Femtosecond lasers for laser in situ keratomileusis: a systematic review and meta-analysis
Abstract
Purpose: The aim of this study was to review and meta-analyze whether there are differences between reported femtosecond (FS) lasers for laser-assisted in situ keratomileusis (LASIK) in terms of efficacy, predictability, and safety as primary outcomes and corneal flap thickness measurements and pre- and postoperative complications as secondary outcomes. Methods: A comprehensive literature search of PubMed, Science Direct, Scopus, and Cochrane CENTRAL Trials Library databases was conducted to identify the relevant prospective randomized controlled trials of FS lasers for LASIK. Thirty-one articles describing a total of 5,404 eyes were included. Results: Based on efficacy, IntraLase FS 10 and 30 kHz gave the best results. Based on predictability and safety, there were no differences between various FS lasers. FEMTO LDV and IntraLase FS 60 kHz produced the most accurate flap thicknesses. IntraLase and Wavelight SF200 had the fewest intraoperative complications. IntraLase, Visumax, and Wavelight FS200 had the most seldom postoperative complications. Conclusion: There were dissimilarities between different FS lasers based on efficacy and intraoperative and postoperative complications. All FS lasers were predictable and safe for making corneal flaps in LASIK.
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Clinical Ophthalmology © 2016 Huhtala et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Clinical Ophthalmology 2016:10 393–404 submit your manuscript | www.dovepress.com Dovepress 393 http://dx.doi.org/10.2147/OPTH.S99394 Dovepress ORIGINAL RESEARCH open access to scientific and medical research Open Access Full Text Article Femtosecond lasers for laser in situ keratomileusis: a systematic review and meta-analysis Anne Huhtala1 Juhani Pietilä1,2 Petri Mäkinen1,2 Hannu Uusitalo1–3 1Silmäasema Eye Hospital, 2SILK, Department of Ophthalmology, School of Medicine, University of Tampere, 3TAUH Eye Center, Tampere University Hospital, Tampere, Finland Purpose: The aim of this study was to review and meta-analyze whether there are differences between reported femtosecond (FS) lasers for laser-assisted in situ keratomileusis (LASIK) in terms of efficacy, predictability, and safety as primary outcomes and corneal flap thickness measurements and preand postoperative complications as secondary outcomes. Methods: A comprehensive literature search of PubMed, Science Direct, Scopus, and Cochrane CENTRAL Trials Library databases was conducted to identify the relevant prospective randomized controlled trials of FS lasers for LASIK. Thirty-one articles describing a total of 5,404 eyes were included. Results: Based on efficacy, IntraLase FS 10 and 30 kHz gave the best results. Based on predictability and safety, there were no differences between various FS lasers. FEMTO LDV and IntraLase FS 60 kHz produced the most accurate flap thicknesses. IntraLase and Wavelight SF200 had the fewest intraoperative complications. IntraLase, Visumax, and Wavelight FS200 had the most seldom postoperative complications. Conclusion: There were dissimilarities between different FS lasers based on efficacy and intraoperative and postoperative complications. All FS lasers were predictable and safe for making corneal flaps in LASIK. Keywords: femtosecond laser, laser in situ keratomileusis, LASIK, meta-analysis Introduction Laser-assisted in situ keratomileusis (LASIK) is the most commonly used refractive surgery technique for the correction of myopia, hyperopia, and astigmatism.1,2 The first phase of LASIK, the creation of a corneal flap, is the most critical step of LASIK, and it affects the visual outcome of the whole procedure. The flap creation is followed by excimer laser ablation of the exposed stroma after which the flap is repositioned. The technological evolution of flap creation has emerged from mechanical manually guided microkeratomes to automated microkeratomes and single-use microkeratomes, and most recently to femtosecond (FS) laser technology.3,4 In the FS laser technology, FS laser photodisrupts tissue at a preset depth and produces microcavitation bubbles consisting of water and carbon dioxide.5 The expansion of these bubbles separates the corneal lamellae and forms a resection plane.5 There are several FS lasers on the market. IntraLase, now produced by Abbott Medical Optics Inc. (Santa Ana, CA, USA), was the first FS laser keratome introduced in the USA in 2001.6 Technolas Femtosecond Workstation, formerly known as Femtec, by Technolas Perfect Vision (Munich, Germany), was introduced immediately after the market launch of IntraLase.7 FEMTO LDV by Ziemer Ophthalmic Systems (Port, Switzerland) was introduced in the late 2005, and Visumax by Carl Zeiss Meditec AG (Jena, Germany) in the fall 2006.7 Wavelight FS200 by Alcon Laboratories, Inc. (Fort Worth, TX, USA) Correspondence: Anne Huhtala Silmäasema Eye Hospital Tampere, Hämeenkatu 6, FIN-33100 Tampere, Finland Tel +358 50 304 0458 Email [email protected] Journal name: Clinical Ophthalmology Article Designation: ORIGINAL RESEARCH Year: 2016 Volume: 10 Running head verso: Huhtala et al Running head recto: Femtosecond lasers for LASIK DOI: http://dx.doi.org/10.2147/OPTH.S99394 Number of times this article has been viewed This article was published in the following Dove Press journal: Clinical Ophthalmology 7 March 2016
Clinical Ophthalmology 2016:10 submit your manuscript | www.dovepress.com Dovepress Dovepress 394 Huhtala et al received the US Food and Drug Administration clearance for marketing in the USA in the late 2010.8 FS laser technology has been increasingly used in LASIK. According to a poll conducted in 2006, .30% of the LASIK flaps were created by FS laser,9 while according to a MarketScope’s second-quarter survey for the year 2010, ∼70% of the LASIK flaps were created using an FS laser.10 As the published meta-analysis studies for FS lasers for LASIK have been concentrated only on IntraLase,10,11 the current study was undertaken to review and meta-analyze whether there are differences between reported FS lasers for LASIK in terms of efficacy, predictability, and safety as primary outcomes and corneal flap thickness measurements (difference from the target flap thickness and combined standard deviation [SD]) and complications as secondary outcomes. Materials and methods Literature search strategy Comprehensive literature searches of PubMed and Science Direct databases were first conducted on December 2, 2013. The literature search of Scopus database was conducted on March 10, 2014, and another literature search of the Cochrane CENTRAL Trials database on October 4, 2014. After the review process, all the databases were rechecked on December 28, 2015, for newer publications. The literature searches were conducted by using the following terms: “femtosecond laser lasik clinical controlled randomized” and “femtosecond laser lasik flap thickness controlled randomized” without date limitations. Language was restricted to English. Citations initially selected were first retrieved as titles by one reviewer (AH). After the initial screening, potentially relevant articles were retrieved as abstracts and screened by all authors. After this step, relevant articles were retrieved as complete papers and assessed for compliance. Quality scoring The quality of each study was assessed using the Jadad et al12 score with a scale of 0–5. Each study was assessed by three main aspects of study design: randomizing, masking, and participant withdrawals/dropouts. One point was given for the presence of randomizing, masking, and participant withdrawals/dropouts. If randomizing and blinding were appropriate, one additional point was added to each. Studies scoring ,3 points were considered to be of low quality. Outcome measures The primary outcome measures were efficacy, predictability, and safety. The efficacy measure was the proportion of eyes achieving an uncorrected distance visual acuity (UDVA), an UDVA of 20/20 or better. The predictability measure was refraction within ±0.5 diopters (D) of mean target spherical equivalent refraction. The safety measure was a loss of $2 Snellen lines of CDVA, a corrected distance visual acuity. Secondary outcome measures were flap thickness measurements (mean flap thickness and flap predictability as SD), and intraoperative and postoperative complication rates. For primary outcome measures, hyperopic eyes were excluded from the analysis. Statistical methods The data were pooled together for different FS lasers. Percentage values were calculated back to basic count values in order to make nonparametric analysis possible. Statistical significance for efficacy, predictability, safety, and intraand postoperative complications was evaluated with the chi-square test. Corneal flap thickness measurements were also pooled together and analyzed with the one-way analysis of variance (ANOVA) (SigmaPlot; Systat Software Inc., San Jose, CA, USA). In this meta-analysis, which included several previously published studies, P-value ,0.001 was considered significant. Results Results of the literature search Figure 1 shows the flowchart of the studies from the initial literature search to the final inclusion. Based on the full paper review, 21 controlled randomized trials and ten prospective or retrospective nonrandomized studies were included in the meta-analysis. Primary outcome measures Table 1 shows the main preoperative characteristics of the 31 studies describing a total of 5,404 eyes included in the meta-analysis. Studies written in bold (nine studies) have been included in the previously published meta-analysis studies10,11 concerning FS laser for LASIK. Postoperative characteristics for primary and secondary outcomes are presented in Table 2. Efficacy Among the different IntraLase types, the efficacy ranged from 85.1% (IntraLase FS 60 kHz, seven studies included13–19) to 100% (IntraLase FS 1020 and 30 kHz,21 Figure 2). For the most commonly reported IntraLase FS 60 kHz, the average efficacy was 85.1%. In one study, IntraLase FS 60 or 150 kHz22 was used and its efficacy was 98.3%. For IntraLase 150 kHz,19,23–25 the average
Clinical Ophthalmology 2016:10 submit your manuscript | www.dovepress.com Dovepress Dovepress 395 Femtosecond lasers for LASIK 5HSRUWLGHQWLILHGIURPOLWHUDWXUHVHDUFK •3XE0HG •6FLHQFH'LUHFW •6FRSXV •&RFKUDQH&(175$/7ULDOV/LEUDU\ $UWLFOHVH[FOXGHG •1RSULPDU\RXWFRPHV •1RVHFRQGDU\RXWFRPHV •1RSULPDU\DQGVHFRQGDU\RXWFRPHV •'XSOLFDWHGDWDVHWV 3DSHUVH[FOXGHG •'XSOLFDWHFLWDWLRQV •5HYLHZV •3RUWXJXHVH •&KLQHVH •,UUHOHYDQWUHSRUWV $UWLFOHVH[FOXGHGEDVHGRQDEVWUDFW $UWLFOHVFKRVHQIRUDEVWUDFWHYDOXDWLRQ $UWLFOHVFKRVHQIRU IXOOSDSHUUHYLHZ $UWLFOHVLQFOXGHG LQPHWDDQDO\VLV 6WXGLHVLQFOXGHGIURP SUHYLRXVPHWDDQDO\VHV Figure 1 Flowchart of study selection. efficacy was 93.7%. For FEMTO LDV,26,27 the average efficacy was 91.3%. For Visumax18,24,28 and Wavelight FS200,29,30 the average efficacy rates were 79.1% and 83.6%, respectively. Predictability The average predictability for the different IntraLase types ranged from 91.0% (IntraLase FS 60 kHz14–19) to 95.9% (IntraLase FS 30 kHz;21,31 Figure 3). FEMTO LDV26,27 had the average predictability of 89.4%. For Visumax18,24 and Wavelight FS200,29,30 the average predictabilities were 87.1% and 90.5%, respectively. Safety The average safety percentage was zero or very close to zero for all the studied FS laser types (Figure 4). For IntraLase FS 1532–36 and 30 kHz,21,31,37 the average safety was 0.4% and 0.7%, respectively. For IntraLase FS 60 kHz,13–18 it was 0.2%. For Wavelight FS 200,29,30 it was 0.5%. Secondary outcome measures Flap thickness measurements The average difference from the target flap thickness for IntraLase FS 3031,37 and 60 kHz13,14,16,38–40 was +0.8 and +0.6 µm, respectively (Figure 5). For IntraLase FS 15 kHz,33,34,41 the average difference from the target flap thickness was much bigger, +6.7 µm. For FEMTO LDV,26,40,42 the average difference from the target flap thickness was 5.3 µm less than intended. For Visumax,28,40 the difference from the target was 10.6 µm more than intended. Wavelight FS20029,30 produced corneal flaps that were close to the intended value (difference from the target flap thickness was +0.03 µm). The average SD for IntraLase FS 15 and 30 kHz was 15.5 and 13.8 µm, respectively. For the most
Clinical Ophthalmology 2016:10 submit your manuscript | www.dovepress.com Dovepress Dovepress 396 Huhtala et al Table 1 Characteristics of the studies included in the meta-analysis of femtosecond lasers for LASIK References (author, year) Surgical procedure Country Eyes (n) Preop mean SE (D) ± SD Follow-up (mo) Design Jadad et al12 quality score Tran et al, 200520 IntraLase FS 10 kHz USA 9 −2.58 3 Randomized 2 Durrie and Stahl, 200432 IntraLase FS 15 kHz USA 30 −4.66±1.73 (Custom Cornea) 1 Randomized 3 30 −4.83±1.71 (Zyoptix) Javaloy et al, 200733 IntraLase FS 15 kHz Spain 100 −3.98±1.89 3 Randomized 4 Chan et al, 200834 IntraLase FS 15 kHz USA 51 −3.76±1.41 12 Randomized 3 Durrie and Kezirian, 200550 IntraLase FS 15 kHz USA 51 −3.59 3 Randomized 3 Montes-Mico et al, 200721 IntraLase FS 30 kHz Spain 100 −2.85±1.79 6 Randomized 4 Patel et al, 200741 IntraLase FS 15 kHz USA 21 −4.02±1.61 6 Randomized 3 Munoz et al, 201035 IntraLase FS 15 kHz Spain 48 3.98±2.35 (defocus)a48 Randomized 4 Stonecipher and Kezirian, 200836 IntraLase FS 15 kHz USA 188 – (WF guided) 3 Randomized 1 186 – (WF optimized) Alio and Pinero, 200831 IntraLase FS 30 kHz Spain 22 −4.11±1.10 3 Randomized 5 Pfaeffl et al, 200837 IntraLase FS 30 kHz Germany 287 −4.1±3.6 Intraop Prospective interventional case study 1 Rosa et al, 200938 IntraLase FS 60 kHz Portugal 20 −4.48±2.55 3 Prospective cohort 1 20 −5.60±1.05 Slade et al, 200913 IntraLase FS 60 kHz USA 50 −3.96 6 Randomized 3 Prakash et al, 201014 IntraLase FS 60 kHz India 60 −5.70 1 Randomized 5 60 −6.09 60 −5.98 60 −5.13 Hatch et al, 201115 IntraLase FS 60 kHz USA 26 −4.34 6 Randomized 5 Prakash et al, 201116 IntraLase FS 60 kHz India 385 −6.08±2.7 12 Randomized 5 385 −5.99±2.8 He et al, 201417 IntraLase FS 60 kHz USA 55 −4.75±2.22 (WF guided) 12 Randomized 3 55 −4.81±1.95 (WF optimized) Zhai et al, 201339 IntraLase FS 60 kHz People’s Republic of China 59 −7.15±2.87 1 Randomized 4 Tanzer et al, 201322 IntraLase FS 60 or 150 kHz USA 544 −2.56 3 Prospective noncomparative two-site study 1 57 −0.34 30 +1.86 Yu and Manche, 201519 IntraLase FS 60 kHz USA 61 −4.66±2.30 12 Randomized 3 IntraLase FS 150 kHz 61 −4.62±2.32 Sales and Manche, 201323 IntraLase FS 150 kHz USA 36 −4.04±1.67 (WF guided) 12 Randomized 3 36 −3.99±1.71 (WF optimized) Yu and Manche, 201425 IntraLase FS 150 kHz USA 50 −3.89±1.67 (Allegretto Wave Eye-Q) 12 Prospective comparative case series 3 50 −4.18±1.73 (Visx Star Customvue S4 IR) Vryghem et al, 201026 FEMTO LDV Belgium 111 −4.91±2.45 6 Prospective, consecutive 1 Zhou et al, 201242 FEMTO LDV People’s Republic of China 360 −6.58±2.86 1 wk Randomized 2 Rosman et al, 201324 Visumax 500 kHz Singapore 45 −4.94±2.08 3 Randomized 5 IntraLase FS 150 kHz 45 −4.91±2.09 Ang et al, 201318 Visumax 500 kHz Singapore 381 −5.41±2.22 3 Retrospective case review 1 IntraLase FS 60 kHz 362 −5.34±2.28
Clinical Ophthalmology 2016:10 submit your manuscript | www.dovepress.com Dovepress Dovepress 397 Femtosecond lasers for LASIK Lim et al, 201328 Visumax 200 kHz Korea 36 −5.25±1.53 6 Randomized 5 36 −4.89±1.40 Kymionis et al, 201329 Wavelight AG/Alcon FS200 Greece 50 −4.15±1.69 6 Prospective nonrandomized interventional case series 3 Cummings et al, 201330 Wavelight FS200 Ireland 378 −4.03±2.29 3 Retrospective consecutive case series 1 53 +2.20±1.23 Ahn et al, 201140 IntraLase FS 60 kHz Korea 50 K=42.37±2.0 2 Comparative case series 3 Visumax 40 K=43.38±1.77 FEMTO LDV 64 K=43.31±1.48 Arbelaez et al, 200927 FEMTO LDV Sultanate of Oman 50 −3.08±2.32 (defocus)a6 Retrospective 1 Notes: aMean manifest defocus refraction as reported by the authors. Studies written in bold have been included in the previously published meta-analyses.10,11 Abbreviations: D, diopters; LASIK, laser-assisted in situ keratomileusis; SD, standard deviation; SE, refractive spherical equivalent; mo, months; WF, wave front; wk, weeks; preop, preoperative; intraop, intraoperative. Table 2 Postoperative outcome measures in the studies included in the meta-analysis of femtosecond lasers for LASIK References (author, year) Surgical procedure Primary outcomes Secondary outcomes Eyes (n) Efficacy (%) Predictability (%) Safety (%) Eyes (n) Target flap thickness (µm) Measured flap thickness (µm) ± SD (range) Method Intraop complication (%) Postop complication (%) Tran et al, 2005 20 IntraLase FS 10 kHz 7 100 –0 8 120 – – 0 37.5 Durrie and Stahl, 2004 32 IntraLase FS 15 kHz 30 93 83 0 30 110 – – – – 30 90 93 0 30 110 Javaloy et al, 2007 33 IntraLase FS 15 kHz 100 80 a 83 1 20 120 130.14±1.70 CM 0 17 Chan et al, 2008 34 IntraLase FS 15 kHz 40 98 93 3 51 120 118.7±12.2 SUP 0 28 (,1 mo) Durrie and Kezirian, 2005 50 IntraLase FS 15 kHz 51 98 90 –51 118 – – – – Montes-Mico et al, 2007 21 IntraLase FS 30 kHz 100 100 98 0 100 120 – – – – Patel et al, 2007 41 IntraLase FS 15 kHz 21 0.01±0.11 LogMar (20/20) 90 0.06±0.09 LogMar (20/15) 21 120 143±16 (110–172) CM 0 0 Munoz et al, 2010 35 IntraLase FS 15 kHz 48 85.4 97.9 0 48 120 – – 0 0 Stonecipher and Kezirian, 2008 36 IntraLase FS 15 kHz 188 93 (WF guided) 93 0 374 100–130 – – – – 186 93 (WF optimized) 94 0 Alio and Pinero, 2008 31 IntraLase FS 30 kHz 22 –86.4 a 13.6 a 22 110 115.95±6.22 VHF 0 0 Pfaeffl et al, 2008 37 IntraLase FS 30 kHz 287 – – 0 287 100 100.4±13.6 (57–138) OCP 0 2.8 Rosa et al, 2009 38 IntraLase FS 60 kHz 20 0.02±0.04 LogMar ––20 120 143.1±18.4 (107.2–172.5) SUP – – 20 0.04±0.03 LogMar 20 120 115.5±12.5 (91.6–147.8) 20 minutes (Continued)
Clinical Ophthalmology 2016:10 submit your manuscript | www.dovepress.com Dovepress Dovepress 398 Huhtala et al Table 2 (Continued) References (author, year) Surgical procedure Primary outcomes Secondary outcomes Eyes (n) Efficacy (%) Predictability (%) Safety (%) Eyes (n) Target flap thickness (µm) Measured flap thickness (µm) ± SD (range) Method Intraop complication (%) Postop complication (%) Slade et al, 2009 13 IntraLase FS 60 kHz 50 92 – 0 25 100 112±5 (87–118) OCT 0 0 Prakash et al, 2010 14 IntraLase FS 60 kHz 60 97 91.6 0 60 90 89.97±4.12 OCT 3.3 1.7 60 80 90 0 60 100 99.96±5.30 5 3.3 60 82 91.6 0 60 110 110.01±4.50 6.7 1.7 60 87 93.3 0 60 120 119.26±4.94 3.3 1.7 Hatch et al, 2011 15 IntraLase FS 60 kHz 25 92 88 0 26 90 – – 11.5 23.1 Prakash et al, 2011 16 IntraLase FS 60 kHz 368 82 95.1 0 368 90 90.1±6.7 (76–102) OCT 0 0 368 81 94.02 0 368 100 100.6±6.9 (85–114) 0 0 He et al, 2014 17 IntraLase FS 60 kHz 54 87 80 0 54 105 – (WF guided) SUP 0 0 54 78 72 1.9 54 105 – (WF optimized) Zhai et al, 2013 39 IntraLase FS 60 kHz 59 – – – 59 110 111±3 (104–120) OCT – – Tanzer et al, 2013 22 IntraLase FS 60 kHz or 150 kHz 497 98.2 – 0.4 544 – – – 0.2 0.2 48 100 – 0 57 – – – 23 b 95.7 b – 0 b 30 – – – Yu and Manche, 2015 19 IntraLase FS 60 kHz 61 93 95 2 61 105 – – 0 0 IntraLase FS 150 kHz 61 95 90 0 61 105 – – 0 0 Sales and Manche, 2013 23 IntraLase FS 150 kHz 34 97 94 0 34 105 – (WF guided) SUP – – 34 97 85 0 34 105 – (WF optimized) Yu and Manche, 2014 25 IntraLase FS 150 kHz 50 97.9 100 0 50 105 – (Allegretto Wave Eye-Q) SUP – – 50 91.5 92 0 50 105 – (Visx Star Customvue S4 IR) Vryghem et al, 2010 26 FEMTO LDV 111 94.6 95.5 0 111 110 106.68±12.68 (84–149) SUP 17.1 14.4 Zhou et al, 2012 42 FEMTO LDV 360 – – – 360 110 103.95±6.11 OCT – – Rosman et al, 2013 24 Visumax 500 kHz IntraLase FS 150 kHz 39 79.5 89.7 0 45 115 – SUP 13.3 0 39 82.1 84.6 0 45 110 – 2.2 0 Ang et al, 2013 18 Visumax 500 kHz 381 75.5 86.9 – 381 110–120 – – 2.1 0.3 IntraLase FS 60 kHz 362 75.0 87.3 – 362 100–110 – 0.3 0.6 Lim et al, 2013 28 Visumax 200 kHz 36 95.8 100 c 0 36 80 83.46±3.50 (73–95) OCT Only OBL 36 100 97.1 0 36 120 122.93±3.55 (107–131) Only OBL Kymionis et al, 2013 29 Wavelight AG/Alcon FS200 42 86 86 0 42 105 102.98±6.33 (91–114) OCT 4.8 0 Cummings et al, 2013 30 Wavelight FS200 378 83.4 91.0 0.3 431 120 120.23±13.94 (73–176) SOP 0 0 53 b 46.4 b 71.0 b 7.5 b Ahn et al, 2011 40 IntraLase FS 60 kHz 50 – – – 50 110 103.3±13.2 OCT – – Visumax 40 – – – 40 110 133.9±13.9 FEMTO LDV 64 – – – 64 110 105.8±8.2 Arbelaez et al, 2009 27 FEMTO LDV 50 84 76 d 0 50 110 – SOP 0 0 Notes: –, not reported; a estimated from a figure; b hyperopic eyes were excluded; c refraction within the ±0.25 D of target refraction; d only astigmatism correction. Studies written in bold have been included in the previously published meta-analyses. 10,11 Abbreviations: CM, confocal microscopy; LASIK, laser-assisted in situ keratomileusis; OBL, opaque bubble layer; OCP, optical coherence pachymetry; OCT, optical coherence tomography; SD, standard deviation; SOP, subtraction online pachymetry, difference between preoperative corneal thickness and the thickness of corneal bed after flap lifting; SUP, subtraction ultrasound pachymetry; VHF, very-high-frequency digital ultrasound; WF, wave front; postop, postoperative; intraop, intraoperative; mo, month.
Clinical Ophthalmology 2016:10 submit your manuscript | www.dovepress.com Dovepress Dovepress 399 Femtosecond lasers for LASIK 3UHGLFWDELOLW\ )6ODVHU ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] )(072/'9 9LVXPD[ :DYHOLJKW)6 $OO χ GI 3 QV 1XPEHURI VWXGLHV :LWKLQ 'WRWDO 0HDQ ± ± ± ± ± ± ± ± &, Figure 3 Predictability, the proportion of eyes within ±0.5 D of target refraction after FS laser for LASIK. Abbreviations: χ2, chi-square statistic; CI, confidence interval; D, diopters; df, degrees of freedom; FS, femtosecond; LASIK, laser-assisted in situ keratomileusis; ns, nonsignificant. (IILFDF\ )6ODVHU ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6RUN+] ,QWUD/DVH)6N+] )(072/'9 9LVXPD[ :DYHOLJKW)6 $OO χ GI 3 1XPEHURI VWXGLHV 8'9$ WRWDO 0HDQ ± ± ± ± ± ± ± ± ± ± &, Figure 2 Efficacy, the proportion of eyes within UDVA $20/20 after FS laser for LASIK. Abbreviations: χ2, chi-square statistic; CI, confidence interval; df, degrees of freedom; FS, femtosecond; LASIK, laser-assisted in situ keratomileusis; UDVA, uncorrected distance visual acuity. studied IntraLase FS 60 kHz, the average SD was 12.4 µm. For FEMTO LDV, the reproducibility, the average SD was 8.2 µm. For Visumax, the average SD was 23.3 µm and for Wavelight FS200 14.3 µm. Complication rates Among the different IntraLase types, IntraLase FS 10 kHz20 had no intraoperative complications, but postoperative complication rate was 37.5% (one study was included; Figures 6 and 7). IntraLase FS 15 kHz33–35,41 had no intraoperative complications, but the average postoperative complication rate was 18.0%. IntraLase FS 30 kHz31,37 had no intraoperative complications, while the percentage for postoperative complication was 2.6%. IntraLase FS 60 kHz13–19 had the average intraoperative and postoperative complication rates of 1.4% and 3.2%, respectively. IntraLase 150 kHz19,24 had the average intraoperative complication rate of 0.9% and postoperative complication rate of 0%. FEMTO LDV26,27 had the average intraoperative complication rate of 11.8%. The postoperative complication rate for FEMTO LDV averaged 9.9%. For Visumax,24,28 intraoperative and postoperative complication rates averaged 3.3% and 0.2%, respectively. Wavelight FS20029,30 had the lowest
Clinical Ophthalmology 2016:10 submit your manuscript | www.dovepress.com Dovepress Dovepress 400 Huhtala et al ± )6ODVHU ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] )(072/'9 9LVXPD[ :DYHOLJKW)6 $OO ) 3 QV 1XPEHU RIVWXGLHV 1XPEHU RIH\HV ± ± 'LIIHUHQFHIURP WDUJHWIODS WKLFNQHVVP 'LIIHUHQFHIURPWDUJHWIODSWKLFNQHVVP 6' P Figure 5 Corneal flap measurements after FS laser for LASIK. Abbreviations: F, F factor; FS, femtosecond; LASIK, laser-assisted in situ keratomileusis; ns, nonsignificant; SD, standard deviation. 6DIHW\ )6ODVHU ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6RUN+] ,QWUD/DVH)6N+] )(072/'9 9LVXPD[ :DYHOLJKW)6 $OO χ GI 3 QV 1XPEHURI VWXGLHV /RVVOLQHV WRWDO 0HDQ ± ± ± ± ± ± ± ± ± ± &, Figure 4 Safety, the proportion of eyes losing two or more Snellen lines of CDVA after FS laser for LASIK. Abbreviations: CDVA, corrected distance visual acuity; χ2, chi-square statistic; CI, confidence interval; df, degrees of freedom; FS, femtosecond; LASIK, laser-assisted in situ keratomileusis; ns, nonsignificant. intraoperative and postoperative complication rates of 0.4% and 0%, respectively. Discussion This meta-analysis compared different types of FS lasers for LASIK. In the literature search, we found 109 potentially relevant abstracts for review, but only 47 were suitable for a full paper review. Additionally, we included one study33 from the previously published meta-analyses.10,11 From these 48 articles, we excluded 17 papers based on lacking or duplicate data, and the final analysis included 31 articles. For primary outcome measures, hyperopic eyes were excluded. No studies were excluded from the analysis due to the lowquality scoring by Jadad et al system.12 The different FS laser systems can be classified into two groups: one group is characterized with high pulse energy–low pulse frequency (such as IntraLase and Femtec) and the other with low pulse energy–high pulse frequency (such as FEMTO LDV and Wavelight FS200).7 In the FS laser technology in the high pulse energy–low pulse frequency group, pulse energies are in the range of 1 µJ and repetition rates on the order of kilohertz.7 The low pulse energy–high pulse frequency system delivers only pulse energy on the order of nano-joule and uses megahertz repetition rates.7 From all FS lasers on the market, IntraLase was the first introduced and different IntraLase FS types (10, 15, 30, 60, and 150 kHz) are the most commonly reported.
Clinical Ophthalmology 2016:10 submit your manuscript | www.dovepress.com Dovepress Dovepress 401 Femtosecond lasers for LASIK ,QWUDRSHUDWLYHFRPSOLFDWLRQV )6ODVHU ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6RUN+] ,QWUD/DVH)6N+] )(072/'9 9LVXPD[ :DYHOLJKW)6 $OO χ GI 3 1XPEHURI VWXGLHV ,2 FRPSOLFDWLRQV WRWDO 0HDQ ± ± ± ± ± ± ± ± ± ± &, Figure 6 Intraoperative complications after FS laser for LASIK. Abbreviations: χ2, chi-square statistic; CI, confidence interval; df, degrees of freedom; FS, femtosecond; IO, intraoperative; LASIK, laser-assisted in situ keratomileusis. The pooled primary outcome results showed that there was a statistically significant difference in the proportion of eyes within a UDVA of 20/20 or better (efficacy). Based on efficacy, IntraLase and FEMTO LDV gave the best results. There were also statistically significant differences in the mean spherical equivalent refraction within ±0.5 D of target refraction (predictability). Based on predictability, IntraLase types FS 15, FS 30, and FS 60 kHz were the best. There was no statistically significant difference in the loss of $2 Snellen lines of CDVA (safety) between different FS lasers. It was difficult to combine the results of randomized controlled trials because of different follow-up times. In the 31 studies chosen for this meta-analysis, the follow-up time was #1 month in five studies.14,32,37,39,42 The most commonly reported follow-up times were 3 months (ten studies) 18,20,22,24,30,31,33,36,38,50 and 6 months (eight studies).13,15,21,26–29,41 The follow-up time was $1 year only in seven cases.16,17,19,23,25,34,35 Long follow-up times should be recommended for reporting refractive results, especially in controlled randomized studies. In the metaanalysis, different excimer laser choices used in LASIK made it also more difficult to compare refractive results. Another drawback of this meta-analysis is that due to limited reporting, the results were pooled together from standard, wavefrontguided, and wavefront-optimized treatments, and there was no compensation for this. 3RVWRSHUDWLYHFRPSOLFDWLRQV )6ODVHU ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6N+] ,QWUD/DVH)6RUN+] ,QWUD/DVH)6N+ )(072/'9 9LVXPD[ :DYHOLJKW)6 $OO χ GI 3 1XPEHURI VWXGLHV 32 FRPSOLFDWLRQV WRWDO 0HDQ ± ± ± ± ± ± ± ± ± ± &, Figure 7 Postoperative complications after FS laser for LASIK. Abbreviations: χ2, chi-square statistic; CI, confidence interval; df, degrees of freedom; FS, femtosecond; LASIK, laser-assisted in situ keratomileusis; PO, postoperative.