Influence of the flap on outcomes in corneal refractive surgery with femtosecond laser: SMILE vs. FLEx | Archivos de la Sociedad Española de Oftalmología (English Edition)

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The presence of a gland that produces a viscous secretion protecting the eye from desiccation during rapid dives has been described in some hawks." ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "J. González-Martín-Moro, J.L. Hernández-Verdejo, A. Clement-Corral" "autores" => array:3 [ 0 => array:2 [ "nombre" => "J." "apellidos" => "González-Martín-Moro" ] 1 => array:2 [ "nombre" => "J.L." "apellidos" => "Hernández-Verdejo" ] 2 => array:2 [ "nombre" => "A." 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POAGG: primary open angle glaucoma treatment group; CG: control group; IL-6: interleukin 6; pg/mg/ml: picograms per ml per miligram." ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "J. Benitez-del-Castillo Sánchez, M.D. Morillo-Rojas, C. Galbis-Estrada, M.D. Pinazo-Duran" "autores" => array:4 [ 0 => array:2 [ "nombre" => "J." "apellidos" => "Benitez-del-Castillo Sánchez" ] 1 => array:2 [ "nombre" => "M.D." "apellidos" => "Morillo-Rojas" ] 2 => array:2 [ "nombre" => "C." 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Alió, M. el Bahrawy, A. Angelov, D. Ortiz, P. Yébana" "autores" => array:5 [ 0 => array:4 [ "nombre" => "J.L." "apellidos" => "Alió" "email" => array:1 [ 0 => "jlalio@vissum.com" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "M." "apellidos" => "el Bahrawy" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] 2 => array:3 [ "nombre" => "A." "apellidos" => "Angelov" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "D." "apellidos" => "Ortiz" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "d" "identificador" => "aff0020" ] ] ] 4 => array:3 [ "nombre" => "P." "apellidos" => "Yébana" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:4 [ 0 => array:3 [ "entidad" => "VISSUM Instituto Oftalmológico de Alicante, Alicante, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "División de Oftalmología, Universidad Miguel Hernández, Alicante, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Resbiomed/VISSUM, Sofía, Bulgaria" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Departamento de Física Aplicada, Universidad de Cantabria, Santander, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Influencia del flap en los resultados en la cirugía refractiva corneal con láser de femtosegundo: SMILE vs. FLEx" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1033 "Ancho" => 1576 "Tamanyo" => 72496 ] ] "descripcion" => array:1 [ "en" => "Effects of biomechanical response on corneal curvature after the FLEx treatment." ] ] ] "textoCompleto" => "IntroductionThe concept of corneal refractive surgery through an intra-stromal lenticule without making a flap was already introduced in 1996 by Ito et al.<a class="elsevierStyleCrossRef" href="#bib0095">1</a> utilizing the picosecond laser in order to overcome the need of photoablation with excimer laser. This concept was studied in femtosecond laser trials without conclusive results in the clinic studies for both techniques. The concept was reintroduced by Carl Zeiss Meditec with the launch of the VisuMax femtosecond laser platform (Carl Zeiss Meditec, Jena, Germany) with the possibility of creating a lenticule by means of the Femtosecond Lenticule Extraction technique (FLEx). This technique consists in extracting the lenticule after raising the flap.<a class="elsevierStyleCrossRef" href="#bib0100">2</a> Numerous articles reporting satisfactory refractive results obtained with this technique were published in the next few years, leading to the introduction of a more advanced and less invasive technique, i.e., lenticule extraction through a small incision (small incision lenticule extraction, SMILE), a procedure that does not use a flap and was derived from the previous FLEx technique. The VisuMax femtosecond laser (the only commercially available platform designed for this purpose) creates a 3-D lenticule that is mechanically eliminated through a small lateral 2–3mm incision.<a class="elsevierStyleCrossRef" href="#bib0105">3</a> The difference between FLEx and SMILE provides an excellent model for researching the influence of the flap in corneal optical quality as its creation is the only difference between both procedures.Lenticule extraction refractive laser technique is a new generation in laser vision correction. Many authors have published comparable refractive and visual results with previous excimer laser techniques such as photorefractive keratectomy (PRK) laser in situ keratomileusis (Lasik) in terms of precision and stability,<a class="elsevierStyleCrossRef" href="#bib0110">4</a> as reported for the SMILE technique. SMILE obtained improvements in the postop dry eye syndrome and improvements are expected in the integrity of superficial corneal sensitivity due to the preservation of the anterior stroma nerve bundles.<a class="elsevierStyleCrossRef" href="#bib0115">5</a> On the other hand, mathematical models were applied to calculate that lenticule extraction laser refractive technique would possess superior postop biomechanical properties when compared to the Lasik technique.<a class="elsevierStyleCrossRef" href="#bib0120">6</a>The objective of the present study is to research whether the creation of a flap influences corneal optical quality in what concerns changes in the curvature radius (between the desired and obtained curvature) and aberrations, comparing the results of both femtosecond laser-assisted lenticular extraction techniques for correcting myopia, i.e. the flap-free SMILE technique and the FLEx that uses a flap. Said changes are partially and indirectly related to biomechanical changes in the cornea after the technique with or without flap.Patients and methodsDesign of the studyA prospective, non-randomized, consecutive and comparative study of a series of previously operated cases. All the patients who participated in the study signed an informed consent in accordance with the principles of the Helsinki Declaration and after a full explanation about the nature of the study and the procedure. The study was reviewed under the supervision of a Research Committee and the local Ethical Committee.PatientsThe study included 64 eyes with myopia and myopic astigmatism divided into groups: one group comprising 32 eyes that underwent surgery with the SMILE technique, and the other group comprising 32 eyes that underwent surgery with the FLEx technique. Both groups were paired on the basis of age, sex and presurgery myopic spherical equivalent. The study excluded patients with prior refractive surgery history (before refractive surgery with the SMILE or FLEx procedure) or who exhibited ocular disease, had a diagnostic of retinal or anterior segment diseases, contraindicated topography or pachymetry or with a range beyond the values required for refractive surgery, or were under 20 years of age.Surgical techniqueThe femtosecond laser for lenticular refractive surgery was utilized at the Resbiomed Ophthalmology Center (Sophia, Bulgaria) by 2 experienced and certified surgeons (J.L.A. and A.A.) who utilized the VisuMax femtosecond laser platform by Carl Zeiss Meditec (Jena, Germany). A full presurgery examination was performed as well as a refractive profile study. The SMILE and FLEx procedures were carried out under topical anesthesia, placing the patient under the curved contact lens of the platform through which suction was carried out. Photodisruption was performed with the femtosecond laser in order to create a 3-D intra-stromal lenticule with the standard parameters of the VisuMax (Carl Zeiss Meditec, Jena, Germany) platform software in the following manner: a thick cap at a depth of 100μs in the stroma, a diameter of 7.5mm, an optic zone of 6.5mm, repetition frequency of 500kHz, spot-and-track distance 4.5μs, and a 3mm lateral incision fixed at the 12 or’clock angle. Subsequently, a spatula was utilized for dissecting the anterior and posterior surface of the lenticule and forceps to hold and extract the lenticule through the lateral incision. A similar procedure was used for the FLEx technique with the exception that an additional 120μs flap was made. All groups were prescribed postoperative topical treatment with lubricant steroids and antibiotic drops.The entire post-surgery follow-up was carried out by independent observers over a three-month period. All the visits included a complete biomicroscopy examination with slit lamp and uncorrected and best corrected visual acuity measurement with the standardized Snellen test. The topographic measures were taken with theATLAS 9000 topograph by Zeiss Meditec (Jena, Germany). The data reported in this study correspond to a postoperative follow-up of 3 months.Biomechanical response calculationsThe post-treatment curvature change percentage<a class="elsevierStyleCrossRef" href="#bib0125">7</a> was characterized considering the difference between the target ratio and that obtained after surgery, as follows:<elsevierMultimedia ident="eq0005"></elsevierMultimedia>where Rpost is the post-surgery corneal radius one month after surgery, measured with the corneal topograph, and Rs is the surgery radius sculpted by the laser in the stroma (5mm diameter), that is the desired or target post-surgery corneal radius. Mathematically, the calculation involved subtracting the formulae of the corneal spherical surface ablation depth prior to surgery. Rpost (measured) is the post-surgery corneal radius measured 3 months after surgery with a topograph. Said post-surgery radius is the mean radius of the 5 millimeters (central) provided by the topograph.The C-coefficient characterizes corneal curvature changes due to the biomechanical response of the corneal surface after the cutting or extraction of the lenticule with the FLEx and SMILE techniques. The meaning of C is determined by its sign: C>0 implies flattening (Rpost>Rs), that would be related to over-refraction; and C<0 implies increased curving (Rpost<Rs) and would therefore be related to hypo-correction.The main assessment criteria were the mean value of the corneal curvature change coefficient, C, and the ratio and correlation between the post-surgery corneal radius (measured one month after surgery) and the surgical (or target) radius.Corneal aberrometryCorneal aberrations were obtained from the data of the anterior corneal surface with the ATLAS 9000 Zeiss Meditec (Jena, Germany) topograph, which provides data of the corneal wavefront through the Zernike polynomial with increase up to the 7th order. In order to evaluate corneal aberration changes, we measured the root-mean-square (RMS) values of the total wavefront, comma Z(3±1), spherical aberration Z(4.0) (described with its symbol), astigmatism Z(2±2) and high order aberrations (HOA) with an aperture diameter of 10mm in the pre-and post-surgery visits after 3 months follow-up.Statistical analysisThe statistical analysis was carried out using IBM SPSS version 22.0.0 for Windows (SPSS Inc, Chicago, Illinois, USA). The T for student test for paired samples was applied for comparing the mean value between the 2 study groups and between the pre- and post-surgery visits. Minimum squared adjustment, characterized by Pearson's correlation coefficient (R), was utilized for obtaining the linear adjustment of the ratio between the different curvature radius. Statistical tests were carried out with a confidence interval of 95%.ResultsThe study included 2 groups: one SMILE group (without a flap) with 32 eyes of 16 patients (50% females), a mean age of 34 years (range: from 23 to 49 years) and a mean spherical equivalent of −4.59D (range: from −2.25 to −8.25D), and a FLEx group (with flap) comprising 32 eyes of 16 patients (50% females) with a mean age of 31.53 years (range: 22.38) and a mean spherical equivalent of −4.57 D (range: from −1.50 to −9.25D). <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows the visual and refractive results of both groups in terms of safety, efficacy and prediction.<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>The mean percentage of curvature radius change, C, was −1.77±1.72% for the SMILE group and −2.03±2.82% for the FLEx group. No statistically significant differences were found between the 2 groups (p=0.655). <a class="elsevierStyleCrossRefs" href="#fig0005">Figs. 1 and 2</a> show the ratio between the final corneal radius, Rpost (measured 3 months after surgery) and the radius sculpted in the corneal stroma, Rs, for the SMILE group and the FLEx group, respectively. A good correlation was found for the final adjustment in both groups, as follows: SMILE, Rpost=0.84Rs+1.2 (r=0.95); FLEx, Rpost=0.71Rs+2.3 (r=0.86). The higher correlation for the SMILE group demonstrates better prediction in refractive results after surgery.<elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a> compares corneal topography presurgery and 3 months after the SMILE and FLEx treatments. The maps showed that the FLEx technique causes more topographic changes in the corneal periphery than the SMILE treatment. The SMILE group exhibited a statistically significant reduction in the mean corneal astigmatism (1.37±1.44D presurgery; 0.81±0.53D 3 months post-surgery; p=0.02), whereas the FLEx group did not exhibit statistically significant differences (1.01±0.79D presurgery; 0.97±0.51D 3 months post-surgery; p=0.765).<elsevierMultimedia ident="fig0015"></elsevierMultimedia><a class="elsevierStyleCrossRefs" href="#fig0020">Figs. 4 and 5</a> show the evolution of corneal aberrations after the SMILE and FLEx treatments, respectively. Both groups exhibited a statistically significant increase in the RMS value for total corneal aberration: from 4.0±2.7 to 8.1±3.6μm in the SMILE group (t-test; p<0.00001), and from 4.5±3.0 to 9.4±4.4μm in the FLEx group (t-test; p<0.00001). Post-surgery RMS values were slightly higher with the FLEx treatment but the difference was not statistically significant (p=0.097). The individualized analysis of Zernike polynomials demonstrated significant increase for astigmatism, coma and spherical aberration in both groups (p<0.05 for all comparisons). However, for the SMILE group no statistically significant differences were found in the RMS value for HOA (1.05±1.15 presurgery and 1.41±0.84μm post-surgery; p=0.077). The FLEx technique exhibited a significant increase in HOA after treatment (1.00±1.07 presurgery and 1.93±1.46μm postsurgery; p=0.006). In this case, the difference between the post-surgery HOA values in the SMILE and FLEx was statistically significant (p=0.04).<elsevierMultimedia ident="fig0020"></elsevierMultimedia><elsevierMultimedia ident="fig0025"></elsevierMultimedia>DiscussionThe use of a flap in corneal refractive surgery has received special attention in the recent history of corneal refractive surgery. Femtosecond-assisted lenticular extraction for correcting myopia can be carried out with a technique utilizing a corneal flap (FLEx) or without said flap (SMILE). This produces an excellent model for analyzing the actual influence of making a flap in refractive surgery results. The recent global interest in the new and innovative generation of femtosecond laser correction has given rise to a large number of clinical studies. Numerous articles<a class="elsevierStyleCrossRefs" href="#bib0130">8–10</a> have demonstrated the stability of femtosecond laser in corneal refractive surgery. Blum et al.<a class="elsevierStyleCrossRef" href="#bib0135">9</a> published a study with 5 years follow-up of 108 eyes treated with FLEx. In the results of said study, 100% of eyes obtained refractive results within 1.0D and 73% within 0.50D, without loss of visual acuity lines and a mean regression of 0.07D.Ivarsen et al.<a class="elsevierStyleCrossRef" href="#bib0140">10</a> published the results of 1574 eyes submitted to SMILE, with a mean spherical equivalent of −7.25±1.84D, mean post-surgery refraction of −0.28±0.52D, and mean treatment error of −0.15±0.50D after 3 months follow-up, 86% (1346 eyes) exhibited corrected visual acuity without changes or improved. A loss of 2 or more lines was observed in 1.5% of eyes. The refractive results of the present FLEx and SMILE groups (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>) match the results mentioned above and those of other authors who demonstrated the precision and stability of lenticular extraction refractive surgery with femtosecond laser<a class="elsevierStyleCrossRef" href="#bib0145">11</a>.In Europe, a refractive correction of −3.0 to −8.0D was accepted as reference for femtosecond-assisted lenticular extraction refractive surgery. However, some authors<a class="elsevierStyleCrossRef" href="#bib0150">12</a> reported that the SMILE is as safe and effective for correcting slight myopia, as low as 1D, comparing results with LASIK treatment for the same range. On the other hand, a number of experienced researchers began to research these techniques in patients with high myopia of up to −14.0D.The SMILE technique without a flap has demonstrated to be superior in comparison to other techniques in some aspects such as improved lacrimal film and ocular surface condition. Xu and Yang<a class="elsevierStyleCrossRef" href="#bib0155">13</a> reported that while the first post-surgery parameters (Schirmer test, tear breakup time and McMonnies score) exhibited poor results in patients who underwent the SMILE and Lasik treatments, the SMILE patients recovered the presurgery baseline levels in comparison with the LASIK patients who did not recover previous baseline levels. It is thought that this could be due to diminished damage caused by the SMILE technique in the density of the superficial nerve fibers of the cornea and therefore with better preservation of post-surgery corneal sensitivity, which has been demonstrated with confocal microscopy.<a class="elsevierStyleCrossRefs" href="#bib0160">14,15</a>On the basis of the general interest in surgeries without flaps, many researchers have studied the effect of the absence of a flap in the SMILE technique as regards the improvement of the post-surgery corneal biomechanics. Randleman et al.<a class="elsevierStyleCrossRef" href="#bib0170">16</a> indicated that the cohesive tension of the stroma is based on the way in which the lamellar structure of the stroma remains united, which diminishes from the anterior to the posterior part in the central region of the cornea. On the basis of this concept, Reinstein et al.<a class="elsevierStyleCrossRef" href="#bib0120">6</a> utilized a mathematical model to demonstrate that the post-surgery traction resistance should be greater after the SMILE treatment when compared to Lasik and PRK because the strongest laminar layer, i.e., the anterior layer, remains intact. This result means that the SMILE treatment is capable of correcting higher myopia with a better safety profile.Similarly, in a previous article<a class="elsevierStyleCrossRef" href="#bib0125">7</a> the authors have used a mathematical model for measuring unexpected changes in corneal curvature as an indirect method for evaluating alterations in the biomechanical response of the cornea. This article compares to LASIK modes, i.e., mechanic microkeratome and the femtosecond-assisted microkeratome. The mathematical model is based on the concept that the corneal curvature obtained after treatment differs from the desired presurgery treatment due to several factors related to the biomechanical response of the corneal surface after making and repositioning the flap. Said biomechanical response can theoretically be evaluated by studying the variation between the nominal sculpted radius (or surgical radius) and the corneal radius of the eye after surgery. The present study found that refractive change in the corneal curvature is lower after femtosecond-assisted LASIK surgery than after the LASIK technique with the mechanical microkeratome.The analysis of results utilizing said mathematical model in the 2 groups of the present study indicated that the differences between the mean values and standard deviation of the change coefficient of corneal curvature between that obtained and the desired curvature in the SMILE and FLEx groups were not statistically significant. However, high correlation and low standard deviation in the SMILE group indicated better prediction and more consistent results for the desired vis-à-vis the obtained curvature ratio despite the fact that said differences were not significant as regards the refractive and visual results.In what concerns corneal optical quality, both treatments produced increases in the RMS values of high order aberrations, as could be expected after a refractive surgery procedure. However, the FLEx technique, based on the flap, induces higher degradation of corneal optical quality in terms of HOA in comparison with the SMILE treatment which does not require a flap. These results are consistent with previous studies on the optical aberrations induced by the flap after refractive surgery.<a class="elsevierStyleCrossRefs" href="#bib0175">17,18</a>In conclusion, in accordance with the model described in this paper, the mean refractive change in corneal curvature related to the biomechanical response of the corneal surface after cutting and extracting the lenticule was similar in both surgical modes, with and without a flap, i.e., the FLEx and SMILE techniques. However, the FLEx procedure, which requires making a flap, exhibited a tendency which, despite not being significant, indicated high degradation of corneal optical quality vis-à-vis the induction of HOA. This finding points to a tendency toward a better prediction in surgeries that do not require a flap even though refractive or visual differences were not observed between the 2 groups of this study. Accordingly, the influence of the flap seems to have little relevance for the refractive and aberrometric results of femtosecond-assisted lenticular extraction according to the results of the study. However, the findings indirectly indicate that the SMILE, flap-free surgery is biomechanically more consistent. The authors consider that more studies are needed to assess other potential advantages of the results obtained with the current corneal refractive surgery without flaps.Conflict of interestsThe authors state that there is no conflict of interest and that they have no interest in the property of the materials mentioned in the present article." "textoCompletoSecciones" => array:1 [ "secciones" => array:10 [ 0 => array:3 [ "identificador" => "xres833048" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec828970" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres833047" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec828971" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Patients and methods" "secciones" => array:6 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Design of the study" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Patients" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Surgical technique" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Biomechanical response calculations" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Corneal aberrometry" ] 5 => array:2 [ "identificador" => "sec0040" "titulo" => "Statistical analysis" ] ] ] 6 => array:2 [ "identificador" => "sec0045" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0050" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0055" "titulo" => "Conflict of interests" ] 9 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2016-06-09" "fechaAceptado" => "2016-10-08" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec828970" "palabras" => array:5 [ 0 => "Optical quality" 1 => "Corneal refractive surgery" 2 => "Small incision lenticule extraction" 3 => "Femtosecond lenticule extraction" 4 => "Corneal flap" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec828971" "palabras" => array:5 [ 0 => "Calidad óptica" 1 => "Cirugía refractiva corneal" 2 => "Extracción lenticular de pequeña incisión" 3 => "Extracción lenticular con láser femtosegundo" 4 => "Flap corneal" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "ObjectiveTo investigate the influence of creating a flap on the postoperative optical quality of the cornea in terms of predicted corneal curvature and Seidel aberrations after 2 modalities of femtosecond assisted corneal lenticule extraction laser for the correction of myopia and myopic astigmatism: the flapless procedure small incision lenticular extraction (SMILE) and the flap-based femtosecond lenticular extraction (FLEx). MethodsThe study is a prospective consecutive non-randomized comparative interventional case series including 64 eyes with myopic or myopic astigmatism refractive errors. Patients were divided into 2 groups matched for age, sex and myopia. One group underwent SMILE treatment and the other underwent FLEx treatment. Seidel aberrations root-mean-square values were obtained with a 10mm aperture using the ATLAS 9000 topographer before surgery and 3 months after surgery. The relationship between the post-surgical corneal radius and the predicted sculpted radius were analyzed in each group. ResultsThe mean percentage change in the curvature radius was −2.03% in the FLEx group and −1.77% in the SMILE group (p=0.655). The higher correlation for the SMILE group demonstrates a better predictability after the surgery. As regards corneal aberrations, the FLEx treatment showed a greater increase of higher order aberrations than SMILE treatment (p=0.04). ConclusionThe mean refractive change in corneal curvature, which is indirectly related to the biomechanical response of the corneal surface after the lenticule cut and extraction, was similar after both treatments. However, the flap based FLEx procedure showed a greater degradation of the corneal optical quality in terms of induction of higher order aberrations." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "ObjetivoInvestigar la influencia de la creación de un flap corneal en la calidad óptica posquirúrgica en términos de predicción de la curvatura corneal y las aberraciones de Seidel tras 2 modalidades de extracción lenticular corneal asistidas por láser de femtosegundo para la corrección de miopía y astigmatismo miópico: la técnica de extracción lenticular de pequeña incisión sin flap (SMILE) y la extracción lenticular con femtosegundo mediante la creación de un flap (FLEx). MétodosEstudio prospectivo consecutivo no aleatorizado comparativo de una serie de casos previamente intervenidos, incluyendo 64 ojos con un error refractivo de miopía y astigmatismo miópico. Los pacientes fueron divididos en 2 grupos en función de la edad, sexo y miopía: un grupo tratado con SMILE y otro tratado con FLEx. Los valores de las aberraciones de Seidel root-mean-square fueron obtenidos en la visita preoperatoria y 3meses después de la cirugía con una apertura de 10mm usando el topógrafo ATLAS 9000. La relación entre el radio corneal posquirúrgico real y el radio pretendido fue analizada para cada uno de los grupos. ResultadosEl porcentaje medio de cambio en la curvatura corneal fue de −2,03% en el grupo FLEx y de −1,77% en el grupo SMILE (p=0,655). La elevada correlación en el grupo SMILE muestra una predicción mejor después de la cirugía. Respecto a las aberraciones corneales, el tratamiento FLEx mostró un mayor incremento de las aberraciones de alto orden que el tratamiento SMILE (p=0,04). ConclusionesEl cambio refractivo medio en la curvatura corneal, indirectamente relacionado con la respuesta biomecánica de la superficie corneal tras el corte y extracción del lentículo, fue similar después de ambos tratamientos. Sin embargo, la técnica FLEx basada en la creación del flap mostró una mayor degradación en la calidad óptica corneal respecto a la inducción de aberraciones de alto orden." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Alió JL, el Bahrawy M, Angelov A, Ortiz D, Yébana P. Influencia del flap en los resultados en la cirugía refractiva corneal con láser de femtosegundo: SMILE vs. FLEx. Arch Soc Esp Oftalmol. 2017;92:218–224." ] ] "multimedia" => array:7 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1016 "Ancho" => 1543 "Tamanyo" => 72374 ] ] "descripcion" => array:1 [ "en" => "Effects of biomechanical response on corneal curvature after the SMILE treatment." ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1033 "Ancho" => 1576 "Tamanyo" => 72496 ] ] "descripcion" => array:1 [ "en" => "Effects of biomechanical response on corneal curvature after the FLEx treatment." ] ] 2 => array:7 [ "identificador" => "fig0015" "etiqueta" => "Fig. 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 1785 "Ancho" => 2252 "Tamanyo" => 448896 ] ] "descripcion" => array:1 [ "en" => "Corneal topography maps of an eye prior to surgery (left) and 3 months after surgery (right) with the SMILE treatment (above) and FLEx (below). G" ] ] 3 => array:7 [ "identificador" => "fig0020" "etiqueta" => "Fig. 4" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr4.jpeg" "Alto" => 1138 "Ancho" => 1415 "Tamanyo" => 72250 ] ] "descripcion" => array:1 [ "en" => "Corneal aberrations (RMS values) for an aperture diameter of 10mm, at presurgery and 3 months after SMILE treatment." ] ] 4 => array:7 [ "identificador" => "fig0025" "etiqueta" => "Fig. 5" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr5.jpeg" "Alto" => 1130 "Ancho" => 1422 "Tamanyo" => 68074 ] ] "descripcion" => array:1 [ "en" => "Corneal aberrations (RMS values) for an aperture diameter of 10mm, at presurgery and 3 months after FLEx treatment." ] ] 5 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="center" valign="top" scope="col" style="border-bottom: 2px solid black">SMILE % \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="center" valign="top" scope="col" style="border-bottom: 2px solid black">FLEx % \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " colspan="3" align="left" valign="top">Safety</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">20/20 or better \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">93.75 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">87.5 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">20/25 or better \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">20/40 or better \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="3" align="left" valign="top">Efficacy</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Without loss of lines \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">96.87 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">81.25 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Loss of over 2 lines \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Gain of lines \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">18.75 (1 line) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">12.50 (1–2 lines) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="3" align="left" valign="top">Results</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">% of cases ±0.5D \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">71.87 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">84.43 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">% of cases ±1.0D \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">90.62 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1403202.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Visual and refractive results of the 2 study groups." ] ] 6 => array:5 [ "identificador" => "eq0005" "tipo" => "MULTIMEDIAFORMULA" "mostrarFloat" => false "mostrarDisplay" => true "Formula" => array:5 [ "Matematica" => "C=Rpost−RsRs×100" "Fichero" => "STRIPIN_si1.jpeg" "Tamanyo" => 1450 "Alto" => 34 "Ancho" => 137 ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:18 [ 0 => array:3 [ "identificador" => "bib0095" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Picosecond laser in situ keratomileusis with a 1053-nm Nd:YLF laser" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "M. 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Influence of the flap on outcomes in corneal refractive surgery with femtosecond laser: SMILE vs. FLEx

Influencia del flap en los resultados en la cirugía refractiva corneal con láser de femtosegundo: SMILE vs. FLEx

J.L. Alióa,b,

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jlalio@vissum.com

Corresponding author.

, M. el Bahrawya, A. Angelovc, D. Ortizd, P. Yébanaa

a VISSUM Instituto Oftalmológico de Alicante, Alicante, Spain

b División de Oftalmología, Universidad Miguel Hernández, Alicante, Spain

c Resbiomed/VISSUM, Sofía, Bulgaria

d Departamento de Física Aplicada, Universidad de Cantabria, Santander, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">The concept of corneal refractive surgery through an intra-stromal lenticule without making a flap was already introduced in 1996 by Ito et al&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">1</span></a> utilizing the picosecond laser in order to overcome the need of photoablation with excimer laser&#46; This concept was studied in femtosecond laser trials without conclusive results in the clinic studies for both techniques&#46; The concept was reintroduced by Carl Zeiss Meditec with the launch of the VisuMax femtosecond laser platform &#40;Carl Zeiss Meditec&#44; Jena&#44; Germany&#41; with the possibility of creating a lenticule by means of the Femtosecond Lenticule Extraction technique &#40;FLEx&#41;&#46; This technique consists in extracting the lenticule after raising the flap&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">2</span></a> Numerous articles reporting satisfactory refractive results obtained with this technique were published in the next few years&#44; leading to the introduction of a more advanced and less invasive technique&#44; i&#46;e&#46;&#44; lenticule extraction through a small incision &#40;<span class="elsevierStyleItalic">small incision lenticule extraction</span>&#44; SMILE&#41;&#44; a procedure that does not use a flap and was derived from the previous FLEx technique&#46; The VisuMax femtosecond laser &#40;the only commercially available platform designed for this purpose&#41; creates a 3-D lenticule that is mechanically eliminated through a small lateral 2&#8211;3<span class="elsevierStyleHsp" style=""></span>mm incision&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">3</span></a> The difference between FLEx and SMILE provides an excellent model for researching the influence of the flap in corneal optical quality as its creation is the only difference between both procedures&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Lenticule extraction refractive laser technique is a new generation in laser vision correction&#46; Many authors have published comparable refractive and visual results with previous excimer laser techniques such as photorefractive keratectomy &#40;PRK&#41; laser in situ keratomileusis &#40;Lasik&#41; in terms of precision and stability&#44;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">4</span></a> as reported for the SMILE technique&#46; SMILE obtained improvements in the postop dry eye syndrome and improvements are expected in the integrity of superficial corneal sensitivity due to the preservation of the anterior stroma nerve bundles&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">5</span></a> On the other hand&#44; mathematical models were applied to calculate that lenticule extraction laser refractive technique would possess superior postop biomechanical properties when compared to the Lasik technique&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">6</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The objective of the present study is to research whether the creation of a flap influences corneal optical quality in what concerns changes in the curvature radius &#40;between the desired and obtained curvature&#41; and aberrations&#44; comparing the results of both femtosecond laser-assisted lenticular extraction techniques for correcting myopia&#44; i&#46;e&#46; the flap-free SMILE technique and the FLEx that uses a flap&#46; Said changes are partially and indirectly related to biomechanical changes in the cornea after the technique with or without flap&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Patients and methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Design of the study</span><p id="par0020" class="elsevierStylePara elsevierViewall">A prospective&#44; non-randomized&#44; consecutive and comparative study of a series of previously operated cases&#46; All the patients who participated in the study signed an informed consent in accordance with the principles of the Helsinki Declaration and after a full explanation about the nature of the study and the procedure&#46; The study was reviewed under the supervision of a Research Committee and the local Ethical Committee&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Patients</span><p id="par0025" class="elsevierStylePara elsevierViewall">The study included 64 eyes with myopia and myopic astigmatism divided into groups&#58; one group comprising 32 eyes that underwent surgery with the SMILE technique&#44; and the other group comprising 32 eyes that underwent surgery with the FLEx technique&#46; Both groups were paired on the basis of age&#44; sex and presurgery myopic spherical equivalent&#46; The study excluded patients with prior refractive surgery history &#40;before refractive surgery with the SMILE or FLEx procedure&#41; or who exhibited ocular disease&#44; had a diagnostic of retinal or anterior segment diseases&#44; contraindicated topography or pachymetry or with a range beyond the values required for refractive surgery&#44; or were under 20 years of age&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Surgical technique</span><p id="par0030" class="elsevierStylePara elsevierViewall">The femtosecond laser for lenticular refractive surgery was utilized at the Resbiomed Ophthalmology Center &#40;Sophia&#44; Bulgaria&#41; by 2 experienced and certified surgeons &#40;J&#46;L&#46;A&#46; and A&#46;A&#46;&#41; who utilized the VisuMax femtosecond laser platform by Carl Zeiss Meditec &#40;Jena&#44; Germany&#41;&#46; A full presurgery examination was performed as well as a refractive profile study&#46; The SMILE and FLEx procedures were carried out under topical anesthesia&#44; placing the patient under the curved contact lens of the platform through which suction was carried out&#46; Photodisruption was performed with the femtosecond laser in order to create a 3-D intra-stromal lenticule with the standard parameters of the VisuMax &#40;Carl Zeiss Meditec&#44; Jena&#44; Germany&#41; platform software in the following manner&#58; a thick cap at a depth of 100<span class="elsevierStyleHsp" style=""></span>&#956;s in the stroma&#44; a diameter of 7&#46;5<span class="elsevierStyleHsp" style=""></span>mm&#44; an optic zone of 6&#46;5<span class="elsevierStyleHsp" style=""></span>mm&#44; repetition frequency of 500<span class="elsevierStyleHsp" style=""></span>kHz&#44; <span class="elsevierStyleItalic">spot-and-track distance</span> 4&#46;5<span class="elsevierStyleHsp" style=""></span>&#956;s&#44; and a 3<span class="elsevierStyleHsp" style=""></span>mm lateral incision fixed at the 12 or&#8217;clock angle&#46; Subsequently&#44; a spatula was utilized for dissecting the anterior and posterior surface of the lenticule and forceps to hold and extract the lenticule through the lateral incision&#46; A similar procedure was used for the FLEx technique with the exception that an additional 120<span class="elsevierStyleHsp" style=""></span>&#956;s flap was made&#46; All groups were prescribed postoperative topical treatment with lubricant steroids and antibiotic drops&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The entire post-surgery follow-up was carried out by independent observers over a three-month period&#46; All the visits included a complete biomicroscopy examination with slit lamp and uncorrected and best corrected visual acuity measurement with the standardized Snellen test&#46; The topographic measures were taken with the</p><p id="par0040" class="elsevierStylePara elsevierViewall">ATLAS 9000 topograph by Zeiss Meditec &#40;Jena&#44; Germany&#41;&#46; The data reported in this study correspond to a postoperative follow-up of 3 months&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Biomechanical response calculations</span><p id="par0045" class="elsevierStylePara elsevierViewall">The post-treatment curvature change percentage<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">7</span></a> was characterized considering the difference between the target ratio and that obtained after surgery&#44; as follows&#58;<elsevierMultimedia ident="eq0005"></elsevierMultimedia>where <span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">post</span></span> is the post-surgery corneal radius one month after surgery&#44; measured with the corneal topograph&#44; and <span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">s</span></span> is the surgery radius sculpted by the laser in the stroma &#40;5<span class="elsevierStyleHsp" style=""></span>mm diameter&#41;&#44; that is the desired or target post-surgery corneal radius&#46; Mathematically&#44; the calculation involved subtracting the formulae of the corneal spherical surface ablation depth prior to surgery&#46; <span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">post</span></span> &#40;measured&#41; is the post-surgery corneal radius measured 3 months after surgery with a topograph&#46; Said post-surgery radius is the mean radius of the 5 millimeters &#40;central&#41; provided by the topograph&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The <span class="elsevierStyleItalic">C</span>-coefficient characterizes corneal curvature changes due to the biomechanical response of the corneal surface after the cutting or extraction of the lenticule with the FLEx and SMILE techniques&#46; The meaning of <span class="elsevierStyleItalic">C</span> is determined by its sign&#58; <span class="elsevierStyleItalic">C</span><span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0 implies flattening &#40;<span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">post</span></span><span class="elsevierStyleItalic"><span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">s</span></span>&#41;&#44; that would be related to over-refraction&#59; and <span class="elsevierStyleItalic">C</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0 implies increased curving &#40;<span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">post</span></span><span class="elsevierStyleItalic"><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">s</span></span>&#41; and would therefore be related to hypo-correction&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The main assessment criteria were the mean value of the corneal curvature change coefficient&#44; <span class="elsevierStyleItalic">C</span>&#44; and the ratio and correlation between the post-surgery corneal radius &#40;measured one month after surgery&#41; and the surgical &#40;or target&#41; radius&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Corneal aberrometry</span><p id="par0060" class="elsevierStylePara elsevierViewall">Corneal aberrations were obtained from the data of the anterior corneal surface with the ATLAS 9000 Zeiss Meditec &#40;Jena&#44; Germany&#41; topograph&#44; which provides data of the corneal wavefront through the Zernike polynomial with increase up to the 7th order&#46; In order to evaluate corneal aberration changes&#44; we measured the root-mean-square &#40;RMS&#41; values of the total wavefront&#44; comma <span class="elsevierStyleItalic">Z</span>&#40;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#41;&#44; spherical aberration <span class="elsevierStyleItalic">Z</span>&#40;4&#46;0&#41; &#40;described with its symbol&#41;&#44; astigmatism <span class="elsevierStyleItalic">Z</span>&#40;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#41; and high order aberrations &#40;HOA&#41; with an aperture diameter of 10<span class="elsevierStyleHsp" style=""></span>mm in the pre-and post-surgery visits after 3 months follow-up&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Statistical analysis</span><p id="par0065" class="elsevierStylePara elsevierViewall">The statistical analysis was carried out using IBM SPSS version 22&#46;0&#46;0 for Windows &#40;SPSS Inc&#44; Chicago&#44; Illinois&#44; USA&#41;&#46; The <span class="elsevierStyleItalic">T</span> for student test for paired samples was applied for comparing the mean value between the 2 study groups and between the pre- and post-surgery visits&#46; Minimum squared adjustment&#44; characterized by Pearson&#39;s correlation coefficient &#40;<span class="elsevierStyleItalic">R</span>&#41;&#44; was utilized for obtaining the linear adjustment of the ratio between the different curvature radius&#46; Statistical tests were carried out with a confidence interval of 95&#37;&#46;</p></span></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Results</span><p id="par0070" class="elsevierStylePara elsevierViewall">The study included 2 groups&#58; one SMILE group &#40;without a flap&#41; with 32 eyes of 16 patients &#40;50&#37; females&#41;&#44; a mean age of 34 years &#40;range&#58; from 23 to 49 years&#41; and a mean spherical equivalent of &#8722;4&#46;59<span class="elsevierStyleHsp" style=""></span>D &#40;range&#58; from &#8722;2&#46;25 to &#8722;8&#46;25<span class="elsevierStyleHsp" style=""></span>D&#41;&#44; and a FLEx group &#40;with flap&#41; comprising 32 eyes of 16 patients &#40;50&#37; females&#41; with a mean age of 31&#46;53 years &#40;range&#58; 22&#46;38&#41; and a mean spherical equivalent of &#8722;4&#46;57 D &#40;range&#58; from &#8722;1&#46;50 to &#8722;9&#46;25<span class="elsevierStyleHsp" style=""></span>D&#41;&#46; <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows the visual and refractive results of both groups in terms of safety&#44; efficacy and prediction&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0075" class="elsevierStylePara elsevierViewall">The mean percentage of curvature radius change&#44; <span class="elsevierStyleItalic">C</span>&#44; was &#8722;1&#46;77<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;72&#37; for the SMILE group and &#8722;2&#46;03<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;82&#37; for the FLEx group&#46; No statistically significant differences were found between the 2 groups &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;655&#41;&#46; <a class="elsevierStyleCrossRefs" href="#fig0005">Figs&#46; 1 and 2</a> show the ratio between the final corneal radius&#44; <span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">post</span></span> &#40;measured 3 months after surgery&#41; and the radius sculpted in the corneal stroma&#44; <span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">s</span></span>&#44; for the SMILE group and the FLEx group&#44; respectively&#46; A good correlation was found for the final adjustment in both groups&#44; as follows&#58; SMILE&#44; <span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">post</span></span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;84<span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">s</span></span><span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>1&#46;2 &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;95&#41;&#59; FLEx&#44; <span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">post</span></span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;71<span class="elsevierStyleItalic">R</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">s</span></span><span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>2&#46;3 &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;86&#41;&#46; The higher correlation for the SMILE group demonstrates better prediction in refractive results after surgery&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0080" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a> compares corneal topography presurgery and 3 months after the SMILE and FLEx treatments&#46; The maps showed that the FLEx technique causes more topographic changes in the corneal periphery than the SMILE treatment&#46; The SMILE group exhibited a statistically significant reduction in the mean corneal astigmatism &#40;1&#46;37<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;44<span class="elsevierStyleHsp" style=""></span>D presurgery&#59; 0&#46;81<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;53<span class="elsevierStyleHsp" style=""></span>D 3 months post-surgery&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;02&#41;&#44; whereas the FLEx group did not exhibit statistically significant differences &#40;1&#46;01<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;79<span class="elsevierStyleHsp" style=""></span>D presurgery&#59; 0&#46;97<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;51<span class="elsevierStyleHsp" style=""></span>D 3 months post-surgery&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;765&#41;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0085" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRefs" href="#fig0020">Figs&#46; 4 and 5</a> show the evolution of corneal aberrations after the SMILE and FLEx treatments&#44; respectively&#46; Both groups exhibited a statistically significant increase in the RMS value for total corneal aberration&#58; from 4&#46;0<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;7 to 8&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;6<span class="elsevierStyleHsp" style=""></span>&#956;m in the SMILE group &#40;<span class="elsevierStyleItalic">t</span>-test&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;00001&#41;&#44; and from 4&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;0 to 9&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;4<span class="elsevierStyleHsp" style=""></span>&#956;m in the FLEx group &#40;<span class="elsevierStyleItalic">t</span>-test&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;00001&#41;&#46; Post-surgery RMS values were slightly higher with the FLEx treatment but the difference was not statistically significant &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;097&#41;&#46; The individualized analysis of Zernike polynomials demonstrated significant increase for astigmatism&#44; coma and spherical aberration in both groups &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 for all comparisons&#41;&#46; However&#44; for the SMILE group no statistically significant differences were found in the RMS value for HOA &#40;1&#46;05<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;15 presurgery and 1&#46;41<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;84<span class="elsevierStyleHsp" style=""></span>&#956;m post-surgery&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;077&#41;&#46; The FLEx technique exhibited a significant increase in HOA after treatment &#40;1&#46;00<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;07 presurgery and 1&#46;93<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;46<span class="elsevierStyleHsp" style=""></span>&#956;m postsurgery&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;006&#41;&#46; In this case&#44; the difference between the post-surgery HOA values in the SMILE and FLEx was statistically significant &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;04&#41;&#46;</p><elsevierMultimedia ident="fig0020"></elsevierMultimedia><elsevierMultimedia ident="fig0025"></elsevierMultimedia></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Discussion</span><p id="par0090" class="elsevierStylePara elsevierViewall">The use of a flap in corneal refractive surgery has received special attention in the recent history of corneal refractive surgery&#46; Femtosecond-assisted lenticular extraction for correcting myopia can be carried out with a technique utilizing a corneal flap &#40;FLEx&#41; or without said flap &#40;SMILE&#41;&#46; This produces an excellent model for analyzing the actual influence of making a flap in refractive surgery results&#46; The recent global interest in the new and innovative generation of femtosecond laser correction has given rise to a large number of clinical studies&#46; Numerous articles<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">8&#8211;10</span></a> have demonstrated the stability of femtosecond laser in corneal refractive surgery&#46; Blum et al&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">9</span></a> published a study with 5 years follow-up of 108 eyes treated with FLEx&#46; In the results of said study&#44; 100&#37; of eyes obtained refractive results within 1&#46;0<span class="elsevierStyleHsp" style=""></span>D and 73&#37; within 0&#46;50<span class="elsevierStyleHsp" style=""></span>D&#44; without loss of visual acuity lines and a mean regression of 0&#46;07<span class="elsevierStyleHsp" style=""></span>D&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">Ivarsen et al&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">10</span></a> published the results of 1574 eyes submitted to SMILE&#44; with a mean spherical equivalent of &#8722;7&#46;25<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;84<span class="elsevierStyleHsp" style=""></span>D&#44; mean post-surgery refraction of &#8722;0&#46;28<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;52<span class="elsevierStyleHsp" style=""></span>D&#44; and mean treatment error of &#8722;0&#46;15<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;50<span class="elsevierStyleHsp" style=""></span>D after 3 months follow-up&#44; 86&#37; &#40;1346 eyes&#41; exhibited corrected visual acuity without changes or improved&#46; A loss of 2 or more lines was observed in 1&#46;5&#37; of eyes&#46; The refractive results of the present FLEx and SMILE groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41; match the results mentioned above and those of other authors who demonstrated the precision and stability of lenticular extraction refractive surgery with femtosecond laser<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">11</span></a>&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">In Europe&#44; a refractive correction of &#8722;3&#46;0 to &#8722;8&#46;0<span class="elsevierStyleHsp" style=""></span>D was accepted as reference for femtosecond-assisted lenticular extraction refractive surgery&#46; However&#44; some authors<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">12</span></a> reported that the SMILE is as safe and effective for correcting slight myopia&#44; as low as 1<span class="elsevierStyleHsp" style=""></span>D&#44; comparing results with LASIK treatment for the same range&#46; On the other hand&#44; a number of experienced researchers began to research these techniques in patients with high myopia of up to &#8722;14&#46;0<span class="elsevierStyleHsp" style=""></span>D&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">The SMILE technique without a flap has demonstrated to be superior in comparison to other techniques in some aspects such as improved lacrimal film and ocular surface condition&#46; Xu and Yang<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">13</span></a> reported that while the first post-surgery parameters &#40;Schirmer test&#44; tear breakup time and McMonnies score&#41; exhibited poor results in patients who underwent the SMILE and Lasik treatments&#44; the SMILE patients recovered the presurgery baseline levels in comparison with the LASIK patients who did not recover previous baseline levels&#46; It is thought that this could be due to diminished damage caused by the SMILE technique in the density of the superficial nerve fibers of the cornea and therefore with better preservation of post-surgery corneal sensitivity&#44; which has been demonstrated with confocal microscopy&#46;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">14&#44;15</span></a></p><p id="par0110" class="elsevierStylePara elsevierViewall">On the basis of the general interest in surgeries without flaps&#44; many researchers have studied the effect of the absence of a flap in the SMILE technique as regards the improvement of the post-surgery corneal biomechanics&#46; Randleman et al&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">16</span></a> indicated that the cohesive tension of the stroma is based on the way in which the lamellar structure of the stroma remains united&#44; which diminishes from the anterior to the posterior part in the central region of the cornea&#46; On the basis of this concept&#44; Reinstein et al&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">6</span></a> utilized a mathematical model to demonstrate that the post-surgery traction resistance should be greater after the SMILE treatment when compared to Lasik and PRK because the strongest laminar layer&#44; i&#46;e&#46;&#44; the anterior layer&#44; remains intact&#46; This result means that the SMILE treatment is capable of correcting higher myopia with a better safety profile&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">Similarly&#44; in a previous article<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">7</span></a> the authors have used a mathematical model for measuring unexpected changes in corneal curvature as an indirect method for evaluating alterations in the biomechanical response of the cornea&#46; This article compares to LASIK modes&#44; i&#46;e&#46;&#44; mechanic microkeratome and the femtosecond-assisted microkeratome&#46; The mathematical model is based on the concept that the corneal curvature obtained after treatment differs from the desired presurgery treatment due to several factors related to the biomechanical response of the corneal surface after making and repositioning the flap&#46; Said biomechanical response can theoretically be evaluated by studying the variation between the nominal sculpted radius &#40;or surgical radius&#41; and the corneal radius of the eye after surgery&#46; The present study found that refractive change in the corneal curvature is lower after femtosecond-assisted LASIK surgery than after the LASIK technique with the mechanical microkeratome&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">The analysis of results utilizing said mathematical model in the 2 groups of the present study indicated that the differences between the mean values and standard deviation of the change coefficient of corneal curvature between that obtained and the desired curvature in the SMILE and FLEx groups were not statistically significant&#46; However&#44; high correlation and low standard deviation in the SMILE group indicated better prediction and more consistent results for the desired vis-&#224;-vis the obtained curvature ratio despite the fact that said differences were not significant as regards the refractive and visual results&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">In what concerns corneal optical quality&#44; both treatments produced increases in the RMS values of high order aberrations&#44; as could be expected after a refractive surgery procedure&#46; However&#44; the FLEx technique&#44; based on the flap&#44; induces higher degradation of corneal optical quality in terms of HOA in comparison with the SMILE treatment which does not require a flap&#46; These results are consistent with previous studies on the optical aberrations induced by the flap after refractive surgery&#46;<a class="elsevierStyleCrossRefs" href="#bib0175"><span class="elsevierStyleSup">17&#44;18</span></a></p><p id="par0130" class="elsevierStylePara elsevierViewall">In conclusion&#44; in accordance with the model described in this paper&#44; the mean refractive change in corneal curvature related to the biomechanical response of the corneal surface after cutting and extracting the lenticule was similar in both surgical modes&#44; with and without a flap&#44; i&#46;e&#46;&#44; the FLEx and SMILE techniques&#46; However&#44; the FLEx procedure&#44; which requires making a flap&#44; exhibited a tendency which&#44; despite not being significant&#44; indicated high degradation of corneal optical quality vis-&#224;-vis the induction of HOA&#46; This finding points to a tendency toward a better prediction in surgeries that do not require a flap even though refractive or visual differences were not observed between the 2 groups of this study&#46; Accordingly&#44; the influence of the flap seems to have little relevance for the refractive and aberrometric results of femtosecond-assisted lenticular extraction according to the results of the study&#46; However&#44; the findings indirectly indicate that the SMILE&#44; flap-free surgery is biomechanically more consistent&#46; The authors consider that more studies are needed to assess other potential advantages of the results obtained with the current corneal refractive surgery without flaps&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Conflict of interests</span><p id="par0135" class="elsevierStylePara elsevierViewall">The authors state that there is no conflict of interest and that they have no interest in the property of the materials mentioned in the present article&#46;</p></span></span>"
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    "fechaRecibido" => "2016-06-09"
    "fechaAceptado" => "2016-10-08"
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            0 => "Optical quality"
            1 => "Corneal refractive surgery"
            2 => "Small incision lenticule extraction"
            3 => "Femtosecond lenticule extraction"
            4 => "Corneal flap"
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            0 => "Calidad &#243;ptica"
            1 => "Cirug&#237;a refractiva corneal"
            2 => "Extracci&#243;n lenticular de peque&#241;a incisi&#243;n"
            3 => "Extracci&#243;n lenticular con l&#225;ser femtosegundo"
            4 => "Flap corneal"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To investigate the influence of creating a flap on the postoperative optical quality of the cornea in terms of predicted corneal curvature and Seidel aberrations after 2 modalities of femtosecond assisted corneal lenticule extraction laser for the correction of myopia and myopic astigmatism&#58; the flapless procedure small incision lenticular extraction &#40;SMILE&#41; and the flap-based femtosecond lenticular extraction &#40;FLEx&#41;&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The study is a prospective consecutive non-randomized comparative interventional case series including 64 eyes with myopic or myopic astigmatism refractive errors&#46; Patients were divided into 2 groups matched for age&#44; sex and myopia&#46; One group underwent SMILE treatment and the other underwent FLEx treatment&#46; Seidel aberrations root-mean-square values were obtained with a 10<span class="elsevierStyleHsp" style=""></span>mm aperture using the ATLAS 9000 topographer before surgery and 3 months after surgery&#46; The relationship between the post-surgical corneal radius and the predicted sculpted radius were analyzed in each group&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The mean percentage change in the curvature radius was &#8722;2&#46;03&#37; in the FLEx group and &#8722;1&#46;77&#37; in the SMILE group &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;655&#41;&#46; The higher correlation for the SMILE group demonstrates a better predictability after the surgery&#46; As regards corneal aberrations&#44; the FLEx treatment showed a greater increase of higher order aberrations than SMILE treatment &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;04&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The mean refractive change in corneal curvature&#44; which is indirectly related to the biomechanical response of the corneal surface after the lenticule cut and extraction&#44; was similar after both treatments&#46; However&#44; the flap based FLEx procedure showed a greater degradation of the corneal optical quality in terms of induction of higher order aberrations&#46;</p></span>"
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      "es" => array:3 [
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Investigar la influencia de la creaci&#243;n de un flap corneal en la calidad &#243;ptica posquir&#250;rgica en t&#233;rminos de predicci&#243;n de la curvatura corneal y las aberraciones de Seidel tras 2 modalidades de extracci&#243;n lenticular corneal asistidas por l&#225;ser de femtosegundo para la correcci&#243;n de miop&#237;a y astigmatismo mi&#243;pico&#58; la t&#233;cnica de extracci&#243;n lenticular de peque&#241;a incisi&#243;n sin flap &#40;SMILE&#41; y la extracci&#243;n lenticular con femtosegundo mediante la creaci&#243;n de un flap &#40;FLEx&#41;&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Estudio prospectivo consecutivo no aleatorizado comparativo de una serie de casos previamente intervenidos&#44; incluyendo 64 ojos con un error refractivo de miop&#237;a y astigmatismo mi&#243;pico&#46; Los pacientes fueron divididos en 2 grupos en funci&#243;n de la edad&#44; sexo y miop&#237;a&#58; un grupo tratado con SMILE y otro tratado con FLEx&#46; Los valores de las aberraciones de Seidel <span class="elsevierStyleItalic">root-mean-square</span> fueron obtenidos en la visita preoperatoria y 3<span class="elsevierStyleHsp" style=""></span>meses despu&#233;s de la cirug&#237;a con una apertura de 10<span class="elsevierStyleHsp" style=""></span>mm usando el top&#243;grafo ATLAS 9000&#46; La relaci&#243;n entre el radio corneal posquir&#250;rgico real y el radio pretendido fue analizada para cada uno de los grupos&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">El porcentaje medio de cambio en la curvatura corneal fue de &#8722;2&#44;03&#37; en el grupo FLEx y de &#8722;1&#44;77&#37; en el grupo SMILE &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;655&#41;&#46; La elevada correlaci&#243;n en el grupo SMILE muestra una predicci&#243;n mejor despu&#233;s de la cirug&#237;a&#46; Respecto a las aberraciones corneales&#44; el tratamiento FLEx mostr&#243; un mayor incremento de las aberraciones de alto orden que el tratamiento SMILE &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;04&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">El cambio refractivo medio en la curvatura corneal&#44; indirectamente relacionado con la respuesta biomec&#225;nica de la superficie corneal tras el corte y extracci&#243;n del lent&#237;culo&#44; fue similar despu&#233;s de ambos tratamientos&#46; Sin embargo&#44; la t&#233;cnica FLEx basada en la creaci&#243;n del flap mostr&#243; una mayor degradaci&#243;n en la calidad &#243;ptica corneal respecto a la inducci&#243;n de aberraciones de alto orden&#46;</p></span>"
        "secciones" => array:4 [
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            "identificador" => "abst0025"
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          1 => array:2 [
            "identificador" => "abst0030"
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          3 => array:2 [
            "identificador" => "abst0040"
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    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Ali&#243; JL&#44; el Bahrawy M&#44; Angelov A&#44; Ortiz D&#44; Y&#233;bana P&#46; Influencia del flap en los resultados en la cirug&#237;a refractiva corneal con l&#225;ser de femtosegundo&#58; SMILE vs&#46; FLEx&#46; Arch Soc Esp Oftalmol&#46; 2017&#59;92&#58;218&#8211;224&#46;</p>"
      ]
    ]
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          "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Corneal topography maps of an eye prior to surgery &#40;left&#41; and 3 months after surgery &#40;right&#41; with the SMILE treatment &#40;above&#41; and FLEx &#40;below&#41;&#46; G</p>"
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                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="center" valign="top" scope="col" style="border-bottom: 2px solid black">SMILE &#37;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleItalic">Safety</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>20&#47;20 or better&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">93&#46;75&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">87&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>20&#47;25 or better&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>20&#47;40 or better&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleItalic">Efficacy</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Without loss of lines&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">96&#46;87&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">81&#46;25&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Loss of over 2 lines&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Gain of lines&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">18&#46;75 &#40;1 line&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">12&#46;50 &#40;1&#8211;2 lines&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleItalic">Results</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>&#37; of cases &#177;0&#46;5<span class="elsevierStyleHsp" style=""></span>D&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">71&#46;87&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">84&#46;43&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>&#37; of cases &#177;1&#46;0<span class="elsevierStyleHsp" style=""></span>D&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">90&#46;62&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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    "bibliografia" => array:2 [
      "titulo" => "References"
      "seccion" => array:1 [
        0 => array:2 [
          "identificador" => "bibs0005"
          "bibliografiaReferencia" => array:18 [
            0 => array:3 [
              "identificador" => "bib0095"
              "etiqueta" => "1"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Picosecond laser in situ keratomileusis with a 1053-nm Nd&#58;YLF laser"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:5 [
                            0 => "M&#46; Ito"
                            1 => "A&#46;J&#46; Quantock"
                            2 => "S&#46; Malhan"
                            3 => "D&#46;J&#46; Schanzlin"
                            4 => "R&#46;R&#46; Krueger"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
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                        "link" => array:1 [
                          0 => array:2 [
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                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            1 => array:3 [
              "identificador" => "bib0100"
              "etiqueta" => "2"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia&#58; six-month results"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "W&#46; Sekundo"
                            1 => "K&#46; Kunert"
                            2 => "C&#46; Russmann"
                            3 => "A&#46; Gille"
                            4 => "W&#46; Bissmann"
                            5 => "G&#46; Stobrawa"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1016/j.jcrs.2008.05.033"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Cataract Refract Surg"
                        "fecha" => "2008"
                        "volumen" => "34"
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                        "link" => array:1 [
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                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18721712"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            2 => array:3 [
              "identificador" => "bib0105"
              "etiqueta" => "3"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Results of small incision lenticule extraction&#58; all-in-one femtosecond laser refractive surgery"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "R&#46; Shah"
                            1 => "S&#46; Shah"
                            2 => "S&#46; Sengupta"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1016/j.jcrs.2010.07.033"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Cataract Refract Surg"
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                        "volumen" => "37"
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                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21183108"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            3 => array:3 [
              "identificador" => "bib0110"
              "etiqueta" => "4"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Accuracy and reproducibility of cap thickness in small incision lenticule extraction"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "D&#46;Z&#46; Reinstein"
                            1 => "T&#46;J&#46; Archer"
                            2 => "M&#46; Gobbe"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.3928/1081597X-20131023-02"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Refract Surg"
                        "fecha" => "2013"
                        "volumen" => "29"
                        "paginaInicial" => "810"
                        "paginaFinal" => "815"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/24168787"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            4 => array:3 [
              "identificador" => "bib0115"
              "etiqueta" => "5"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Comparison of corneal sensitivity between FS-Lasik and femtosecond lenticule extraction &#40;ReLEx flex&#41; or small-incision lenticule extraction &#40;ReLEx smile&#41; for myopic eyes"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:2 [
                            0 => "S&#46; Wei"
                            1 => "Y&#46; Wang"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1007/s00417-013-2272-0"
                      "Revista" => array:6 [
                        "tituloSerie" => "Graefes Arch Clin Exp Ophthalmol"
                        "fecha" => "2013"
                        "volumen" => "251"
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                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/23389552"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            5 => array:3 [
              "identificador" => "bib0120"
              "etiqueta" => "6"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Mathematical model to compare the relative tensile strength of the cornea after PRK&#44; Lasik&#44; and small incision lenticule extraction"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "D&#46;Z&#46; Reinstein"
                            1 => "T&#46;J&#46; Archer"
                            2 => "J&#46;B&#46; Randleman"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.3928/1081597X-20130617-03"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Refract Surg"
                        "fecha" => "2013"
                        "volumen" => "29"
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                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/23820227"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            6 => array:3 [
              "identificador" => "bib0125"
              "etiqueta" => "7"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Measurement of corneal curvature change after mechanical laser in situ keratomileusis flap creation and femtosecond laser flap creation"
                      "autores" => array:1 [
                        0 => array:2 [
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