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Clinical Relevance: More than 6 million small-incision lenticule extraction (SMILE) procedures have been performed worldwide since 2011. Therefore, its long-term safety and efficacy should be investigated., Background: This study aimed to evaluate 10-year refractive outcomes, corneal stability, axial length, and wavefront aberrations in patients who underwent SMILE to correct myopia., Methods: Thirty two patients (32 eyes) who underwent SMILE-based myopic correction. Corrected distance visual acuity, uncorrected distance visual acuity, corneal stability, axial length, and wavefront aberrations were evaluated preoperatively and at 1 month and 1, 5, and 10 years postoperatively., Results: At 10 years postoperatively, the safety and efficacy indices for the patients included in this study were 1.19 ± 0.21 and 1.04 ± 0.27, respectively. For 26 (81%) and 30 eyes (94%), correction to within ±0.50 D and ±1.00 D of the target was achieved, respectively. Over the 10-year follow-up duration, a mean -0.32 ± 0.56 D regression was observed (-0.03 ± 0.06 D/year). Relative to baseline, horizontal and vertical comas significantly increased, as did the incidence of higher-order aberrations (all P  < 0.001), whereas axial length and corneal elevation remained stable during follow-up., Conclusion: These results indicate that the SMILE-based correction for myopia of up to -10 Dioptres is safe, effective, and stable, with relatively constant wavefront aberrations and corneal stability over time after treatment.

Importance: Growing evidence indicates that adverse prenatal or intrauterine environments might contribute to the development of high refractive error (RE) later in life. However, the association of maternal hypertensive disorder of pregnancy (HDP) with high RE in offspring during childhood and adolescence remains unknown., Objective: To investigate the association between maternal HDP and overall and type-specific high REs in offspring in childhood and adolescence., Design, Setting, and Participants: This nationwide population-based cohort study included live-born individuals born in Denmark from 1978 to 2018 in the Danish national health registers. Follow-up started at the date of birth and ended at the date of RE diagnosis, 18th birthday, death, emigration, or December 31, 2018, whichever came first. Data analyses were conducted from November 12, 2021, through June 30, 2022., Exposures: Maternal HDP (n = 104 952), including preeclampsia or eclampsia (n = 70 465) and hypertension (n = 34 487)., Main Outcomes and Measures: The main outcomes were the first occurrence of high RE (hyperopia, myopia, and astigmatism) in offspring. A Cox proportional hazards regression model was used to examine the association between maternal HDP and risk of high RE in offspring from birth until age 18 years, adjusting for multiple potential confounders., Results: This study included 2 537 421 live-born individuals, 51.30% of whom were male. During the follow-up of up to 18 years, 946 offspring of 104 952 mothers with HDP (0.90%) and 15 559 offspring of 2 432 469 mothers without HDP (0.64%) were diagnosed with high RE. The cumulative incidence of high RE was higher in the exposed cohort (1.12%; 95% CI, 1.05%-1.19%) than in the unexposed cohort (0.80%; 95% CI, 0.78%-0.81%) at 18 years of age (difference: 0.32%; 95% CI, 0.25%-0.40%). Offspring born to mothers with HDP had a 39% increased risk of overall high RE (hazard ratio [HR], 1.39; 95% CI, 1.31-1.49). Sibling-matched analysis revealed an increased risk of overall high RE in half siblings (HR, 1.21; 95% CI, 1.05-1.39) and full siblings (HR, 1.15; 95% CI, 0.99-1.34), but the difference was not significant for the latter. The elevated risks were observed for hypermetropia (HR, 1.41; 95% CI, 1.30-1.52), myopia (HR, 1.30; 95% CI, 1.10-1.53), and astigmatism (HR, 1.45; 95% CI, 1.22-1.71). The increased risk of high RE persisted among offspring aged 0 to 6 years (HR, 1.51, 95% CI, 1.38-1.65), 7 to 12 years (HR, 1.28; 95% CI, 1.11-1.47), and 13 to 18 years (HR, 1.16; 95% CI, 0.95-1.41), but the difference was not significant for the oldest group. When considering both timing of diagnosis and severity of maternal preeclampsia, the highest risk was observed in offspring prenatally exposed to early-onset and severe preeclampsia (HR, 2.59; 95% CI, 2.17-3.08)., Conclusions and Relevance: In this cohort study of the Danish population, maternal HDP, especially early-onset and severe preeclampsia, was associated with an increased risk of high RE in offspring during childhood and adolescence. These findings suggest that early and regular RE screening should be recommended for children of mothers with HDP.

Aims: To compare the vault performance between implantable collamer lens (ICL) V4c and Toric ICL (TICL) V4c after implantation and to investigate the affecting factors., Methods: Sixty-eight eyes from 34 patients with myopia or myopia astigmatism who underwent implantation of TICL in one eye (group A) and identically sized ICL (group B) in the contralateral eye were included. Mean follow-up time were 7.58 ± 1.63 months (range: 6-10 months). Vault was compared between the two groups and correlations between vault and age, preoperative ocular biometric measurements were analysed. Generalized estimating equation (GEE) model of postoperative vault adjusting for within-patient intereye correlations was performed., Results: The safety indices were 1.27 and 1.35, and the efficacy indices were 1.20 and 1.24 for groups A and B, respectively. Vault of TICL was significantly higher than that of ICL (554.11 ± 219.36 μm vs 449.70 ± 172.47 μm, P < 0.001). The difference between ICL/TICL size and WTW (size-WTW) and STS (size-STS), anterior chamber depth and pupil diameter (PD) were positively correlated with vault. Patient age and clear lens rise measured by Pentacam were negatively correlated with vault. Results of GEE model showed preoperative PD, age, cylindrical power of TICL and size-WTW were influencing factors for postoperative vault., Conclusions: Vault after TICL implantation is higher than that with ICL. PD, age, cylindrical power of TICL and size-WTW could affect postoperative vault., (© 2020 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: To evaluate the visual quality of myopic patients after non-toric versus toric implantable collamer lens (ICL and TICL, respectively) V4c, and to investigate the potential risk factors of postoperative night vision disturbances., Methods: This prospective cohort study included 42 eyes of 21 patients treated with ICL and 46 eyes of 23 patients treated with TICL. Refractive parameters and ocular aberrations were examined before and 6 months after surgery. Subjective quality of vision was scored by a validated questionnaire., Results: The efficacy index at 6 months was 1.14 ± 0.20 for ICL and 1.17 ± 0.16 for TICL; the safety index was 1.20 ± 0.17 for ICL and 1.20 ± 0.19 for TICL. The root mean square of total higher-order aberrations (HOAs) and trefoil was significantly increased, and no statistical differences between groups were detected in HOA changes. Many patients reported haloes (85.7% for ICL and 100% for TICL) and glare (76.2% for ICL and 65.2% for TICL), but most (94.4% for ICL and 95.5% for TICL) were satisfied or very satisfied with visual outcomes. Implantable collamer lens (ICL) toricity was the risk factor for frequency (OR = 2.81, p = 0.01), severity (OR = 3.85, p = 0.003) and bothering effect (OR = 2.89, p = 0.01) of haloes., Conclusions: Implantable collamer lens and TICL provided comparable efficacy, safety and predictability, induced acceptable level of HOAs and achieved high satisfaction in correcting myopia and myopic astigmatism. Although not severe, haloes and glare have a non-negligible prevalence and ICL toricity is a potential risk factor of haloes., (© 2020 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: To determine the incidence, management, outcomes, and risk factors of suction loss during femtosecond laser small incision lenticule extraction (SMILE) for the treatment of myopia and myopic astigmatism., Methods: The study reviewed 12,057 consecutive eyes treated with SMILE. Eyes that developed suction loss (study group) or underwent uneventful SMILE (control group) were analyzed. Corneal topography, manifest refractions, and measurements of uncorrected (UDVA) and corrected (CDVA) distance visual acuities were evaluated preoperatively and postoperatively after 1 day and 12 months. Risk factors were determined for suction loss development., Results: Twenty-seven of 12,057 eyes (0.22%) were enrolled in the study group and 50 eyes in the control group. Suction loss occurred in 14 eyes during the cutting of the refractive lenticule, 7 eyes during the cutting of the cap, and 6 eyes during the creation of the cap small incision. There was no statistically significant difference between the two groups in logMAR UDVA (P = .52) or CDVA (P = .59). A novel method of increasing cap thickness was applied to 8 eyes when suction loss occurred after more than 10% of the lenticule was cut. The eye being operated on first (the right eye) (P = .02) and a thinner lenticule (P = .006) were associated with a significantly higher risk of developing suction loss., Conclusions: The incidence of suction loss was low. The novel method achieved visual and refractive outcomes as favorable as those of uneventful SMILE procedures. The first eye that was operated on had a higher risk for the development of suction loss. [J Refract Surg. 2020;36(5):308-316.]., (Copyright 2020, SLACK Incorporated.)

Purpose: To investigate early visual and refractive outcomes, corneal stability and optical quality after femtosecond laser small-incision lenticule extraction (SMILE) for treating myopia and myopic astigmatism over -10 D., Methods: Thirty eyes (30 patients) with myopia and myopic astigmatism of over -10 D were treated with VisuMax ® femtosecond laser (version 3.0; Carl Zeiss Meditec AG, Jena, Germany). Six months postoperative safety, efficacy and predictability were evaluated. Corneal Scheimpflug topography was measured preoperatively, 1 day, 3 months and 6 months postoperatively. Wavefront aberrations were measured preoperatively, 3 months and 6 months postoperatively., Results: Six months postoperatively, LogMAR uncorrected and corrected distance visual acuity (CDVA) were -0.013 ± 0.086 and -0.073 ± 0.069, respectively. 73% (97%) of eyes were within 0.5 (1) D of target refraction. No eyes lost CDVA, 43% (13 eyes) gained one line and 7% (two eyes) gained two lines. Mean corneal back curvature (KMB) and posterior central elevation (PCE) did not change significantly comparing preoperative and 6 months postoperative data (p = 0.91 and 0.77, respectively). Comparing 1 day with 6 months postoperative data, central corneal thickness (CCT), mean corneal front curvature (KMF), KMB and PCE did not change significantly (p = 0.27, 0.07, 0.52, 0.71, respectively). Total higher-order aberration (HOA), spherical aberration and coma increased significantly (p < 0.01) but trefoil remained stable (p = 0.49)., Conclusion: Our results indicate that SMILE can correct myopia and myopic astigmatism of over -10 D predictably. No early ectasia was observed. Long-term changes in visual quality and corneal stability require further investigation., (© 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: To investigate the changes of posterior corneal elevation after small incision lenticule extraction (SMILE) for moderate and high myopia., Methods: In this prospective study, fifty consecutive eyes of thirty patients (10 male, 20 female) who underwent SMILE for myopia and myopic astigmatism were included. Eyes were divided in two groups based on the preoperative spherical equivalent refraction: high myopia group (32 eyes, range -6.25D to -10.00D) and moderate myopia group (18 eyes, range -3.00D to -6.00D). Posterior corneal surfaces were measured by a Scheimpflug camera (Pentacam, Oculus Germany) preoperatively and 1 month, 3 months, 6 months and 12 months postoperatively. Posterior central elevation (PCE) and posterior mean elevation (PME) at 17 predetermined points in the central-4mm area above the best-fit sphere were analyzed., Results: No significant difference in the amount of posterior corneal elevation changes in the high myopia group was noted over time (P = 0.23 and P = 0.94 for PCE and PME, respectively). Similarly, the changes in the moderate myopia group before and after SMILE were not significant either (P = 0.34 and P = 0.40 for PCE and PME). A statistically significant correlation was found between the residual bed thickness and the shift of the PCE in the high myopia group at 12 months postoperatively (r = 0.53, P = 0.01)., Conclusions: The results of this study suggest that the posterior corneal surface remain stable within one year after SMILE for both moderate and high myopia. The changes of PCE correlate to the residual bed thickness for high myopia. Long-term changes of posterior corneal surface need further investigation.

Purpose: To evaluate the influence of the origin of astigmatism on the correction of myopia or myopic astigmatism by femtosecond laser small-incision lenticule extraction (SMILE)., Setting: Ophthalmology Department, Eye and ENT Hospital, Shanghai, China., Design: Prospective case series., Methods: Small-incision lenticule extraction was performed to correct myopia or myopic astigmatism. Ocular residual astigmatism (ORA) was determined by vector analysis using manifest refraction and Scheimpflug camera imaging of the anterior cornea. Patients were divided into 2 groups according to ORA (high >1.0 diopter [D]; low ≤1.0 D), and procedural efficacy was compared. Patients were examined preoperatively and 1, 3, and 6 months postoperatively., Results: This study comprised 122 right eyes of 122 patients. No significant difference was found in the preoperative manifest astigmatism (target-induced astigmatism [TIA]) between the low ORA group (n = 67) and high ORA group (n = 55). The mean postoperative manifest astigmatism was higher in the high ORA group at all postoperative timepoints (1 month: t = 2.182, P=.031; 3 months: t = 2.30, P=.023; 6 months: t = 2.193, P=.03). The mean index of success (postoperative astigmatism/TIA) was 0.68 in the high ORA group and 0.34 in the low ORA group 1 month postoperatively (t = 2.531, P=.013); 0.73 and 0.39, respectively, at 3 months (t = 2.689, P=.008); and 0.77 and 0.46, respectively, at 6 months (t = 2.105, P=.037)., Conclusion: Small-incision lenticule extraction was effective in correcting astigmatism but may be less effective in correcting ORA., (Copyright © 2015. Published by Elsevier Inc.)

Purpose: To measure decentration following femtosecond laser small incision lenticule extraction (SMILE) for the correction of myopia and myopic astigmatism in the early learning curve, and to investigate its impact on visual quality., Methods: A total of 55 consecutive patients (100 eyes) who underwent the SMILE procedure were included. Decentration was measured using a Scheimpflug camera 6 months after surgery. Uncorrected and corrected distance visual acuity (UDVA, CDVA), manifest refraction, and wavefront errors were also measured. Associations between decentration and the preoperative spherical equivalent were analyzed, as well as the associations between decentration and wavefront aberrations., Results: Regarding efficacy and safety, 40 eyes (40%) had an unchanged CDVA; 32 eyes (32%) gained one line; and 11 eyes (11%) gained two lines. Fifteen eyes (15%) lost one line of CDVA, and two eyes (2%) lost two lines. Ninety-nine of the treated eyes (99%) had a postoperative UDVA better than 1.0, and 100 eyes (100%) had a UDVA better than 0.8. The mean decentered displacement was 0.17 ± 0.09 mm. The decentered displacement of all treated eyes (100%) was within 0.50 mm; 70 eyes (70%) were within 0.20 mm; and 90 eyes (90%) were within 0.30 mm. The vertical coma showed the greatest increase in magnitude. The magnitude of horizontal decentration was found to be associated with an induced horizontal coma., Conclusions: This study suggests that, although mild decentration occurred in the early learning curve, good visual outcomes were achieved after the SMILE surgery. Special efforts to minimize induced vertical coma are necessary., (Copyright 2014 The Association for Research in Vision and Ophthalmology, Inc.)

Background: This study compares the clinical outcomes of femtosecond laser small-incision lenticule extraction (SMILE) for the correction of myopia and myopic astigmatism greater than - 10 D, and - 10 D or less respectively.Methods: 60 eyes/patients were equally selected into group 1 (myopia and myopic astigmatism of - 10 D or less) and group 2 (myopia and myopic astigmatism of over - 10 D), both of which were treated with SMILE. Visual and refractive outcomes, corneal higher-order aberrations, and Bowman's layer micro-distortions were evaluated preoperatively, 3 months, and 6 months postoperatively.Results: LogMAR corrected distance visual acuity (CDVA) of group 1 and group 2 was - 0.069 ± 0.047 and - 0.053 ± 0.073 6 months postoperatively (P = 0.48). 100% eyes in group 1 and 97% in group 2 were within 1 D of targeted correction (P = 0.45). Meanwhile, 100% eyes in group 1 and 97% in group 2 had an uncorrected distance visual acuity of 20/25 or better (P = 0.20). Changes in corneal higher-order aberrations root mean square, coma, and trefoil were similar between the two groups but spherical aberration was higher in group 2 (P < 0.01). Micro-distortions were observed in 53% in group 1 and 77% in group 2. More micro-distortions were observed in group 2 (3.40 ± 2.66) than in group 1 (2.07 ± 2.29) (P = 0.041). The total number of micro-distortions was not correlated with postoperative CDVA (P = 0.77).Conclusions: Visual outcomes showed similar results of SMILE for myopic correction of > - 10 D and ≤ - 10 D. Refractive outcomes showed slightly under-correction in higher myopic eyes. Higher myopic treatment tends to induce more spherical aberrations. Micro-distortions had no impact in visual and refractive outcomes. [ABSTRACT FROM AUTHOR]