp=0.014, resp.) and 24 months (p=0.014,p=0.017,p=0.001, andp=0.012, resp.). Corneal thickness showed a significant decrease at 1 month. Total HOA and coma decreased significantly at the 12-month (p=0.001andp=0.009, resp.) and 24-month visits (p=0.001andp=0.007, resp.).Conclusion. Accelerated CXL (30 mW/cm2) was found to be effective in improving UDVA, CDVA, corneal topography readings, total HOA, and coma aberrations during the 24-month follow-up.


2018 ◽  
Vol 30 (1) ◽  
pp. 125-131
Author(s):  
Cristina Peris-Martínez ◽  
Inmaculada Bueno-Gimeno ◽  
Izaskun Alvarez-Arana ◽  
David P Piñero ◽  
Andrés Gené-Sampedro

Purpose: To evaluate the visual, refractive, topographic, pachymetric, and biomechanical outcomes after intracorneal ring segment implantation in corneas with post-LASIK ectasia. Methods: Retrospective longitudinal study enrolling 26 eyes of 22 patients with post-LASIK ectasia and undergoing intracorneal ring segment implantation (KeraRing®, Mediphacos) using a 60-kHz femtosecond laser (IntraLase®, IntraLase Corp.) for corneal tunnelization. Visual, refractive, anterior, and posterior corneal topographic (Pentacam HR, Oculus), pachymetric, and corneal biomechanical changes (Ocular response Analyzer, Reichert) were evaluated during a 12-month follow-up. Vector analysis of astigmatic changes was performed. Results: A statistically significant reduction of sphere (p = 0.043) was observed at 1 month after surgery, with a significant improvement of uncorrected distance visual acuity associated (p = 0.019). Likewise, a significant reduction of anterior corneal power measurements (p ⩽ 0.014) and steepest posterior keratometric reading (p = 0.006) were observed at 1 month postoperatively, with no significant changes afterwards (p ⩾ 0.133). No significant changes were observed in manifest cylinder (p ⩾ 0.175), corrected distance visual acuity (p ⩾ 0.174), flattest posterior keratometric measurement (p ⩾ 0.282), volumetric measurements (p ⩾ 0.051), and corneal biomechanical parameters (p ⩾ 0.068). Vector analysis revealed an initial trend to overcorrection of astigmatism, with a trend to undercorrection at the end of follow-up and a significant variability in the outcome achieved in each patient. Conclusion: The implantation of KeraRing segments in post-LASIK corneal ectasia generates a significant modification of spherical refraction and a visual improvement due to a central corneal flattening generated. More refined nomograms of implantation in these cases should be developed to achieve a more predictable correction of astigmatism.


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Takashi Kojima ◽  
Yoshihiro Kitazawa ◽  
Tomoaki Nakamura ◽  
Masahide Takahashi ◽  
Kazutaka Kamiya ◽  
...  

Purpose. To compare the visual and refractive outcomes and night vision performance questionnaire results between V4c and V5 implantable Collamer lenses in a prospective, randomized, multicenter study.Settings. Four refractive surgery centers.Design. Prospective randomized multicenter single-masked comparative study.Methods. Twenty-three patients were enrolled in this study. A conventional V4c model (EVO Visian ICL) was implanted in one eye, and a V5 model (EVO+ Visian ICL), which has a larger optic diameter than the V4c model, was implanted in the contralateral eye. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were evaluated before and 6 months after surgery. At 6 months after surgery, a questionnaire on night vision disturbances was administered. The efficacy, safety, and predictability of the two implanted ICL models were compared.Results. There were no significant differences in the postoperative UDVA and CDVA between the two ICL models. The mean efficacy indexes for the V4c and V5 lenses were 1.16 ± 0.22 and 1.03 ± 0.23, respectively. The mean safety indexes of the V4c and V5 lenses were 1.21 ± 0.20 and 1.19 ± 0.20, respectively. The night vision performance questionnaire revealed that 7 patients (37%) noticed a difference in visual performance between the eyes, and all of them reported that they could see better at night with the V5-implanted eye compared with the V4c-implanted eye.Conclusion. The V4c and V5 ICL models achieved similar visual and refractive outcomes, whereas the V5 model showed a possible advantage in reducing night vision disturbances.


2017 ◽  
Vol 28 (1) ◽  
pp. 103-107 ◽  
Author(s):  
Yehia S. Mostafa ◽  
Amr A. Osman ◽  
Dina H. Hassanein ◽  
Ashraf M. Zeid ◽  
Ahmed M. Sherif

Purpose: To discuss the limitations and benefits of the BrightOcular prosthetic artificial iris device in management of aniridia associated with aphakia or cataract. Methods: This is a retrospective study including 5 eyes of 4 patients who underwent implantation of the BrightOcular iris prosthesis (Stellar Devices) for total or partial aniridia. The cases included 2 eyes of 1 patient with congenital aniridia associated with congenital cataract and 3 eyes with traumatic aniridia: 1 with subluxated cataractous lens and 2 with aphakia. In all cases, the iris prosthesis was implanted after a 3-piece acrylic intraocular lens was implanted. We evaluated the clinical course with a minimum follow-up period of 6 months, the intraoperative and postoperative complications, and the cosmetic satisfaction of patients. Results: All patients had improved uncorrected distance visual acuity and best-corrected distance visual acuity. All patients had a transient corneal edema that resolved within the first postoperative week. Only the patient with congenital aniridia had a permanent increase in intraocular pressure and developed a band keratopathy throughout a 2-year follow-up period. The prosthesis was well-centered in all eyes except for one case that required scleral suture fixation after 3 months. All patients had a satisfactory cosmetic appearance. Conclusions: BrightOcular iris prosthesis is a safe and useful tool to correct aniridia associated with pseudophakia or aphakia. Being foldable, it is easy to be implanted through a small incision and placed in the ciliary sulcus without sutures when properly sized. Cosmetic results are satisfactory. Sizing methods should be improved.


Author(s):  
Isaak R. Fischinger ◽  
Jascha Wendelstein ◽  
Kristin Tetz ◽  
Matthias Bolz ◽  
Manfred R. Tetz

Abstract Purpose To evaluate the influence of the type of the keratectasia and preoperative keratometry readings on the efficacy of implantation of iris-fixated phakic anterior chamber intraocular lenses (pIOL) in patients with keratoconus. Methods In this retrospective study, iris-fixated pIOLs (Artisan/Artiflex (Ophtec®), Verisyse/Veriflex (AMO®)) were implanted in 38 eyes of 22 patients with stable keratoconus. Thirty-six eyes underwent corneal crosslinking (CXL) prior to the lens implantation. The refractive outcome was evaluated 6 weeks postoperatively and the influence of preoperative refraction and topo- and tomographical factors were analyzed. Results The mean postoperative uncorrected distance visual acuity (UDVApost) was 0.25 ± 0.15 logMAR and was not statistically different from the mean preoperative corrected distance visual acuity (CDVApre), which was 0.24 ± 0.13 logMAR. Twenty-seven eyes (71%) reached UDVApost/CDVApre ≥ 1 (efficacy index), whereas patients with PMD-like ectasia (n = 14) showed significantly (p = 0.003) higher efficacy index (100%) than patients diagnosed with keratoconus (n = 24) (54%). Higher eccentricity of the maximum posterior elevation showed a significant beneficial influence on the efficacy index (p = 0.021). Furthermore, a higher Amsler-Krumeich stage and preoperative MAE were correlated with a worse UDVApost. The mean absolute spherical equivalent was significantly decreased from 5.71 ± 4.96 D to 1.25 ± 1.20 D (p < 0.001). No significant difference was found in endothelial cell count. Conclusion The results indicate that the implantation of phakic iris-fixated anterior chamber IOLs is a reasonable refractive option for patients with keratoconus. Keratoconus patients with a pellucidal marginal degeneration (PMD)-like appearance ectasia seem to benefit most from such procedures.


2020 ◽  
pp. bjophthalmol-2019-314548
Author(s):  
Daliya Dzhaber ◽  
Osama M Mustafa ◽  
Fares Alsaleh ◽  
Yassine J Daoud

Background/aimTo compare visual and refractive outcomes, changes in intraocular pressure (IOP), and complications of femtosecond laser-assisted cataract surgery (FLACS) to conventional phacoemulsification surgery (CPS) in paired eyes from the same patients.MethodsThis is a secondary analysis of an intraindividual, randomised, controlled clinical trial including 110 paired eyes from 55 patients that were randomised into either FLACS or CPS groups. Outcomes were recorded at baseline and postoperatively during a 3-month follow-up period.ResultsUncorrected distance visual acuity and corrected distance visual acuity were similar between FLACS and CPS over the follow-up period (p>0.05). The mean absolute refractive error was not significantly different between the two groups at postoperative month 1 (POM1) (0.3±0.2 D in FLACS vs 0.4±0.3 D in CPS, p=0.18) and month 3 (POM3) (0.3±0.3 D in FLACS vs 0.3±0.3 D in CPS, p=0.71). IOP was statistically higher in the FLACS group on postoperative day 1 (20.6±5.7 mm Hg for FLACS and 18.0±4.9 mm Hg for CPS, p=0.01). However, it was similar between the two groups subsequently (p>0.05). Intraoperatively, one case of posterior capsular block syndrome was observed in the FLACS group. Postoperatively, one case of newly developed glaucoma was observed in the FLACS group and one case of retinal tears in the CPS group.ConclusionThe 3-month postoperative refractive and visual outcomes were comparable between FLACS and CPS in paired eyes from the same patients. Complication rate was low in the study population.


2019 ◽  
Vol 30 (4) ◽  
pp. 643-649 ◽  
Author(s):  
Luis Fernández-Vega-Cueto ◽  
Carlos Lisa ◽  
Aranzazu Poo-López ◽  
José F Alfonso ◽  
David Madrid-Costa

Purpose: To assess the outcomes of implanting Ferrara-type intrastromal corneal ring segments in central ‘bow-tie’-shaped keratoconus over 3 years of follow-up. Methods: A total of 20 eyes with central ‘bow-tie’-shaped keratoconus were evaluated before and after implanting Ferrara-type intrastromal corneal ring segments (AJL Ophthalmic, Spain). LogMAR uncorrected distance visual acuity and best corrected distance visual acuity and residual refractive errors analysed using vector analysis were recorded preoperatively, at 6 months, 1 year, and 3 years postoperatively. Results: The mean uncorrected distance visual acuity (LogMAR scale) rose from a preoperative 0.75 ± 0.28 to a 6-month postoperative 0.38 ± 0.28 (p < 0.0001). The corrected distance visual acuity, in turn, improved from 0.07 ± 0.06 to 0.05 ± 0.06 (p = 0.0008). Both the uncorrected distance visual acuity and corrected distance visual acuity were stable over the postoperative period in both groups (p > 0.05). None of the eyes lost uncorrected distance visual acuity and corrected distance visual acuity lines over the postoperative follow-up period. The spherical equivalent and the refractive cylinder declined steeply after intrastromal corneal ring segments implantation (p < 0.0001). Both the spherical equivalent and refractive cylinder were stable over the postoperative period. None of the eyes had an increase in maximum or minimum keratometry greater than 0.75D over the postoperative period. Conclusion: The planning for intrastromal corneal ring segments insertion proposed in this study reduces the spherical equivalent and refractive cylinder in this type of keratoconus, while improving post-surgery uncorrected distance visual acuity and corrected distance visual acuity. These results remain stable over 3 years of follow-up. Therefore, this procedure could be considered as an effective therapeutic alternative in patients affected by this type of keratoconus.


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