Search Results (22)

Small-incision lenticule extraction (SMILE) is a safe and effective procedure to correct myopia and myopic astigmatism. The corneal stromal lenticules extracted from SMILE surgery have good light transmission, mechanical properties, and biocompatibility, which are suitable for the treatment of a variety of corneal diseases and can solve the problem of donor cornea shortage. At present, no single method of preserving corneal stromal lenticules has been universally accepted as ideal, as the preservation of tissue integrity, optical transmittance, cellular viability, and the potential for long-term storage remain key challenges. Current approaches include short-term preservation methods such as the use of dehydrating agents and Optisol GS, and long-term preservation strategies such as cryopreservation, hydrogel nutrient capsules, and silicone oil. Standardized storage methods can improve the use of SMILE-derived lenticules as a substitute for donor corneal tissue in clinical settings. The reuse of corneal stromal lenticules is a highly regarded research area, especially in hyperopia, presbyopia, keratoconus, and some corneal ulcerative diseases, providing new possibilities for addressing corneal tissue shortage and improving surgical outcomes. Here, we review various preservation methods and clinical applications of SMILE-extracted lenticules, highlighting their potential in addressing corneal tissue shortages and the treatment of a variety of corneal diseases. Full article

Background/Objectives: In this study, we aimed to analyze the changes in the expression profiles of selected messenger RNAs (mRNAs) and their encoded proteins in the tears of patients undergoing photorefractive keratectomy (PRK), femtosecond-assisted laser in situ keratomileusis (FS-LASIK), and small-incision lenticule extraction (SMILE) procedures. Methods: A total of 120 patients were divided into three groups based on the laser vision correction (LVC) procedure: PRK, FS-LASIK, or SMILE. Tear samples were collected preoperatively and at 1, 7, 30, and 180 days postoperatively. The expression levels of selected messenger RNAs (mRNAs) and proteins were analyzed by using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and enzyme-linked immunosorbent assay (ELISA), respectively. Results: PRK and FS-LASIK elicited significantly stronger biological responses than SMILE. Interleukin-15 (IL-15) expression increased notably in the PRK and FS-LASIK groups, with mRNA levels reaching fold changes of 4.65 ± 0.65 and 4.99 ± 0.28, respectively, on day 1, compared with only 2.09 ± 0.23 in the SMILE group. Vascular endothelial growth factor A (VEGFA) levels were also elevated in the PRK (2.98 ± 0.23 fold change) and FS-LASIK groups (3.45 ± 1.09 fold change) on day 1, while the SMILE group showed minimal fluctuations. The protein concentration analysis based on the ELISA confirmed these trends, with IL-15 levels peaking at 54.2 ± 2.5 pg/mL in the PRK group and 52.8 ± 3.1 pg/mL in the FS-LASIK group, compared with 32.4 ± 1.9 pg/mL in the SMILE group on day 1. Similarly, VEGFA protein concentrations were the highest in the PRK (72.4 ± 4.1 pg/mL) and FS-LASIK patients (69.5 ± 3.8 pg/mL) on day 1 but remained low in the SMILE patients (45.6 ± 2.3 pg/mL). By day 180, gene expression and protein levels in all groups had stabilized, returning to near-preoperative values. Conclusions: PRK and FS-LASIK induced more pronounced molecular and protein-level changes during corneal wound healing than the less invasive SMILE procedure, indicating stronger biological responses. These findings suggest that tailored postoperative care based on the specific procedure could optimize healing and patient outcomes. However, further research with larger sample sizes and longer follow-ups is needed to confirm these observations and develop personalized treatment strategies. Full article

Descemet’s Stripping Only (DSO) is a surgical technique that utilizes the peripheral corneal endothelial cell (CEnC) migration for wound closure. Ripasudil, a Rho-associated protein kinase (ROCK) inhibitor, has shown potential in DSO treatment; however, its mechanism in promoting CEnC migration remains unclear. We observed that ripasudil-treated immortalized normal and Fuchs endothelial corneal dystrophy (FECD) cells exhibited significantly enhanced migration and wound healing, particularly effective in FECD cells. Ripasudil upregulated mRNA expression of Snail Family Transcriptional Repressor (SNAI1/2) and Vimentin (VIM) while decreasing Cadherin (CDH1), indicating endothelial-to-mesenchymal transition (EMT) activation. Ripasudil activated Rac1, driving the actin-related protein complex (ARPC2) to the leading edge, facilitating enhanced migration. Ex vivo studies on cadaveric and FECD Descemet’s membrane (DM) showed increased migration and proliferation of CEnCs after ripasudil treatment. An ex vivo DSO model demonstrated enhanced migration from the DM to the stroma with ripasudil. Coating small incision lenticule extraction (SMILE) tissues with an FNC coating mix and treating the cells in conjunction with ripasudil further improved migration and resulted in a monolayer formation, as detected by the ZO-1 junctional marker, thereby leading to the reduction in EMT. In conclusion, ripasudil effectively enhanced cellular migration, particularly in a novel ex vivo DSO model, when the stromal microenvironment was modulated. This suggests ripasudil as a promising adjuvant for DSO treatment, highlighting its potential clinical significance. Full article

Background/Objectives: To compare the epithelial thickness changes and the changes in epithelial wavefront aberrometry following spherical versus astigmatic myopic small incision lenticule extraction (SMILE). Methods: Eighty-six eyes of 86 patients who underwent SMILE were included in this retrospective study. A total of 43 eyes underwent myopic spherical correction (spherical group) and 43 eyes underwent myopic cylindrical correction (cylindrical group). The groups were matched according to the spherical equivalent of surgically corrected refraction. Subjective manifest refraction as well as high-resolution anterior segment optical coherence tomography (MS-39; CSO; Florence, Italy) were obtained preoperatively as well as 3 months postoperatively. The latter was utilized for computing epithelial wavefront aberrometry in addition to epithelial thickness mapping. Results: Epithelial thickness increased significantly in both groups after SMILE (p < 0.01). In the cylindrical group, epithelial thickening was more pronounced on the flat meridian compared to the steep meridian (p = 0.04). In both groups, epithelial wavefront aberrometry showed a significant postoperative increase in the epithelium’s spherical refractive power, causing a myopization of −0.24 ± 0.42 diopters (D) in the spherical group (p < 0.01) and −0.41 ± 0.52 D in the cylindrical group (p < 0.0001). While no significant changes in epithelial cylindrical refractive power were observed in the spherical group, a significant increase was noted in the cylindrical group from −0.21 ± 0.24 D to −0.37 ± 0.31 D (p = 0.01). In both groups, epithelial higher-order aberrations increased significantly (p < 0.001). Conclusions: Postoperative epithelial remodeling after SMILE alters lower-order (sphere and cylinder) and higher-order aberrations of the corneal epithelial wavefront and might contribute to refractive undercorrection, especially in astigmatic corrections. Epithelial wavefront aberrometry can be used to quantify the refractive effect of epithelial remodeling processes after keratorefractive surgery. Full article

Our objective was to evaluate the topographic and surgical factors of early myopic regression between laser in situ keratomileusis (LASIK) and small-incision lenticule extraction (SMILE). A retrospective case–control study was conducted, and 368 and 92 eyes were enrolled in the LASIK and SMILE groups via propensity score matching (PSM). Visual acuity, refractive status, axial length, and topographic/surgical parameters were collected. Multiple linear regression was applied to the yield coefficient and the 95% confidence interval (CI) of the parameters. The cumulative incidence of early myopic regression was higher in the LASIK group (p < 0.001). In the SMILE group, a lower central corneal thickness (CCT) thinnest value and a higher corneal cylinder associated with early myopic regression were observed; meanwhile, in the LASIK group, a lower CCT thinnest value, a higher steep corneal curvature, a larger optic zone, and a lower flap thickness related to early myopic regression were observed (all p < 0.05). In the SMILE group, a higher CCT difference correlated with early myopic regression was observed compared to the LASIK group (p = 0.030), and higher steep corneal curvature and lower cap/flap thickness (both p < 0.05) correlated with early myopic regression were observed in the LASIK group compared to the SMILE group. In conclusion, CCT differences significantly influence early myopic regression in the SMILE group; meanwhile, corneal curvature and flap thickness affect early myopic regression principally in the LASIK group. Full article

Background: In this study, the changes in corneal cap and residual stromal thickness (RST) values during a 180-day observation period after refractive lenticule extraction small incision lenticule extraction (ReLEx SMILE) were assessed. Methods: Fifty patients underwent ReLEx SMILE using the VisuMax 500 femtosecond laser, with corneal imaging conducted pre and post procedure via anterior segment optical coherence tomography (AS-OCT). Cap thickness in the center and 1.5 mm from the center in four meridians was measured at various intervals. Results: The results showed a significant decrease in cap thickness 180 days post procedure compared to earlier intervals (p < 0.05). Similarly, RST decreased gradually and significantly post procedure (p < 0.05). Notably, changes in cap thickness within the central 1.5 mm area were more dynamic than RST changes during the 6-month observation period following SMILE. Conclusions: The corneal cap thickness measured with swept-source AS-OCT within the central 1.5 mm area underwent more dynamic changes than the residual stromal thickness during the 6-month observation following SMILE. Full article

Background: This retrospective chart review compared the higher-order aberrations (HOAs) among photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), and small incision lenticule extraction (SMILE) alongside changes in spherical equivalent (SEQ) and corneal shape (Q-value). Methods: Analyzing 371 myopic eyes, including 154 LASIK, 173 PRK, and 44 SMILE cases, Pentacam imaging was utilized pre-operatively and at one-year post-operative visits. Results: All procedures resulted in 100% of patients achieving an uncorrected distance visual acuity (UDVA) of 20/40 or better, with 87% of LASIK and PRK, and 91% of SMILE patients having 20/20 or better. Significant increases in HOAs were observed across all procedures (p < 0.05), correlating positively with SEQ and Q-value changes (LASIK (0.686, p < 0.05), followed by PRK (0.4503, p < 0.05), and SMILE (0.386, p < 0.05)). Vertical coma and spherical aberration (SA) were the primary factors for heightened aberration magnitude among the procedures (p < 0.05), with the largest contribution in SMILE, which is likely attributed to the centration at the corneal apex. Notably, PRK showed insignificant changes in vertical coma (−0.197 µm ± 0.0168 to −0.192 µm ± 0.0198, p = 0.78), with an increase in oblique trefoil (p < 0.05). Conclusions: These findings underscore differences in HOAs among PRK, LASIK, and SMILE, helping to guide clinicians. Full article

Few studies have reported the differential outcomes of Small Incision Lenticule Extraction (SMILE) on myopic astigmatism. Given this, we examined the effectiveness of SMILE for up to one year, comparing with-the-rule (WTR), against-the-rule (ATR), and oblique astigmatism, conducting a retrospective review of patients who underwent correction of myopic astigmatism using the 500-kHz VisuMax femtosecond laser (Carl Zeiss Meditec) at two refractive clinics in Poland between 2016–2017. Patients were aged ≥21 with stable refractive errors between −0.5 and −10.0 diopter (D) with astigmatism up to 5D. The mean age of the 209 patients (355 eyes) available was 32 years; 58.4% were female. Of these, 247 had WTR, 62 oblique, and 46 ATR astigmatism. The mean pre-operative spherical equivalent (SE) was −5.4 ± 2.57D and the cylinder −1.7 ± 1.0D. The mean SE for WTR reduced from −5.60 ± 2.37D to −0.31 ± 0.67D at 2 months and −0.38 ± 0.70D at 12 months; the mean cylinder improved from −1.90 ± 1.10D to −0.31 ± 0.39D and −0.36 ± 0.43D, respectively. Eyes with oblique astigmatism also improved from a mean SE of −5.8 ± 3.4 D to −0.82 ± 1.50D and −0.69 ± 1.15D and a cylinder of −1.4 ± 0.73D to −0.17 ± 0.33D at 2 months and −0.1 ± 0.32D at 12. For ATR, the mean SE improved from −4.0 ± 1.8D to −0.08 ± 0.22D and −0.04 ± 0.12D; and the mean cylinder from −1.25 ± 0.53 to −0.02 ± 0.09D −0.08 ± 0.21D at 2 and 12 months, respectively. There were statistically significant improvements in SE, manifest sphere and cylinder refraction, and UDVA and CDVA scores for each cylinder type at 2 months with ATR cylinders having better outcomes. Although missing data limited interpretation at one year, differences were maintained. The magnitude of error calculations suggests that WTR was more prone to under-correction, particularly for high astigmatism (>1.5D). SMILE for myopic astigmatism reliably corrects SE, irrespective of the subtype of astigmatism. Full article

The aim of the present study is to analyze the impact of cornea virus latent infection on corneal healing after small incision lenticule extraction (SMILE) and predict the positive rate of virus latent infection in corneal stroma. A total of 279 patients who underwent SMILE were included in this study. Fluorescence quantitative PCR was used to detect virus infection in the lenticules, which were taken from the corneal stroma during SMILE. Herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), Epstein–Barr virus (EBV), and cytomegalovirus (CMV) were detected. Postoperative visual acuity, spherical equivalent, intraocular pressure, corneal curvature (Kf and Ks), corneal transparency, and corneal staining were compared between the virus-positive group and the virus-negative group. The number of corneal stromal cells and inflammatory cells, corneal nerve fiber density (CNFD), corneal nerve branch density (CNBD), corneal nerve fiber length (CNFL), corneal total branch density (CTBD), and corneal nerve fiber width (CNFW) were evaluated using an in vivo confocal microscope. Out of 240 herpes simplex virus (HSV) tested samples, 11 (4.58%) were positive, among which 5 (2.08%) were HSV-1-positive and 6 (2.50%) were HSV-2-positive. None of the 91 CMV- and EBV-tested samples were positive. There was no statistical significance in the postoperative visual acuity, spherical equivalent, intraocular pressure, Kf and Ks, corneal transparency, corneal staining, the number of corneal stromal cells and inflammatory cells, CNFD, CNBD, CNFL, CTBD, and CNFW between the virus-positive and virus-negative groups (p > 0.05). In conclusion, there is a certain proportion of latent HSV infection in the myopia population. Femtosecond lasers are less likely to activate a latent infection of HSV in the cornea. The latent infection of HSV has no significant impact on corneal healing after SMILE. Full article

The aim of this study was to explore the impact of dry eye disease (DED) on the uncorrected distance visual acuity (UDVA) and refractive status after small incision lenticule extraction (SMILE). This prospective cohort study enrolled 29 patients (DED group, 11 eyes; non-DED group, 18 eyes) who underwent SMILE in our center from July to September 2022. The examinations on DED, refractive status and UDVA were performed before surgery, and on day 7 and 20 after surgery. The results showed that on day 20 after SMILE, subjects in the non-DED group reported greater changes of ocular surface disease index value increase and tear-film breakup time reduction compared to baseline than those in the DED group (p < 0.001 and p = 0.048, respectively). Compared to preoperative status, DED patients had greater improvements of UDVA and better optometric outcomes on day 20 after surgery than non-DED subjects (p = 0.008 and 0.026, respectively). Multiple linear regression analysis showed age, contact lens daily wearing time, and tear meniscus height before surgery were of the highest value to predict UDVA on day 20 after SMILE in contact lens wearers (p = 0.006, 0.010 and 0.043, respectively). In conclusion, preoperative tear function could affect UDVA after SMILE. The impact of DED on UDVA and refraction should be taken into consideration before surgery. Full article

Small-incision lenticule extraction (SMILE) is a safe and effective surgical procedure for refractive correction. However, the nomogram from the VisuMax femtosecond laser system often overestimates the achieved lenticule thickness (LT), leading to inaccurate estimation of residual central corneal thickness in some patients. In order to improve the accuracy of predicting achieved LT, we used machine learning models to make predictions of LT and analyze the influencing factors of LT estimation in this study. We collected nine variables of 302 eyes and their LT results as input variables. The input variables included age, sex, mean K reading of anterior corneal surface, lenticule diameter, preoperative CCT, axial length, the eccentricity of the anterior corneal surface (E), diopter of spherical, and diopter of the cylinder. Multiple linear regression and several machine learning algorithms were employed in developing the models for predicting LT. According to the evaluation results, the Random Forest (RF) model achieved the highest performance in predicting the LT with an R² of 0.95 and found the importance of CCT and E in predicting LT. To validate the effectiveness of the RF model, we selected additional 50 eyes for testing. Results showed that the nomogram overestimated LT by 19.59% on average, while the RF model underestimated LT by −0.15%. In conclusion, this study can provide efficient technical support for the accurate estimation of LT in SMILE. Full article

The role of corneal biomechanics in laser vision correction (LVC) is currently being raised in the assessment of postoperative corneal ectasia risk. The aim of the paper was to evaluate the changes in corneal biomechanics after LVC procedures based on a systematic review of current studies. The results of a search of the literature in the PubMed, Science Direct, Google Scholar, and Web of Science databases were selected for final consideration according to the PRISMA 2020 flow diagram. Included in our review were 17 prospective clinical studies, with at least 6 months of follow-up time. Corneal biomechanical properties were assessed by Ocular Response Analyzer (ORA), or Corvis ST. The results of the study revealed the highest corneal biomechanics reduction after laser in situ keratomileusis (LASIK) followed by small incision lenticule extraction (SMILE) and surface procedures, such as photorefractive keratectomy (PRK) or laser-assisted sub-epithelial keratectomy (LASEK). In SMILE procedure treatment planning, the use of thicker caps preserves the corneal biomechanics. Similarly, reduction of flap thickness in LASIK surgery maintains the corneal biomechanical strength. Future prospective clinical trials with standardization of the study groups and surgical parameters are needed to confirm the results of the current review. Full article

This work aims to depth-resolved quantitatively analyze the effect of different stromal ablation amounts on the corneal biomechanical properties during small incision lenticule extraction (SMILE) using optical coherence elastography (OCE). A 4.5-MHz ultrasonic transducer was used to excite elastic waves in the corneal tissue. The OCE system combined with the antisymmetric Lamb wave model was employed to achieve a high-resolution, high-sensitivity, and depth-resolved quantitative detection of the corneal Young’s modulus. Eighteen rabbits were randomly divided into three groups; each group had six rabbits. The first and second groups underwent -3D and -6D SMILE surgeries, and the third group was the control group, respectively. Young’s modulus of the corneal cap and residual stromal bed (RSB) were both increased after SMILE, which shared the stress under intraocular pressure (IOP). Furthermore, the Young’s modulus of both the corneal cap and RSB after 3D SMILE group were significantly lower than that in the -6D group, which indicated that the increases in the post-operative corneal Young’s modulus were positively correlated with the amount of stromal ablation. The OCE system for quantitative spatial characterization of corneal biomechanical properties can provide useful information on the extent of safe ablation for SMILE procedures. Full article

We present a retrospective, single-center report of one-year visual outcomes for Small Incision Lenticule Extraction (SMILE) to treat myopia and myopic astigmatism, as well as to compare outcomes with other published literature, including results from the United States Food and Drug Administration (US FDA). A total of 405 eyes with a mean preoperative spherical equivalent of −5.54 diopters (D) underwent SMILE between April 2017 and April 2022. The outcomes measured included visual acuity, manifest refraction, vector analysis, and wavefront aberrometry at various time points, specifically pre-operative and twelve months post-operatively. Results were compared to other similar published studies of SMILE outcomes between 2012 and 2021. A total of 308 and 213 eyes were evaluated at three and twelve months, respectively. At twelve months, 79% of eyes achieved UDVA ≥ 20/20, and 99% had ≥20/40, with no patients losing ≥2 lines of vision. For accuracy, 84% of eyes were within 0.5 D of target SEQ, and 97% were within 1 D. Total corneal higher order aberrations (HOA) increased from 0.33 to 0.61 um. Significant change was found in vertical coma and spherical aberration at twelve months. SMILE remains a safe and effective treatment for myopia and myopic astigmatism. Clinical outcomes are likely to improve with increased surgeon experience and refinement of technology and nomograms. Full article

Ocular aberrations, particularly corneal higher-order aberrations (HOAs), which impair visual quality, should be minimized or corrected during any laser vision correction. We compared changes in visual outcomes, including HOAs, in patients who underwent Topography-Guided laser-assisted in situ keratomileusis (TG-LASIK) or small-incision lenticule extraction (SMILE) after propensity score matching (PSM) to reduce selection bias. Of 2749 patients who underwent SMILE or TG-LASIK for myopia, 152 eyes underwent complete ophthalmic examination preoperatively and over six months postoperatively. Visual outcomes were comparatively analyzed after PSM. As a result, 45 eyes were included in each group after PSM. There was a comparable improvement in visual acuity (VA) and refractive parameters postoperatively, with no difference between the two PSM-groups. However, 6.6% in the SMILE PSM-group lost two or more lines of Snellen VA at the six-month follow-up, while none in the TG-LASIK PSM-group did. Specifically, the SMILE PSM-group showed a significant increase in corneal HOAs, including spherical aberration, coma, and total HOAs (0.0736 ± 0.162 μm; 0.181 ± 0.233 μm; and 0.151 ± 0.178 μm, respectively), whereas TG-LASIK PSM-group did not. Furthermore, SMILE PSM-group had greater postoperative corneal HOAs than those in TG-LASIK PSM-group. Collectively, TG-LASIK induces fewer corneal HOAs even after facilitating between-group comparability using PSM analysis. TG-LASIK provides better visual quality than SMILE for myopia. Full article