BACKGROUND: To evaluate the possible topographic and surgical risk factors for high postoperative residual astigmatism in patients who undergo small-incision lenticule extraction (SMILE) surgery and have different myopia degrees.
METHODS: A retrospective cohort study was conducted, and patients who underwent SMILE surgery were enrolled. A total of 80 and 150 eyes from 40 to 75 individuals, respectively, were selected as the low myopia and high myopia groups. The demographic data, visual acuity, refraction, topographic parameters and surgical settings were recorded. Multiple linear regression with interaction tests were performed to survey the risk factors for high postoperative residual astigmatism in each group.
RESULTS: Five (6.25%) and 9 (6.00%) eyes presented with high postoperative residual astigmatism in the low myopia and high myopia groups, respectively, but these differences were not significant (P = 0.569). A steep corneal curvature was correlated with a greater risk of high postoperative residual astigmatism in the low myopia group (P = 0.015), while a higher degree of cycloplegic cylinder power, steeper corneal curvature, greater topographic cylinder power, smaller optic zone and longer incision length were associated with a high rate of postoperative residual astigmatism in the high myopia group (all P < 0.05). In addition, the interaction effects of cycloplegic and topographic cylinder power and longer incision length on the incidence of high postoperative residual astigmatism development were more evident in the high myopia group than in the low myopia group (all P < 0.05).
CONCLUSIONS: A steep corneal curvature correlates with a high risk of high postoperative residual astigmatism after SMILE surgery, and a higher degree of cycloplegic and topographic cylinder and longer incision are associated with high postoperative residual astigmatism in individuals with high myopia.

BACKGROUND: To compare the 4-year visual outcomes of implantable collamer lens V4c (EVO-ICL) implantation and small incision lenticule extraction (SMILE) for high myopia and astigmatism.
METHODS: This retrospective case study included 64 eyes of 40 patients. These patients with preoperative manifest refraction spherical equivalent (SE) between - 6.00 and - 10.00 diopters (D) were screened from the database of SMILE and EVO-ICL implantation procedures in 2015. The ICL group [32 eyes of 19 patients (mean age, 29.6 ± 6.3 years); mean SE, -8.71 ± 1.06 D] and SMILE group [32 eyes of 21 patients (mean age, 27.7 ± 5.6 years); mean SE, -8.35 ± 0.65D] were compared. All patients were then prospectively examined at a four-year follow-up for routine postoperative examinations, higher-order ocular aberrations, retinal image quality and a questionnaire.
RESULTS: The safety indexes were 1.15 ± 0.14 and 1.22 ± 0.21 (P = 0.36) for the SMILE and ICL groups, respectively. No eyes lost two or more lines of CDVA in either group. The efficacy indexes were 0.97 ± 0.16 and 0.96 ± 0.19 (P = 0.87), respectively. Twenty-three eyes (72%) in ICL and 26 eyes (81%) in SMILE groups were within ± 0.5 D of the attempted SE (P < 0.01). ICL-treated eyes had significantly less spherical aberration and coma (P < 0.01 and < 0.05, respectively) postoperatively. Halos were the prevalent visual disturbance in both groups.
CONCLUSIONS: SMILE and EVO-ICL implantation provided safe and effective correction of high myopia. SMILE showed slightly better long-term predictability. Mild postoperative visual disturbances were observed after ICL and SMILE at 4-year follow-up.

OBJECTIVE: To compare the subjective and objective visual quality between small incision lenticule extraction (SMILE) and transepithelial photorefractive keratectomy (tPRK) in patients with low and moderate myopia.
METHODS: Patients undertaking SMILE or tPRK for the correction of low and moderate myopia were consecutively recruited in this prospective cohort study with a 3-month follow-up period. Objective evaluation [visual acuity test, manifest refraction, wavefront aberrations, the total cut-off value of the total modulation transfer function (MTFcut-off), and Strehl ratio (SR)] and subjective evaluation of visual quality (quality-of-life questionnaire) were conducted before surgery and at days 1, 7, 30, and 90 after surgery.
RESULTS: A total of 47 patients (94 eyes) with SMILE and 22 patients (22 eyes) with tPRK were enrolled. The uncorrected visual acuity (UCVA) was better in SMILE patients on day 7 after surgery (1.13±0.13 vs 0.99±0.17, t=4.85, P<0.001) but was comparable at days 30 and 90. At day 90, the SMILE group had a lower spherical equivalent (SE) than the tPRK group (0.04±0.31 vs 0.19±0.43, t=2.08, P=0.042). Total higher order aberrations (HOAs) were induced in both surgical types, which were more evident in the tPRK group with 3-mm pupil diameter (0.16±0.07 vs 0.11±0.05, t=4.27, P<0.001) and 5-mm pupil diameter (0.39±0.17 vs 0.36±0.11, t=2.33, P=0.022). The MTFcut-off and SR showed a trend of improvement in both SMILE and tPRK patients but were statistically better in the SMILE group with both pupil diameters. There was a significant improvement of contrast sensitivity (CS) over baseline levels at the spatial frequency of 18 cycles/degree (c/d) in the SMILE group (F=2.72, P=0.033) and at 3 c/d (F=3.03, P=0.031), 12 c/d (F=3.72, P=0.013), and 18 c/d (F=4.62, P=0.004) in the tPRK group. The subjective quality of life questionnaire showed a steady improvement in the SMILE group (F=8.31, P<0.001) but not the tPRK group.
CONCLUSIONS: SMILE and tPRK are both safe and effective ways to correct low and moderate myopia. A generally better and quicker recovery of visual quality favors the application of SMILE in qualified patients.

OBJECTIVE: To investigate the size of functional optical zone (FOZ) after small incision lenticule extraction (SMILE) versus femtosecond laser assisted excimer laser keratomileusis (FS-LASIK) for myopia correction and potential associated factors for FOZ.
METHODS: A total of 133 patients who received corneal refractive surgery in our hospital between November 2018 and July 2021 were retrospectively enrolled. There were 63 patients (123 eyes) in SMILE group and 70 patients (139 eyes) in FS-LASIK group. The size of FOZ was measured using Pentacam 3-dementional anterior segment analyzer before and 3mo after surgery, so as to analyze postoperative achieved functional optical zone (AFOZ) and its contributing parameters.
RESULTS: When planned functional optical zone (PFOZ) was 6.5 mm for both groups, AFOZ was 1.45±0.27 and 1.67±0.25 mm smaller than preoperative FOZ in SMILE group and FS-LASIK group 3mo after surgery. AFOZ in SMILE group was significantly larger than that in FS-LASIK group (P<0.001). Variation of FOZ was negatively correlated with preoperative spherical equivalent (SE) and positively correlated with variation of mean keratometry value (ΔKm), variation of spherical aberration (ΔSA), and variation of Q-value (ΔQ, all P<0.001) in both groups. Multiple variable linear regression equations were ΔFOZ=1.354-0.1×pre-SE+0.336×ΔQ+1.462×ΔSA in SMILE group and ΔFOZ=1.512+0.137×ΔQ+0.468×ΔSA in FS-LASIK group.
CONCLUSIONS: AFOZ is significantly smaller than preoperative FOZ in both SMILE and FS-LASIK groups. With the same PFOZ, larger AFOZ is achieved in SMILE group than in FS-LASIK group.

BACKGROUND: Implantable collamer lens implantation (ICL) is a form of \'foldable\' posterior chamber phakic intraocular lens refractive surgery that generally does not impair cornea and natural accommodation. The potential advantages of the ICL over keratorefractive laser procedures include less induction of higher-order aberrations (HOAs) and enhanced retinal image magnification. On the other hand, small incision lenticule extraction (SMILE), currently, one of the most popular refractive surgery procedures, also offers excellent visual outcomes, particularly for eyes with low to moderate amounts of myopia. The aim of this study is to evaluate whether ICL/TICL (toric ICL) is comparable to SMILE for low to moderate myopia in terms of refractive outcomes at 3 and 18 months post-operatively.
METHODS: This is a prospective randomized study. A total of 300 participants will be randomized into two groups, the ICL/TICL group and SMILE group. Eligible participants with spherical equivalent (SE) less than - 6.0 diopter (D) will be recruited. Following randomization, participants will be followed at 1, 3, 6, 12, and 18 months. The primary outcome is the refractive predictability at every postoperative point after surgery, which is the proportion of the number of eyes achieving a postoperative SE within ± 0.5 D and ± 1.0 D of the intended target. Secondary outcome parameters include visual acuity, refraction, adverse events, and quality of vision measurements.
CONCLUSIONS: This trial will provide information on whether ICL has comparable, if not superior, refractive outcomes compared to the established SMILE for low to moderate myopia, thus providing evidence for translation into clinical practice.
BACKGROUND: Chinese clinical trial registry (ChiCTR) 2200055372. Registered on 08 January 2022.

BACKGROUND: To evaluate the influence of preoperative optical zone on myopic correction in small incision lenticule extraction.
METHODS: In this retrospective clinical study, 581 eyes from 316 patients underwent SMILE were selected, including 117 eyes in the small optical zone group (range from 6.0 to 6.4 mm) and 464 eyes in the large optical zone group (range from 6.5 to 6.8 mm). The measurements included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical, and cylinder were measured preoperatively and 3 months postoperatively. Propensity score match (PSM) analysis was performed with age, gender, eye (right/left), keratometry and preoperative spherical equivalent between two different groups. The influence of optical zones on postoperative refractive outcomes were evaluated using univariate regression analysis.
RESULTS: In total, 78 pairs of eyes were selected by PSM (match ratio 1:1). There were no differences in the age, gender, eye (right/left), keratometry or preoperative spherical equivalent between the small and large optical zone groups. However, the difference of postoperative spherical equivalent was significantly between groups. Patients with larger optical zones had a trend towards less undercorrection (P = 0.018). Univariate linear regression model analysis found that each millimeter larger optical zone resulted in 8.13% or 0.39D less undercorrection (P < 0.001). The dependency between the optical zones and postoperative spherical equivalent was significant in the higher preoperative myopia group (r = 0.281, P < 0.001), but not significant in the lower myopia group (r = 0.028, P = 0.702).
CONCLUSIONS: The diameter of optical zones would affect postoperative refractive outcomes in small incision lenticule extraction. This study indicated that larger optical zones induced less undercorrection, especially in patients with high myopia.

OBJECTIVE: The aim of this study was to determine risk factors affecting changes in posterior corneal elevation (PCE) and predict the 5-year stability after small incision lenticule extraction (SMILE).
METHODS: This retrospective, longitudinal study enrolled 161 patients post-SMILE. The PCE values were measured at the apex, thinnest, maximal and 24 other prespecified preoperative points and at 6 months, 1 year and 5 years postoperatively.
RESULTS: Posterior corneas exhibited time-dependent, region-dependent and angle-dependent changes. For every dioptre increase in the absolute preoperative spherical equivalent (SE), 10-μm decrease in the central corneal thickness (CCT), 10-μm increase in the maximum lenticule thickness (MLT), 10-μm decrease in the residual bed thickness (RBT), 10% increase in the percentage ablation depth (PAD, MLT divided by CCT) and 10% decrease in the percentage stromal bed thickness (PSBT, RBT divided by CCT), PCE exhibited average forward displacements of 0.2-0.4, 0.2-0.7, 0.1-0.2, 0.1-0.3, 0.6-1.0 and 0.5-1.1 μm, respectively (p < 0.05). PSBT was the variable with the highest accuracy in predicting 5-year stability of posterior corneas (area under curve = 0.75). The cut-off values of SE, CCT, MLT, RBT, PAD and PSBT for increased PCE were -8.00 to -8.31 D, 481.0-498.5 μm, 139.5-144.5 μm, 255.5-263.5 μm, 26.9-28.3% and 48.9-52.6%, respectively.
CONCLUSIONS: Eyes with thinner corneas, higher myopia requiring greater MLT and lower RBT exhibited greater predispositions towards posterior protrusion. The thresholds for preventing forward posterior corneal displacement were 26.9-28.3% for PAD and 48.9-52.6% for PSBT. Prediction of posterior corneal stability is useful for assessing surgical risks post-SMILE.

BACKGROUND: To investigate nighttime symptoms in patients with myopic anisometropia after monocular small incision lenticule extraction (SMILE) surgery.
METHODS: Thirty-six patients who had undergone monocular SMILE more than 6 months previously were recruited at the Eye & ENT Hospital of Fudan University. The average age at surgery was 25.4 ± 6.1 years. Preoperative spherical equivalent (SE) was -3.77 ± 1.56 D in SMILE-treated eyes and -0.08 ± 0.66 D in unoperated eyes. Main measurements included uncorrected and corrected distance visual acuity, manifest refraction, halo radius, contrast sensitivity, nighttime symptoms, and patient satisfaction.
RESULTS: The mean follow-up time was 13.9 ± 3.4 months. The efficacy and safety indexes were 1.18 and 1.28, respectively. The halo radius was not significantly different between SMILE-treated and unoperated eyes under luminance conditions of 1, 5, and 100 cd/m2 (P = 0.055). No significant differences were observed in contrast sensitivity at all spatial frequencies between eyes under both uncorrected and corrected conditions (all P > 0.05). None of the patients reported moderate or severe symptoms at night. Mild symptoms (glare, halo, starburst) were reported and binocularly equal in 13 patients, whereas four patients reported better night vision in SMILE-treated eyes than unoperated eyes, and one of them experienced mild night vision disturbance. The overall satisfaction score was 9.39 ± 0.80.
CONCLUSIONS: The disk halo size and contrast sensitivity in SMILE-treated eyes were similar to those in unoperated eyes, and nighttime symptoms almost completely resolved after SMILE.

BACKGROUND: There are few reports regarding the influence of varying illumination on the compensation effect before and after corneal refractive surgery. We aimed to evaluate the changes in refraction, higher-order aberrations, and aberration compensation between mesopic and photopic illumination before and after small incision lenticule extraction.
METHODS: In this prospective cohort study, only the right eyes of patients who underwent small incision lenticule extraction for the correction of myopia and myopic astigmatism at the Tianjin Eye Hospital were included. Wavefront refraction and higher-order aberrations were measured preoperatively and 3 months postoperatively under mesopic and photopic illumination. Compensation factors were calculated as 1 - (aberration of the whole eye/aberration of the anterior corneal surface).
RESULTS: Forty patients undergoing small incision lenticule extraction were enrolled. All surgeries were completed without postoperative complications. Preoperatively, the eyes only had a statistically significantly higher (t = - 4.589, p < .001) spherical refractive error under mesopic vs. photopic illumination (median [interquartile range], - 6.146 [2.356] vs. - 6.030 [2.619] diopters [D]), whereas postoperatively, the eyes also exhibited statistically significantly higher (t = - 3.013, p = .005) astigmatism (- 0.608 [0.414] vs. - 0.382 [0.319] D). Differences in spherical refraction between the two illuminations were the highest in postoperative eyes (Δ > 0.5 D). Only postoperative eyes exhibited statistically significant elevations (t ≥ 4.081, p < .001) in higher-order aberrations under mesopic illumination, and only preoperative eyes exhibited statistically significantly enhanced (χ2 = 6.373, p = .01 for fourth-order and χ2 = 11.850, p = .001 for primary spherical aberrations) and decreased (χ2 = 13.653, p = .001 for horizontal trefoil) compensation factors under mesopic illumination.
CONCLUSIONS: Exaggerations in higher-order aberrations and myopic shift after small incision lenticule extraction became apparent under mesopic illumination. Slight undercorrection may have an enhanced effect under low illumination and may reduce night vision. The specific changes in compensation effects in preoperative eyes may improve optical quality under mesopic illumination. Postoperative eyes have reduced compensation ability, specifically for spherical aberrations, under mesopic illumination, which may diminish night vision. Further studies that include the measurement of subjective night vision parameters should be conducted.

The aim of the present study was to investigate the histological and morphological characteristics of corneal stromal lenticules extracted during femtosecond laser-assisted small incision lenticule extraction (SMILE) surgery by light and electron microscopy. A total of 20 human corneal stromal lenticules extracted during SMILE surgery were sent for microscopic examination immediately after surgery. Of these, six were observed under a light microscope and 14 were observed under an electron microscope. The smoothness of the front and rear surface of the lenticules observed under an electron microscope was rated on a scale of 0 to 4 according to unified evaluation criteria and the scores were statistically compared. Under the light microscope, the edge of the cross section of the corneal stromal lenticules was deeply stained and certain burrs and broken collagen fibers were observed. The swollen corneal stromal fibers were distributed irregularly, with a few bubbles of different sizes. Under the electron microscope, the surface of the lenticules ablated using a femtosecond laser was not perfectly smooth and the front surface was smoother than the rear surface. The side edge of the lenticules ablated using a femtosecond laser was not as regular as the edge cut using microscissors. Necrosis and dissolution of collagen fibers were observed near the surface of the lenticules. In conclusion, the surface quality of corneal stromal lenticules ablated using a femtosecond laser was not optimal when observed under a microscope. Increased attention should be paid to the histology and morphology of the corneal surface following laser ablation.