Outcomes Of Small Incision Lenticule Extraction Research Articles

Optimizing Refractive Outcomes of SMILE: Artificial Intelligence versus Conventional State-of-the-Art Nomograms

Purpose AI (artificial intelligence)-based methodologies have become established tools for researchers and physicians in the entire field of ophthalmology. However, the potential of AI to optimize the refractive outcome of keratorefractive surgery by means of machine learning (ML)-based nomograms has not been exhausted yet. In this study, we wanted to comprehensively compare state-of-the-art conventional nomograms for Small-Incision-Lenticule-Extraction (SMILE) with a novel ML-based nomogram regarding both their spherical and astigmatic predictability. Methods A total of 1,342 eyes were analyzed for creation of three different nomograms based on a linear model (LM), a generalized additive mixed model (GAMM) and an artificial-neuronal-network (ANN), respectively. A total of 16 patient- and treatment-related features were included. Each model was trained by 895 eyes and validated by the remaining 447 eyes. Predictability was assessed by the difference between attempted and achieved change in spherical equivalent (SE) and the difference between target induced astigmatism (TIA) and surgically induced astigmatism (SIA). The root mean squared error (RMSE) of each model was computed as a measure of overall model performance. Results The RMSE of LM, GAMM and ANN were 0.355, 0.348 and 0.367 for the prediction of SE and 0.279, 0.278 and 0.290 for the astigmatic correction, respectively. By applying the created models, the theoretical yield of eyes within ±0.50 D of SE from target refraction improved from 82 to 83% (LM), 84% (GAMM) and 83% (ANN), respectively. Astigmatic outcomes showed an improvement of eyes within ±0.50 D from TIA from 90 to 93% (LM), 93% (GAMM) and 92% (ANN), respectively. Subjective manifest refraction was the single most influential covariate in all models. Conclusion Machine learning endorsed the validity of state-of-the-art linear and non-linear SMILE nomograms. However, improving the accuracy of subjective manifest refraction seems warranted for optimizing ±0.50 D SE predictability beyond an apparent methodological 90% limit.

Refractive and Visual Outcomes of SMILE for Compound Myopic Astigmatism With the VISUMAX 800

To report the first refractive and visual outcomes of small incision lenticule extraction (SMILE) using the VISUMAX 800 femtosecond laser (Carl Zeiss Meditec AG). This was a retrospective analysis of consecutive eyes treated by SMILE using the VISUMAX 800 femtosecond laser at London Vision Clinic, EuroEyes Group, London, United Kingdom. Inclusion criteria were patients aged younger than 45 years, a corrected distance visual acuity (CDVA) of 20/20 or better, and the 3-month postoperative timepoint data being available for analysis. Standard outcomes analysis and vector analysis by the Alpins method were performed. During the study period, 128 eyes of 66 consecutive patients were treated. Three-month data were available for 118 eyes (92%), and 10 eyes (8%) were lost to follow-up. The mean attempted spherical equivalent refraction (SEQ) was -4.65 ± 1.91 diopters (D) (range: -1.90 to -10.05 D) and the mean cylinder was -0.98 ± 0.78 D (range: 0.00 to -4.00 D). The mean age was 30 ± 5 years (range: 20 to 43 years), with 54% women and 46% men. Postoperative SEQ was within ±0.50 D in 86% and ±1.00 D in 100% of eyes. Uncorrected distance visual acuity was 20/20 or better in 91% of eyes. One line of CDVA was lost in 8% of eyes, and no eyes lost two or more lines. There was a small but statistically significant increase in contrast sensitivity at 3, 6, 12, and 18 cpd. Early outcomes data for SMILE with the second generation VISUMAX 800 femtosecond laser demonstrated an effective and safe option equivalent to published first generation VisuMax outcomes for the treatment myopia and astigmatism. [J Refract Surg. 2023;39(5):294-301.].

Prediction of Early Visual Outcome of Small-Incision Lenticule Extraction (SMILE) Based on Deep Learning.

Deep learning (DL) has been widely used to estimate clinical images. The objective of this project was to create DL models to predict the early postoperative visual acuity after small-incision lenticule extraction (SMILE) surgery. We enrolled three independent patient cohorts (a retrospective cohort and two prospective SMILE cohorts) who underwent the SMILE refractive correction procedure at two different refractive surgery centers from July to September 2022. The medical records and surgical videos were collected for further analysis. Based on the uncorrected visual acuity (UCVA) at 24h postsurgery, the eyes were divided into two groups: those showing good recovery and those showing poor recovery. We then trained a DL model (Resnet50) to predict eyes with early postoperative visual acuity of patients in the retrospective cohort who had undergone SMILE surgery from surgical videos and subsequently validated the model's performance in the two prospective cohorts. Finally, Gradient-weighted Class Activation Mapping (Grad-CAM) was performed for interpretation of the model. Among the 318 eyes (159 patients) enrolled in the study, 10,176 good quality femtosecond laser scanning images were obtained from the surgical videos. We observed that the developed DL model achieved a high accuracy of 96% for image prediction. The area under the curve (AUC) value of the DL model in the retrospective cohort was 0.962 and 0.998 in the training and validation datasets, respectively. The AUC values in two prospective cohorts were 0.959 and 0.936. At the video level, the trained machine learning (ML) model (XGBoost) also accurately distinguished patients with good or poor recovery. The AUC value of the ML model was 0.998 and 0.889 in the retrospective cohort (training and test datasets, respectively) and 1.000 and 0.984 in the two prospective cohorts. We also trained a DL model which can accurately distinguish suction loss (100%), black spots (85%), and opaque bubble layer (96%). The Grad-CAM heatmap indicated that our models can recognize the area of scanning and precisely identify intraoperative complications. Our findings suggest that artificial intelligence (DL and ML model) can accurately predict the early postoperative visual acuity and intraoperative complications after SMILE surgery just using surgical videos or images, which may display a great importance for artificial intelligence in application of refractive surgeries.

Clinical outcomes and higher order aberrations of wavefront-guided LASIK versus SMILE for correction of myopia: A systemic review and meta-analysis.

To systematically evaluate the clinical effect of wavefront-guided laser in situ keratomileusis (WFG-LASIK) and small incision lenticule extraction (SMILE) in terms of refractive errors and high-order aberrations. A systematic literature search of PubMed, EMBASE, the Cochrane Library, Web of Science and China National Knowledge Internet was performed to identify studies evaluating the clinical outcomes of SMILE and WFG-LASIK ended in May 2022. Meta-analyses were performed according to the PRISMA guidelines. The risk of bias of the RCTs was evaluated using the Cochrane Handbook criteria, and the quality of the non-randomised controlled studies was assessed using the Newcastle-Ottawa Scale. In total, 1385 eyes (SMILE group, 750 eyes; WFG-LASIK group, 635 eyes) from 12 studies were included. The meta-analysis demonstrated that spherical aberration was smaller in the SMILE group than in the WFG-LASIK group (standardised mean difference [SMD]: -0.34, 95% confidence interval [CI]: -0.47, -0.22; p< 0.00001), and that the postoperative values of vertical coma (SMD: 0.83; 95% CI: 0.63, 1.03; p< 0.00001) and trefoil (SMD: 0.37; 95% CI: 0.02, 0.72; p=0.04) were higher in the SMILE group compared to the WFG LASIK group. There were no significant differences in the clinical outcomes and the values of induced total higher order aberrations between the WFG-LASIK and SMILE groups (SMD: 0.05; 95% CI: -0.09, 0.19; p=0.47). Both SMILE and WFG-LASIK were found to be safe, effective, and predictable. SMILE may induce more vertical coma and trefoil, whereas WFG LASIK may induce more spherical aberrations, but no significant differences were found in the total higher order aberrations between SMILE and WFG-LASIK.

One-Year Visual Outcomes and Corneal Higher-Order Aberration Assessment of Small-Incision Lenticule Extraction for the Treatment of Myopia and Myopic Astigmatism

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.

Long-term visual quality after small incision lenticule extraction (SMILE) and laser assisted subepithelial keratomileusis (LASEK) for low myopia

BackgroundFew studies have reported the visual outcomes of small-incision lenticule extraction (SMILE) and laser-assisted subepithelial keratomileusis (LASEK) for myopia correction. This study aims to compare the visual quality and corneal wavefront aberrations after SMILE and LASEK for low-myopia correction.MethodsIn this prospective study, we included 29 eyes of 29 patients who received SMILE and 23 eyes of 23 patients who received LASEK between June 2018 and January 2019. The following measurements were assessed: uncorrected (UDVA) and corrected (CDVA) distance visual acuity, manifest refraction, corneal wavefront aberrations, and subjective visual quality. All patients were followed up for two years.ResultsAll procedures were uneventful. An efficacy index of 1.19 ± 0.17 was established in the SMILE group and 1.23 ± 0.20 in the LASEK group. No eyes lost more than two lines of CDVA. We found that 93% (27/29) of the treated eyes in the SMILE group and 91% (21/23) in the LASEK group had spherical equivalent (SE) within ± 0.25D. The increases in the total corneal spherical aberration and the corneal front spherical aberration were lower in the SMILE group than in the LASEK group (P < 0.01). In contrast, the increases in the total corneal vertical coma and the corneal front vertical coma in the SMILE group were greater than those in the LASEK group (P < 0.01).ConclusionBoth SMILE and LASEK have good safety, stability, and patient-reported satisfaction for low myopia. SMILE induced less corneal spherical aberration but greater vertical coma than LASEK.

Visual Outcomes of Small-Incision Lenticule Extraction (SMILE) in Thin Corneas.

We aimed to find out whether thin (≤500 μm) or normal (>500 μm, control) corneal thickness would impact efficacy and safety outcomes of small-incision lenticule extraction (SMILE). We retrospectively analyzed medical records of adult patients who had undergone SMILE. A total of 57 eyes were included in the “thin corneas” group and 180 eyes in the “control” group. At one month after surgery, rates of patients with uncorrected distance visual activity (UDVA) ≥ 0.8 were significantly higher in patients from the control group compared to the “thin corneas” group (87 vs. 71%, respectively p < 0.01), though rates were comparable at 3 months (87 vs. 76%, respectively, p > 0.05). SMILE had comparable safety in patients with thin and normal corneas. Procedure result predictability was comparable between groups. Regression analysis demonstrated that cap thickness impacted posterior corneal biomechanics, and the volume of removed tissue had a higher influence in patients with thin corneas. Moreover, an increase in cap thickness was associated with better final BCVA. Further study is needed for the evaluation of the impact of thin corneas on SMILE outcomes and planning. Our study also indicates that patients with thin corneas might require a different approach to nomogram calculation.

Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia With Astigmatism.

To report the outcomes of small incision lenticule extraction (SMILE) for high myopia between -9.00 and -14.00 diopters (D). This was a prospective study of SMILE for high myopia using the VisuMax femtosecond laser (Carl Zeiss Meditec). Inclusion criteria were attempted spherical equivalent refraction (SEQ) between -9.00 and -14.00 D, cylinder up to 7.00 D, corrected distance visual acuity (CDVA) of 20/40 or better, age 21 years or older, and suitable for SMILE. The sub-lenticule thickness was 220 µm or greater, and the total uncut stromal thickness was 300 µm or greater. Patients were to be followed up for 1 year. Standard outcomes analysis was performed using 12-month data where available or 3-month data otherwise. Of 187 eyes treated, data were available at 12 months for 181 eyes (96.8%) and 3 months for 4 eyes (2.1%), and 2 eyes (1.1%) were lost to follow-up. Mean attempted SEQ was -10.55 ± 1.00 D (range: -9.00 to -12.99 D). Mean cylinder was -1.19 ± 0.83 D (range: 0.00 to -4.00 D). Preoperative CDVA was 20/20 or better in 73% of eyes. Postoperative uncorrected distance visual acuity was 20/20 or better in 57% and 20/25 or better in 82% of eyes. Mean SEQ relative to target was -0.22 ± 0.48 D (range: -1.63 to +1.38 D), 66% ± 0.50 D and 93% ±1.00 D. Mean SEQ 12-month change was -0.08 ± 0.34 D (range: -1.75 to +0.88 D). There was loss of one line of CDVA in 4% of eyes, and no eyes lost two or more lines. Contrast sensitivity was unchanged. Patient satisfaction was 8 or more out of 10 in 94% and 6 or more in 99% of patients. Outcomes of SMILE for myopia greater than -9.00 D at 3 to 12 months showed excellent efficacy, safety, stability, and predictability, with high patient satisfaction. [J Refract Surg. 2022;38(5):262-271.].

Evaluation of Wide Corneal Epithelial Remodeling after Small Incision Lenticule Extraction (SMILE) with Wide-Field Optical Coherence Tomography.

Purpose This study aims to assess the corneal epithelial remodeling within a 9 mm diameter zone induced by small incision lenticule extraction (SMILE) and evaluate its relationship with the refractive outcomes. Methods A total of 64 eyes of 64 patients were included. Wide-field optical coherence tomography (OCT) was used to measure the epithelial thickness (ET) across a 9 mm diameter area, preoperatively, and after one day, one week, one month, three months, and six months postoperatively. The ET changes were compared among the different time points and analyzed zones. Results The ET increases from one week to three months and stabilized from three months to six months. Compared to the preoperative values, the mean ET changes at six months in central (2 mm), paracentral (2–5 mm), mid-peripheral (5–7 mm), and peripheral (7–9 mm) zones were 4.37, 4.36, 1.61, and −1.59 μm, respectively. The correlation between the epithelial thickening and the amount of myopia correction was positive in central (P = 0.001) and paracentral zones (P < 0.001) and negative in peripheral zone (P = 0.006). The intended diameter of the optical zone was negatively related to epithelial hyperplasia in the central (P = 0.020) and paracentral zone (P = 0.006), and the correlation was positive in the mid-peripheral zone (P = 0.001). The epithelial thickening of central zone (P = 0.012) and the difference of mean ET between central and paracentral zone (P = 0.020) were negatively related to the spherical equivalent at six months. Conclusion An asymmetric lenticule-like pattern of epithelial remodeling occurred in 9 mm diameter cornea at six months after myopic SMILE. The epithelial remodeling may affect the refractive outcomes of SMILE.

Vector analysis of moderate to high myopic astigmatism after small-incision lenticule extraction (SMILE): 12-month follow-up.

To evaluate the refractive outcomes of small-incision lenticule extraction (SMILE) surgery in moderate to high myopic astigmatism. Prospective interventional case series. This study evaluated 111 eyes of 68 patients treated with femtosecond SMILE surgery for the correction of myopia and astigmatism. Inclusion criteria were myopia of - 0.5 D or more and astigmatism between - 1.0 D and -5.0 D. Refractive and visual measurements were obtained preoperatively, 1 and 12 month(s) postoperatively. Vector analysis was used to study the astigmatic outcomes at 12-month follow-up. Comparison of results in two groups of patients with astigmatism below and over 3.00 D was performed. The preoperative mean spherical equivalent was -5.48 ± 2.17 D (range - 1.75 to - 10.00 D) and the mean cylinder was -2.02 ± 1.09 D (range - 1.00 to - 5.00 D). The mean postoperative cylinder value was -0.60 ± 0.52 D at 12-month visit. The 12-month safety and efficacy indices were 0.98 ± 0.07 and 0.97 ± 0.12, respectively. The high astigmatism group showed significantly lower safety and efficacy indices. The postoperative residual astigmatism was 0.5 D or less in 73% of the eyes. Higher amount of residual astigmatism was observed in the high astigmatism group. The angle of error was ± 5 degrees in 49% and ± 15 degrees in 87% of the eyes. SMILE surgery is effective and safe method for correcting myopic astigmatism. Vector analysis indicated a tendency for the under correction of astigmatism in subjects with high astigmatism.

Post-operative outcomes of small-incision lenticule extraction in patients with moderate to high astigmatism.

Purpose:To evaluate the visual outcomes of patients who underwent small-incision lenticule extraction (SMILE) for the treatment of myopic astigmatism with high cylinders (>2.5 diopters, D).Methods:Forty-two eyes of myopic astigmatism with a spherical error of magnitude between − 0.5 and − 6.0 Ds, cylindrical error of − 2.5 to − 4.5 Dcyl were included in the retrospective study. All patients were tested preoperatively and on days 1, 10, and 30 for uncorrected distance visual acuity, manifest refraction, and corrected distance visual acuity. Additional preoperative assessments were done including measurement of corneal thickness, corneal topography, and examination for ocular surface disease. All procedures were performed by a single experienced surgeon. VisuMax laser system (Carl Zeiss Meditec AG, Jena, Germany) was utilized for all the corrective refractive procedures.Results:Forty-two eyes were included. The logarithm of the minimum angle of resolution Uncorrected distance visual acuity (UDVA) was 1 ± 0.25 preoperatively and 0.00 ± 0.00 on postoperative day 30. There was no loss of corrected distance visual acuity (CDVA) lines.Conclusion:SMILE is a successful procedure in the treatment of both myopic spherical and cylindrical refractive errors including high cylindrical errors >-3 to − 4.5 Dcyl.

Impact of extreme (flat and steep) keratometry on the safety and efficacy of small incision lenticule extraction (SMILE)

Little is known about the connection between preoperative keratometry and postoperative results of myopic small-incision lenticule extraction (SMILE). To determine the influence of extreme (flat and steep) corneal keratometry on the safety and efficacy of SMILE, the databases of the Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany, and SMILE Eyes Linz, Austria, were screened for patients with steep and flat keratometry who had undergone SMILE. In this cross-sectional matched comparative cohort study, eyes with markedly flat (< 42.0 diopters; D) or steep (≥ 47.0D) preoperative corneal keratometry were matched to a cohort of eyes with regular keratometry (42.0–46.9D) by preoperative manifest refractive spherical equivalent and cylinder, age, corrected distance visual acuity and surgical SMILE parameters. The standardized graphs and terms for refractive surgery results were applied to compare the three groups. Changes in higher order aberrations (HOAs) were evaluated on Scheimpflug imaging. In total, 63 eyes (21 each) of 54 patients with a mean refractive spherical equivalent of − 5.21 ± 1.59 D were followed up for a mean of 9.2 ± 6.1 (minimum ≥ 3) months. Mean baseline keratometry was 41.3 ± 0.7D (flat), 45.5 ± 1.0D (regular) and 47.7 ± 0.6D (steep) (p < 0.0001). Compared to the regular group, the flat and the steep cornea group resulted in a non-inferior percentage of eyes within ± 0.50 D of target refraction (p = 0.20), uncorrected distance visual acuity (p = 0.95) and corrected distance visual acuity (p = 0.20). Flat corneas however experienced a stronger induction of spherical aberration (SA) compared to the steep group (p = 0.0005). In conclusion, non-inferior outcomes of SMILE can also be expected in eyes with steep (≥ 47D) or flat (< 42D) preoperative keratometry, while SMILE however induces more SA in eyes with a flat keratometry.

Influence of age on small incision lenticule extraction outcomes

PurposeTo evaluate the influence of patient’s age at the time of surgery on small incision lenticule extraction (SMILE) refractive outcomes.MethodsThis is a retrospective, consecutive, comparative study. We compared the refractive...

Correction de l’astigmatisme myopique par ablation d’un lenticule réfractif intracornéen (SMILE)

To study the efficacy, stability, safety and predictability of small incision lenticule extraction (SMILE) at 1 day and 3 months postoperatively for moderate and high myopic astigmatism. To describe a simple and convenient method for detection and manual compensation of cyclotorsion during the procedure. In this retrospective study, a total of 164 eyes from 114 patients over 20 years of age with at least 1.5 diopters (D) of myopic astigmatism were treated by SMILE. Any cyclotorsion was manually compensated by gently rotating the cone to align the horizontal marks on the cornea to the 0° to 180° axis of the reticule after activating the suction. The mean preoperative spherical equivalent (SE) was -5.3±2.01 D, and the mean cylinder was -2.01±0.67 D. Three months after surgery, a total of 87% of eyes were within±0.50 D of attempted post-operative SE, and 98% of eyes were within±1.00 D. Overall, the predictability of cylinder correction was excellent, with 96.3% of eyes within±1.00 D of attempted post-operative cylinder. The mean postoperative cylinder at three months was -0.3±0.39 D. We noted a slight undercorrection with treatment of high cylinder. However, 82% of eyes achieved postoperative refractive astigmatism less than 0.5 D. 91% of eyes achieved uncorrected distance visual acuity (UDVA) equal to or better than 8/10. 22% of eyes gained one line of visual acuity. SMILE is a predictable and safe technique for the surgical correction of astigmatism. Manual compensation may be an effective approach to improve astigmatic outcomes of SMILE, especially in moderate and high astigmatism.

Long-term Vector Outcomes of SMILE in Correcting Moderate to High With-the-Rule Astigmatism Under Astigmatism Axis Marked Condition.

To evaluate the vector outcomes of small incision lenticule extraction (SMILE) in correcting moderate to high myopic astigmatism under astigmatic axis marked condition. In a prospective, longitudinal, interventional study, 71 eyes (71 patients) that had with-the-rule preoperative cylinder refraction exceeding 1.50 diopters (D) were corrected with the VisuMax femtosecond laser (Carl Zeiss Meditec AG) at Zhongshan Ophthalmic Center. Refractive outcomes and astigmatic vector were evaluated preoperatively and at 1, 3, 6, and 30 months postoperatively. At 30 months postoperatively, the efficacy and safety indexes were 1.04 ± 0.18 and 1.15 ± 0.17, respectively. The magnitude of the surgically induced astigmatism (SIA) (2.13 ± 0.71 D at 1 month [P1m-pre = .018], 2.12 ± 0.72 D at 3 months [P3m-pre = .006], 2.13 ± 0.69 D at 6 months [P6m-pre = .010], and 2.19 ± 0.72 D at 30 months [P30m-pre < .001]) was slightly higher than that of the target induced astigmatism (TIA) (2.07 ± 0.69 D). Only the y-coordinate of the SIA vector had a significant overcorrection compared to that of the TIA vector (P1m-pre = .033, P3m-pre = .011, P6m-pre = .012, P30m-pre < .001). The corrected index (CI = |SIA|/|TIA|) varied from 1.03 ± 0.07 at 1 month to 1.06 ± 0.10 at 30 months, which was higher when correcting moderate astigmatism than when correcting high astigmatism (P = .041) at 30 months postoperatively. SMILE had long-term safety, efficacy, predictability, and stability when correcting moderate to high myopic astigmatism under astigmatism axis marked condition. Meanwhile, a cylinder overcorrection was observed due to the overcorrection of y-coordinate astigmatic power, which implied that the vector adjustment of the cylinder refraction nomogram should be considered. [J Refract Surg. 2020;36(9):585-591.].

Comparison of clinical outcomes between vector planning and manifest refraction planning in SMILE for myopic astigmatism.

To compare clinical outcomes of small-incision lenticule extraction (SMILE) between manifest refraction (MR) and vector planning for myopic astigmatism with high ocular residual astigmatism (ORA). Yonsei University College of Medicine and Eyereum Eye Clinic, Seoul, South Korea. Prospective, randomized, comparative case series. Patients with myopic astigmatism and ORA of 0.75 diopters (D) or greater were randomized into the MR or vector planning group and underwent SMILE without applying any nomogram for cylinder correction. Visual acuity, MR, corneal topography, and corneal aberration were measured preoperatively and postoperatively. Outcomes at 6 months postoperatively were compared between the groups. The study comprised 114 patients (114 eyes): 58 eyes in MR planning and 56 eyes in vector planning. The mean uncorrected and corrected distance visual acuity, safety and efficacy indices were comparable between the 2 groups. Postoperative refractive cylinder reached statistically significant differences between the groups (-0.22 ± 0.18 D and -0.14 ± 0.16 D in the MR and vector planning groups, respectively, P = .02). Postoperative corneal toricity and ORA reached statistically significant lower in the vector planning group. In myopic astigmatism with high ORA, MR and vector planning in SMILE were effective with comparable visual outcomes; vector planning showed statistically significant lower postoperative refractive and corneal astigmatism and ORA. Use of vector planning may improve refractive outcomes in SMILE cases with high ORA. However, the results may have been different had a nomogram adjustment been applied, as is often used for cylinder corrections with SMILE.

Visual outcomes after SMILE from the first-year experience at a U.S. military refractive surgery center and comparison with PRK and LASIK outcomes.

To assess the visual outcomes of small-incision lenticule extraction (SMILE) after the first year of treatments at a military refractive surgery center and compare with photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK) outcomes during the same period. Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir, VA. Retrospective study. Records of service members who underwent SMILE, PRK, or LASIK for myopia from March 2017 to February 2018 were reviewed. Preoperative and up to 6-month postoperative data were collected. Visual outcomes were compared between treatments. Of 563 treated eyes, 173 (30.7%) underwent SMILE, 304 (54.0%) PRK, and 86 (15.3%) LASIK. In comparing SMILE with PRK 1 month postoperatively, SMILE (145 eyes [87.9%]) attained uncorrected distance visual acuity (UDVA) ≥20/20 more vs PRK (214 eyes [73.8%]; P < .01). Similarly, SMILE (152 eyes [94.4%]) achieved more eyes with manifest spherical equivalent (MSE) within ±0.50 diopters (D) from intended target vs PRK (250 eyes [85.9%]; P = .01). None lost ≥1 line of corrected distance visual acuity in SMILE vs PRK (16 eyes [5.5%]; P < .01). Thereafter, there were no other significant differences except SMILE had 117 eyes (95.1%) vs PRK with 224 eyes (99.6%) achieving UDVA ≥20/20 at 3 months postoperatively (P = .01). In assessing SMILE vs LASIK, all parameters were comparable; however, 77 SMILE eyes (96.3%) had MSE within ±0.50 D from target vs 31 LASIK eyes (83.8%) at 6 months postoperatively (P = .02). The first year after SMILE treatments in a U.S. military center demonstrated early postoperative outcomes superior to PRK. SMILE seemed more predictable compared with LASIK.

Influence of Preoperative Keratometry on Refractive Outcomes for Myopia Correction With Small Incision Lenticule Extraction.

To evaluate the effect of preoperative keratometry on refractive outcomes after small incision lenticule extraction (SMILE) for myopia. This retrospective study comprised 515 consecutive eyes that had SMILE to correct myopia. Pearson correlation and linear regression were used to determine the relationship between residual spherical equivalent and preoperative keratometry. The same analyses were repeated in the quartiles with the lowest and highest preoperative myopia. Preoperatively, the mean spherical equivalent was -5.67 ± 1.87 diopters (D) (range: -1.63 to -9.75 D) and the mean keratometry was 43.10 ± 1.30 D (range: 38.90 to 47.00 D). Three months postoperatively, the mean spherical equivalent was -0.07 ± 0.18 D. After adjustment for age, sex, and preoperative spherical equivalent, greater postoperative undercorrection occurred in eyes with steeper corneas (P = .001). Each diopter of steeper keratometry resulted in 0.52% (0.03 D) more undercorrection. Correlation between the mean preoperative keratometry and residual spherical equivalent was significant in the lower preoperative myopia group (r = -0.24, P = .006), but not significant in the higher myopia group (r = -0.02, P = .809). Preoperative keratometry affects refractive outcomes after SMILE. Steeper corneas have greater undercorrection, especially in eyes with low myopia. Knowledge of the correlation between refractive outcomes of SMILE and keratometry would help in modifying current treatment algorithms. [J Refract Surg. 2020;36(6):374-379.].

Development of low laser energy levels in small-incision lenticule extraction: clinical results, black area, and ultrastructural evaluation.

To evaluate the outcomes of 4 low laser energy levels after small-incision lenticule extraction (SMILE) surgery. Zhongshan Ophthalmic Center, Guangzhou, China. Prospective randomized clinical trial. This study evaluated consecutive patients who had SMILE to correct myopia or myopia with astigmatism. Eyes were placed into groups based on the laser energy used during surgery (ie, 105 nJ, 110 nJ, 115 nJ, or 120 nJ). All patients had a thorough ophthalmic examination preoperative and at 4 timepoints over 3 months postoperatively. Black areas and surface regularity of the extracted lenticules were observed and evaluated qualitatively and quantitatively. The study comprised 124 eyes of 62 patients (40 women, 22 men), with 31 eyes in each laser energy group. The incidence of black areas was 45.16% (14 of 31 eyes), 12.90% (4 of 31 eyes), 16.13% (5 of 31 eyes), and 12.90% (4 of 31 eyes) for 105 nJ, 110 nJ, 115 nJ, and 120 nJ, respectively. The mean time for lenticule creation was the longest in the 105 nJ group (P = .015). The greatest increase in corneal thickness postoperatively occurred with 105 nJ (P < .05). Regression was highest in the 105 nJ group at 3 months (P < .01). However, corneal horizontal coma (C8) was lowest in the 105 nJ group at 1 week (P = .032). The lenticular surface in the 110 nJ group was the smoothest (P = .011). All contrast sensitivity values varied with time and recovered to preoperative levels by 1 week or 1 month. In all eyes, the uncorrected distance visual acuity and corrected distance visual acuity were good, with no statistically significant differences between the 4 energy groups. The 105 nJ group, in which the lowest energy was used, had the highest risk for black areas, serious postoperative corneal edema, and a significant healing response.

Hyperopic small-incision lenticule extraction.

Small-incision lenticule extraction (SMILE) has shown great promise in the treatment of myopia; however, the literature is less extensive in its hyperopic counterpart. The purpose of this review is to detail the recent advancements and outcomes of SMILE in the treatment of hyperopic eye disease. SMILE has demonstrated similar visual outcomes, regression rates, centration ability, safety profiles, and wound healing as hyperopic laser-assisted in situ keratomileusis (LASIK). Lenticule preservation and implantation show further promise in the correction of higher degrees of hyperopia. Based on the current literature, SMILE represents a viable surgical alternative to LASIK in the correction of hyperopia. Lenticule intrastromal keratoplasty and small-incision lenticule intrastromal keratoplasty may be able to correct severe hyperopia in patients who would not otherwise be candidates for refractive surgery.