Dataset Information

Small incision lenticule extraction (SMILE) combined with allogeneic intrastromal lenticule inlay for hyperopia with astigmatism.

ABSTRACT:

Purpose

To quantitatively evaluate outcomes after small incision lenticule extraction (SMILE) combined with allogeneic intrastromal lenticule inlay for hyperopia with astigmatism.

Methods

It'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.

Results

The 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).

Conclusions

SMILE combined with intrastromal lenticule inlay can be used to correct high hyperopia with astigmatism with good safety, efficacy and reproducibility.

SUBMITTER: Zhang J

PROVIDER: S-EPMC8460088 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:BackgroundHyperopia is a kind of refractive error in which incoming light is focused behind, instead of on, the retina wall due to insufficient accommodation by the lens. It is likely affected by ethnicity, geography, and a family history of hyperopia or accommodative esotropia and is categorized as low (≤ 2.00D), moderate (2.00-4.00 D), and high (> 4.00D). Beyond hyperopia refractive error, patients may have poor accommodative function or visual perceptual skills.ObjectiveThis study aimed to present the latest approaches to planning trifocal intraocular lens (IOL) and toric trifocal IOL implantation for residual refractive errors in young adults with high astigmatism and hyperopia and increase the patients' best visual outcome and satisfaction using Small Incision Lenticule Extraction (SMILE) after implantation.MethodsEighty eyes of 40 consecutive patients who underwent refractive lensectomy were included in this retrospective study. It included patients aged 20-45 years seeking spectacle independence with pre-operative high spherical hypermetropia of 4D or higher and astigmatism of 3D or higher. Patients' treatment status was categorized as trifocal IOL (n=40) and toric trifocal IOL (n=40).The mean patient follow-up time was six months after IOL implantation. First, we assessed visual acuity and satisfaction for both groups and then examined laser vision correction results of patients who were dissatisfied after IOL implantation (trifocal IOL group) and underwent SMILE surgery to increase satisfaction level.ResultsThere were no statistically significant differences between trifocal IOL and toric trifocal IOL for near (UNVA), intermediate (UIVA), and distance (UDVA) uncorrected visual acuity. Comparisons related to patient satisfaction six months after IOL implantation were statistically significant for using a computer and night driving. In the trifocal IOL group, compared to pre-operative values, sphere and cylinder at six months were significantly improved.ConclusionIn young adults, toric trifocal and trifocal IOL provided sufficient results in visual acuity; however, patients were dissatisfied after implantation. This study reported patient satisfaction levels, including quality of life and life without glasses by using Small Incision Lenticule Extraction (SMILE) surgery.

Project description:BackgroundThe design of cap thickness for small incision lenticule extraction (SMILE) plays a role in post-laser vision correction (post-LVC) corneal biomechanics. This study aimed to compare the corneal biomechanical characteristics following SMILE with different cap thicknesses of 110 μm, 120 μm, and 130 μm for myopia and myopic astigmatism correction.MethodsSeventy-five patients (146 eyes) who underwent SMILE with designed cap thickness of 110 μm, 120 μm, and 130 μm were recruited at the Eye Center of Beijing Tongren Hospital between August 2020 and November 2021. Visual acuity, refraction, and corneal biomechanical parameters were measured preoperatively, 1 week and 1, 3, 6 months postoperatively. One-way analysis of variances (ANOVA) with Bonferroni correction or Kruskal-Wallis test was performed to compare the parameters among different groups. Repeated-measures analysis of variance with Bonferroni correction or Friedman test was applied for comparing the parameters within different follow-up times.ResultsUncorrected distance visual acuity of 110-μm group was better only at 1-week and 1-month postoperatively (P = 0.012, 0.037). There were no significant differences in spherical equivalent, nor in Corvis biomechanical index-laser vision correction (CBI-LVC). All the parameters reached stability at 3-month postoperatively. Integrated radius (IR) and deformation amplitude ratio 2 mm (DA ratio 2 mm) in 120-μm and 130-μm groups were higher than 110-μm group at 1-month postoperatively (P = 0.019, 0.002). So was Ambrósio relational thickness (ARTh) at 6-month postoperatively (P = 0.011). Stiffness parameter at applanation A1 (SP-A1), stress-strain index (SSI), biomechanically corrected intraocular pressure (bIOP) and central corneal thickness (CCT) were highest in 130-μm group, followed by 120-μm group, then 110-μm group at 3-month (P<0.001, P = 0.030, P = 0.027, P = 0.008) and 6-month (P<0.001, P = 0.002, P = 0.0023, P = 0.001) postoperatively.ConclusionsThe corneal stiffness following SMILE was greatest with 130-μm cap, followed by 120-μm cap, then 110-μm cap. 130-μm cap might have advantages in terms of corneal biomechanics and retreatment option. The SMILE-designed protocol should be customized in practice.

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.