Dataset Information

Feasibility study of treatment of mixed astigmatism with small-incision lenticule extraction (SMILE) by using research software.

ABSTRACT:

Purpose

To report the preliminary experience and initial clinical results following SMILE for the treatment of mixed astigmatism.

Methods

Thirteen eyes of nine patients with a mean age of 27 ± 4.36 years were included in the series. In 8/13 eyes, myopic SMILE license and in 4/13 eyes, hyperopic SMILE license (available as part of an open/research software) was used for the treatment. The mean follow-up was 9.5 ± 8.7 (0.5-24) months, and the median follow-up was 6 months.

Setting

Nethradhama Superspeciality Eye Hospital, Bangalore, India.

Design

Exploratory study.

Results

The mean preoperative sphere, cylinder, and spherical equivalent (SE) were 1.44 ± 1.63, -2.70 ± 2.30, and -0.24 ± 1.14 D, which changed to -0.03 ± 0.30, -0.28 ± 0.48, and -0.18 ± 0.49 D, respectively, 6 months postoperatively. Furthermore, 85% (11/13) eyes were within ± 0.50 D, 92% (12/13) eyes were within ± 1.00 D, while all eyes were within ± 1.50 D of SE correction. All eyes were within ± 1.00 D of cylinder correction. In addition, 92% (12/13) eyes had UDVA better than 20/32, with 54% (7/13) eyes having UDVA 20/20 or better. Safety and efficacy indices were 1.08 and 0.92, respectively. No eyes lost more than 1 line of CDVA. The mean corneal higher order aberrations (HOA) increased from 0.111 ± 0.048 to 0.209 ± 0.056 (P < 0.001). The mean objective scatter index (OSI) did not show a significant change (pre = 0.71 ± 0.69, 6 months = 0.89 ± 0.20; P = 0.35).

Conclusion

Early experience showed that SMILE was feasible for the management of eyes with mixed astigmatism, without any intraoperative complications, unique to the procedure.

SUBMITTER: Ganesh S

PROVIDER: S-EPMC11329817 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Publications

Feasibility study of treatment of mixed astigmatism with small-incision lenticule extraction (SMILE) by using research software.

Ganesh Sri S Brar Sheetal S Bose Shilpi S Shah Mamta Lakhana ML

Indian journal of ophthalmology 20240622 7

<h4>Purpose</h4>To report the preliminary experience and initial clinical results following SMILE for the treatment of mixed astigmatism.<h4>Methods</h4>Thirteen eyes of nine patients with a mean age of 27 ± 4.36 years were included in the series. In 8/13 eyes, myopic SMILE license and in 4/13 eyes, hyperopic SMILE license (available as part of an open/research software) was used for the treatment. The mean follow-up was 9.5 ± 8.7 (0.5-24) months, and the median follow-up was 6 months.<h4>Settin ...[more]

PMID: 38905464

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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:PurposeThis study aimed to evaluate the efficacy of small-incision lenticule extraction (SMILE) in improving vision and visual quality and correcting astigmatism for the treatment of high astigmatism.MethodsEligible studies and studies comparing the efficacy of SMILE with femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) or transepithelial photorefractive keratectomy (T-PRK) for high astigmatism (≥2.00 D) were identified in PubMed, Embase, and the Cochrane Central Register of Controlled Trials, searched from their inception to 29 May 2022. The references of all searched studies were checked as supplements. The risk of bias was evaluated for each eligible study. The literature was screened according to the inclusion and exclusion criteria, and relative data were extracted. Data were extracted and analyzed by ReviewManager 5.4. The primary outcome was post-operative uncorrected distance visual acuity (UDVA). The secondary outcomes included corneal aberrations and vector parameters. The weight mean difference (WMD) and their 95% confidence intervals (95% CI) were used to assess the strength of the association.ResultsA total of six studies including 380 astigmatism eyes were involved, with 211 high-astigmatism eyes and 31 low-astigmatism eyes undergoing SMILE surgery, 94 high-astigmatism eyes undergoing FS-LASIK surgery, and 44 high-astigmatism eyes undergoing T-PRK surgery. Compared with non-SMILE, SMILE induced more astigmatism (weighted mean difference [WMD] = -0.07, 95% CI [-0.12 to -0.02], P = 0.005) and fewer sphere aberrations (WMD = -0.12, 95% CI [-0.17 to -0.08], P < 0.00001). The post-operative UDVA, sphere, spherical equivalent (SE), and higher order aberrations in different surgeries were likewise equivalent. The difference vector and index of success were significantly higher, and the surgically induced astigmatism vector, correction index, and magnitude of error were significantly lower in SMILE.ConclusionThis meta-analysis suggests that SMILE, FS-LASIK, and T-PRK show excellent efficacy, predictability, and safety for myopia. SMILE exhibited less astigmatism refraction predictability and less surgically induced spherical aberrations. There may be more under-correction in SMILE. More randomized, prospective, and large sample-sized studies are needed to confirm these conclusions in the long term.

Project description:IntroductionDeep 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.MethodsWe 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 24 h 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.ResultsAmong 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.ConclusionsOur 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.

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.

Dataset Information

Feasibility study of treatment of mixed astigmatism with small-incision lenticule extraction (SMILE) by using research software.

Purpose

Methods

Setting

Design

Results

Conclusion

Publications

Feasibility study of treatment of mixed astigmatism with small-incision lenticule extraction (SMILE) by using research software.

Similar Datasets

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