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Retreatment strategies following Small Incision Lenticule Extraction (SMILE): In vivo tissue responses.

ABSTRACT: With any refractive correction, including Small Incision Lenticule Extraction (SMILE), there may be a residual refractive error that requires a retreatment. Here, we investigated the tissue responses following various retreatment procedures in a rabbit model of SMILE. All rabbits underwent a -6.00D correction with SMILE. Two weeks later, they underwent -1.00D enhancement by: (i) VisuMax Circle, followed by excimer ablation (S+C); (ii) secondary SMILE anterior to the primary procedure (S+SE); or (iii) surface ablation (S+P), and were examined for 28 days. S+P induced corneal edema and haze, and more CD11b- (23±6 cells) and TUNEL-positive (36±4 cells) cells in the central stromal superficial layers early post-operatively (p<0.001 compared to other procedures). The corneas appeared normal on day 28 after S+P, but had a lower number of keratocytes near the laser ablated plane compared to other procedures. S+SE and S+C did not induce corneal haze and resulted similar level of fibronectin. However, S+C resulted in more inflammatory (10±2 cells; p = 0.001) and apoptotic cells (25±2 cells; p<0.001) compared to S+SE (7±1 inflammatory cells and 21±3 apoptotic cells) early post-operatively. In conclusion, each SMILE retreatment method resulted in unique tissue responses. S+SE offers advantages, such as minimal inflammation and cell death, as well as maintaining a 'flap-less' surgery, over other procedures. However, depending on the degree of enhancement, the lenticule may become too thin to be extracted and the procedure becomes more difficult to perform than S+C and S+P. S+P can maintain corneal integrity by avoiding flap creation and is technically more simple to perform than the others, but the surgery needs to be supplemented with mitomycin-C in order to reduce inflammation and modulate better wound healing.

SUBMITTER: Riau AK

PROVIDER: S-EPMC5510831 | biostudies-other | 2017

REPOSITORIES: biostudies-other

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Retreatment strategies following Small Incision Lenticule Extraction (SMILE): In vivo tissue responses.

Riau Andri K AK Liu Yu-Chi YC Lim Chris H L CHL Lwin Nyein C NC Teo Ericia P EP Yam Gary H GH Tan Donald T DT Mehta Jodhbir S JS

PloS one 20170714 7

With any refractive correction, including Small Incision Lenticule Extraction (SMILE), there may be a residual refractive error that requires a retreatment. Here, we investigated the tissue responses following various retreatment procedures in a rabbit model of SMILE. All rabbits underwent a -6.00D correction with SMILE. Two weeks later, they underwent -1.00D enhancement by: (i) VisuMax Circle, followed by excimer ablation (S+C); (ii) secondary SMILE anterior to the primary procedure (S+SE); or ...[more]

PMID: 28708898

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Project description:PurposeTo quantitatively evaluate outcomes after small incision lenticule extraction (SMILE) combined with allogeneic intrastromal lenticule inlay for hyperopia with astigmatism.MethodsIt's a retrospective cohort study. Twenty-four eyes of 15 patients with more than 0.75 diopters (D) of astigmatism in hyperopic eyes were enrolled in this study. The hyperopic eye with astigmatism was first treated with SMILE to correct astigmatism; then a lenticule was extracted from a donor myopic eye and subsequently implanted into the hyperopic eye with astigmatism. Patients were examined preoperatively and 1 day, 1 week, 1,3 months and 1 year after surgery. The main outcome measures were the uncorrected and corrected distance visual acuity (UDVA and CDVA), uncorrected near visual acuity (UNVA), spherical equivalent (SE), corneal topography, anterior segment optical coherence topography (OCT) and ocular response analyzer (ORA) parameters: corneal hysteresis (CH) and corneal resistance factor (CRF). Repeated-measures analyses of variance (ANOVA) and post hoc tests were used to analyze data of different follow-up visits.ResultsThe mean preoperative cylinder was 1.95±1.04(D). The UDVA (from 0.37±0.23 to 0.09±0.09), UNVA (from 0.49±0.21 to 0.08±0.06), SE (from +7.42±3.12 to -0.75±0.79) and astigmatism (+1.95±1.04 to -0.65±0.63) postoperatively were obviously better than those before surgery. Five eyes (26.3%) gained one line of CDVA, and 3 eyes (15.8%) gained two lines of CDVA one year after surgery compared with preoperative levels. The average corneal curvature was changed from (43.19±4.37) D to (49.19±3.87) D one year after surgery. The anterior segment OCT images of corneas with lenticule inlays at each follow-up visit showed that the implanted lenticule was shaped like a crescent in the corneal stroma. The CH and CRF didn't change significantly after surgery (p = 0.189 and p = 0.107respectively).ConclusionsSMILE combined with intrastromal lenticule inlay can be used to correct high hyperopia with astigmatism with good safety, efficacy and reproducibility.

Project description:IntroductionAstigmatism correction after small-incision lenticule extraction (SMILE) surgery is affected by several factors, including ocular residual astigmatism (ORA), which accounts for the vector difference between refractive and corneal astigmatism. Previous studies revealed the relationship between ORA and astigmatism correction after laser-assisted in situ keratomileusis (LASIK). However, in SMILE surgery, no comprehensive study exploring the link between these two variables has been performed. We have therefore assessed the association between ORA and astigmatism correction after SMILE.MethodsThis was a retrospective, single-centered study. Patients with myopia or myopic astigmatism who underwent SMILE surgery using the 500-kHz Visumax laser platform and were followed up for at least 3 months were included. Patients' demographic and clinical characteristics, such as visual acuity, refractive status and corneal tomography, were recorded. ORA was calculated using Alpins Statistical System for Ophthalmic Refractive Surgery Techniques (ASSORT) Ocular Residual Astigmatism calculator.ResultsA total of 888 eyes (408 eyes from males and 480 eyes from females) from 444 patients (mean age [standard deviation] 32.4 ± 7.1 years) were included in our study. Mean (± SD) preoperative sphere and cylinder were - 5.45 ± 1.98 (range - 10.00-0.00) diopter (D) and - 0.89 ± 0.70 (range - 4.00-0.00) D, respectively. Calculated mean ORA was 0.68 ± 0.35 (range 0.07-3.53) D. Postoperative logMAR uncorrected visual acuity was 0.03 ± 0.31. Mean postoperative sphere and cylinder were - 0.10 ± 0.56 (range - 1.5 to 1.0) D and - 0.51 ± 0.37 (- 1.5 to 0.0) D, respectively. The Pearson correlation test revealed preoperative sphere, steep keratometry (steep-K) and ORA were statistically correlated with the amplitude of astigmatism correction (P < 0.001), and the generalized estimating equations analysis showed that ORA was negatively correlated with the amplitude of astigmatism correction (P < 0.001).ConclusionThe results of our study suggest that preoperative higher ORA may be associated with a lower magnitude of astigmatism correction after SMILE surgery in patients with all levels of astigmatism preoperative.Trial registrationClinicalTrials.gov: NCT05604872. Registered 3 November 2022-Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT05604872.

Project description:Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3?months post-operatively.Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21?years old) with myopia (> -3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3?months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21?years old) with myopia (> -3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3?months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye.This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice.Clinicaltrials.gov NCT01216475.

Project description:BackgroundSmall-incision lenticule extraction (SMILE) is a surgical procedure for the refractive correction of myopia and astigmatism, which has been reported as safe and effective. However, over- and under-correction still occur after SMILE. The necessity of nomograms is emphasized to achieve optimal refractive results. Ophthalmologists diagnose nomograms by analyzing the preoperative refractive data with their individual knowledge which they accumulate over years of experience. Our aim was to predict the nomograms of sphere, cylinder, and astigmatism axis for SMILE accurately by applying machine learning algorithm.MethodsWe retrospectively analyzed the data of 3,034 eyes composed of four categorical features and 28 numerical features selected from 46 features. The multiple linear regression, decision tree, AdaBoost, XGBoost, and multi-layer perceptron were employed in developing the nomogram models for sphere, cylinder, and astigmatism axis. The scores of the root-mean-square error (RMSE) and accuracy were evaluated and compared. Subsequently, the feature importance of the best models was calculated.ResultsAdaBoost achieved the highest performance with RMSE of 0.1378, 0.1166, and 5.17 for the sphere, cylinder, and astigmatism axis, respectively. The accuracies of which error below 0.25 D for the sphere and cylinder nomograms and 25° for the astigmatism axis nomograms were 0.969, 0.976, and 0.994, respectively. The feature with the highest importance was preoperative manifest refraction for all the cases of nomograms. For the sphere and cylinder nomograms, the following highly important feature was the surgeon.ConclusionsAmong the diverse machine learning algorithms, AdaBoost exhibited the highest performance in the prediction of the sphere, cylinder, and astigmatism axis nomograms for SMILE. The study proved the feasibility of applying artificial intelligence (AI) to nomograms for SMILE. Also, it may enhance the quality of the surgical result of SMILE by providing assistance in nomograms and preventing the misdiagnosis in nomograms.

Dataset Information

Retreatment strategies following Small Incision Lenticule Extraction (SMILE): In vivo tissue responses.

Publications

Retreatment strategies following Small Incision Lenticule Extraction (SMILE): In vivo tissue responses.

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