Changes in posterior corneal elevation after small incision lenticule extraction for different myopic diopters

●AIM:To study the changes and effect factors of posterior corneal surface after small incision lenticule extraction(SMILE)with different myopic diopters.●METHODS:Ninety eyes of 90 patients who underwent SMILE were included in this retrospective study.Patients were allocated into three groups based on the preoperative spherical equivalent(SE):low myopia(SE≥-3.00 D),moderate myopia(-3.00 D>SE>-6.00 D)and high myopia(SE≤-6.00 D).Posterior corneal surfaces were measured by a Scheimpflug camera preoperatively and different postoperative times(1wk,1,3,6mo,and 1y).Posterior mean elevation(PME)at 25 predetermined points of 3 concentric circles(2-,4-,and 6-mm diameter)above the best fit sphere was analyzed.●RESULTS:All surgeries were completed uneventfully and no ectasia was found through the observation.The difference of myopia group was significant at the 2-mm ring at 1 and 3mo postoperatively(1mo:P=0.017;3mo:P=0.018).The effect of time onΔPME was statistically significant(2-mm ring:P=0.001;4-mm ring:P<0.001;6-mm ring:P<0.001).The effect of different corneal locations onΔPME was significant except 1wk postoperatively(1mo:P=0.000;3mo:P=0.000;6mo:P=0.001;1y:P=0.001).Posterior corneal stability was linearly correlated with SE,central corneal thickness,ablation depth,residual bed thickness,percent ablation depth and percent stromal bed thickness.●CONCLUSION:The posterior corneal surface changes dynamically after SMILE.No protrusion is observed on the posterior corneal surface in patients with different degrees of myopia within one year after surgery.SMILE has good stability,accuracy,safety and predictability.

Ten-year observation of corneal densitometry and associated factors following small incision lenticule extraction

●AIM:To investigate the long-term changes of corneal densitometry(CD)and its contributing elements after small incision lenticule extraction(SMILE).●METHODS:Totally 31 eyes of 31 patients with mean spherical equivalent of-6.46±1.50 D and mean age 28.23±7.38y were enrolled.Full-scale examinations were conducted on all patients preoperatively and during followup.Visual acuity,manifest refraction,axial length,corneal thickness,corneal higher-order aberrations,and CD were evaluated.●RESULTS:All surgeries were completed successfully without complications or adverse events.Ten-year safety index was 1.17±0.20 and efficacy 1.04±0.28.CD value of 0–6 mm zones in central layer was statistically significantly lower 10y postoperatively,compared with preoperative values(0–2 mmΔ=-1.62,2–6 mmΔ=-1.24,P<0.01).There were no correlations between CD values and factors evaluated.●CONCLUSION:SMILE is a safe and efficient procedure for myopia on a long-term basis.CD values get lower 10y postoperatively,whose mechanism is to be further discussed.

Postoperative efficacy,safety,predictability,and visual quality of implantable collamer lens implantation versus small incision lenticule extraction in myopic eyes:a Meta-analysis

AIM:To compare the postoperative efficacy,safety,predictability,and visual quality of implantable collamer lens(ICL)implantation versus small incision lenticule extraction(SMILE)in myopia eyes.METHODS:Pub Med,EMBASE,Web of Science,Cochrane Library and several Chinese databases were searched at May 2021 to select relevant studies in comparison of clinical outcomes between ICL implantation and SMILE for myopia.The primary outcomes were efficacy,safety,and predictability.And the secondary outcomes were postoperative higher-order ocular aberrations(HOAs),modulation transfer function cutoff frequency(MTF),objective scatter index(OSI),contrast sensitivity and a quality of vision(Qo V)questionnaire.RESULTS:A total of 1036 eyes from 10 studies,of which 503 eyes underwent ICL implantation and 533 eyes underwent SMILE,were enrolled in this Meta-analysis.Pooled results revealed that ICL group had a better safety index and post-corrected distance visual acuity(CDVA)(P=0.007,<0.00001,respectively),and a lower percentage of eyes with a postoperative CDVA lost 1 line(P=0.007)than the SMILE group.No significant differences were found in comparison of the other primary outcomes.In the longterm follow-up(>6mo),ICL group had a lower total HOA,coma,and spherical aberration than SMILE group(P=0.003,<0.00001,0.04).Yet higher trefoil was found in ICL group at 6mo after surgery(P=0.003).Additionally,ICL group also had a higher MTF value(P=0.02),and a higher contrast sensitivity score for spatial frequencies of 1.5,6,and 12 cpds(P=0.02,0.005,0.02,respectively).And it also had a lower score of bothersome in Qo V questionnaire than SMILE group(P=0.003).CONCLUSION:ICL implantation and SMILE have similar and comparable outcomes in term of the efficacy and predictability for correcting high myopia.However,ICL group is relatively safer and also has better visual quality in comparison of SMILE group.

Small incision lenticule extraction and femtosecond-assisted laser in situ keratomileusis in patients with deep corneal opacity:case series

AIM:To report the safety,efficacy,and accuracy of small-incision lenticule extraction(SMILE)or femtosecondassisted laser in situ keratomileusis(FS-LASIK)for the correction of myopia or myopic astigmatism in patients with deep corneal opacity denoted by anterior segment optical coherence tomography(AS-OCT).METHODS:Four patients with monocular corneal opacity(3 due to mechanical injury,1 due to a firecracker wound)were recruited and treated with refractive surgery(3 for SMILE,1 for FS-LASIK combined with limbal relaxing incision(LRI).Preoperative ocular manifestations,surgical details,postoperative visual outcomes,corneal opacity parameters,and corneal topography were analyzed.RESULTS:Preoperatively,spherical diopter ranged from-3.0 D to-4.75 D with cylinder ranging from-0.75 to-5.0 D,and corrected distance visual acuity(CDVA)ranging from 20/25 to 20/20.One eye’s corneal opacity was located in the central zone and three were in the mid-peripheral optical zone.Three patients underwent uneventful SMILE in both eyes,whilst one patient underwent FS-LASIK for high astigmatism in both eyes and LRI in the right eye.CDVA of the eye with corneal opacity ranged from 20/22to 20/20 one to six weeks postoperatively.Two patients achieved better CDVA and no patients lost Snellen lines.The postoperative diopter was within±0.75 D for all eyes.Significant edema existed above the corneal opacity in one eye and dissipated soon.No eccentric corneal topography or morphological anomaly of the corneal cap or flap was observed.CONCLUSION:The cases demonstrate that SMILE or FS-LASIK is safe and effective to treat myopic astigmatism combined with deep corneal opacity lesions after comprehensive preoperative evaluation and appropriate candidate selection.FS-LASIK combined with LRI is also sufficient for correcting high astigmatism due to corneal scarring.

Effectiveness and the nomogram of small incision lenticule extraction in the correction of myopic anisometropia in adults

AIM:To evaluate the safety,effectiveness,and predictability of small incision lenticule extraction(SMILE)for the treatment of anisometropia,and to explore the personalized design scheme of SMILE in correcting adult myopia anisometropia based on the nomogram.METHODS:It’s a prospective cohort study.Patients with anisometropic myopia of refractive difference≥2.0 diopters(D)who underwent SMILE between September 2020 and March 2021 were enrolled.Clinical features and visual function were assessed preoperatively and at 1wk,1,3,and 6mo after the operation.The examination included tests for uncorrected distance visual acuity(UDVA),corrected distance visual acuity(CDVA),refractive errors,effectiveness index(preoperative CDVA/postoperative UDVA),safety index(postoperative CDVA/preoperative CDVA),nomogram and stereoscopic function.Paired t-test,Wilcoxon signed-rank test and repeated-measures analyses of variance were used for continuous variables,and Pearson Chi-squared test was used for categorical variables.RESULTS:The study involved 45 consecutive patients(average age:25.0±6.9y;82 out of 90 eyes underwent SMILE,while 8 eyes were not operated).The average preoperative spherical equivalent(SE)was-4.74±0.22 D.Six months after surgery,the effectiveness index was 1.05±0.12,and the safety index was 1.09±0.11.Seventy eyes(85.4%)exhibited SE correction error within±0.5 D.The percentage of eyes with Titmus stereoscopic function equal to or less than 200”significantly increased from 55.6%preoperatively to 88.9%postoperatively(P<0.05).There was statistically significant difference between higher myopia eyes and contralateral eyes in average nomogram value/spherical refraction ratio.CONCLUSION:SMILE is safe,effective and predictable in correcting myopic anisometropia,and it improves stereoscopic visual function of anisometropia patients.The precise and individualized design of the nomogram is a vital element to ensure the balance of both eyes after SMILE.

A 3-month comparison study of subjective and objective visual quality of small incision lenticule extraction and transepithelial photorefractive keratectomy in patients with low and moderate myopia

AIM:To compare the subjective and objective visual quality between small incision lenticule extraction(SMILE)and transepithelial photorefractive keratectomy(t PRK)in patients with low and moderate myopia.METHODS:Patients undertaking SMILE or t PRK 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 t PRK 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 t PRK 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 t PRK group with 3-mm pupil diameter(0.16±0.07 vs0.11±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-offand SR showed a trend of improvement in both SMILE and t PRK 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 t PRK group.The subjective quality of life questionnaire showed a steady improvement in the SMILE group(F=8.31,P<0.001)but not the t PRK group.CONCLUSION:SMILE and t PRK 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.

Comparative study of functional optical zone:small incision lenticule extraction versus femtosecond laser assisted excimer laser keratomileusis

AIM: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 70patients(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(△Km),variation of spherical aberration(△SA),and variation of Q-value(△Q,all P<0.001)in both groups.Multiple variable linear regression equations were△FOZ=1.354-0.1×pre-SE+0.336×△Q+1.462×△SA in SMILE group and△FOZ=1.512+0.137×△Q+0.468×△SA in FS-LASIK group.CONCLUSION: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.

Treatment of corneal dermoid with lenticules from small incision lenticule extraction surgery:a surgery assisted by fibrin glue

AIM:To observe the clinical efficacy of the combined use of small incision lenticule extraction(SMILE)-derived lenticule patches in corneal dermoid excision,with fixation of the lenticule patches assisted by fibrin glue.METHODS:Seventeen eyes of 17 patients with corneal dermoid were treated with dermoid removal combined with SMILE-derived lenticule transplantation.All lenticule patches were fixed by fibrin glue.Ocular changes were assessed using slit lamp microscopy and anterior-segmental optical coherence tomography.The best-corrected visual acuity(BCVA)and ocular dioptric variations were examined preoperatively and postoperatively.Intraocular pressure(IOP)was also monitored in all visited time.RESULTS:Totally,18 lenticule patches were used on 17 eyes of 17 cornea dermoid patients.The mean follow-up time was 11.47±5.28mo.All lenticule patches we resuccessfullyg lued,kept on its location and maintained transparent during the follow-up time,with a consecutive epithelial cover for 1wk.Nine of the patients could coordinate visual and optometry exam well.Their preoperative BCVA is 0.60±0.35 in decimal,significantly improved to 0.80±0.26 in decimal at 6mo postoperatively(Z=-2.392,P=0.017),but the changes of their corneal astigmatism diopters showed no significance,with 2.22±1.91 D preoperatively,and 2.28±1.31 D at 6mo postoperatively(Z=-0.135,P=0.893).Limbal pannus formation occurred in 4(23.52%)cases and decreased with the application of tacrolimus eyedrops.IOP increased in 2(11.76%)cases,but well decreased by timolol maleate eyedrops.All the adult patients or guardians of minor patients were satisfied with the cosmetic improvement.CONCLUSION:Dermoid excision combined with transplantation of SMILE-derived lenticule patches using fibrin glue is a safe and effective novel tectonic keratoplasty procedure for corneal dermoid.

Three-year results of small incision lenticule extraction and wavefront-guided femtosecond laser-assisted laser in situ keratomileusis for correction of high myopia and myopic astigmatism

AIM： To compare and calculate the 3-year refractive results, higher-order aberrations （HOAs）, contrast sensitivity （CS） and dry eye parameters after small incision lenticule extraction （SMILE） and wavefront-guided femtosecond laser-assisted laser in situ keratomileusis （FS-LASIK） for correction of high myopia and myopic astigmatism. METHODS： In this prospective, non-randomized comparative study, 78 eyes with spherical equivalent （SE） of -8.11±1.09 diopters （D） received a SMILE surgery, and 65 eyes with SE of -8.05±1.12 D received a wavefront-guided FS-LASIK surgery with the VisuMax femtosecond laser （Carl Zeiss Meditec, Jena, Germany） for flap cutting. Visual acuity, manifest refraction, CS, HOAs, ocular surface disease index （OSDI） and tear break-up time （TBUT） were evaluated during a 3-year follow-up. RESULTS： The difference of uncorrected distance visual acuity （UDVA） postoperatively was achieved at lmo and at 3mo, whereas the difference of the mean UDVA between two groups at 3y were not statistically significant （t=-1.59, P=-0.13）. The postoperative change of SE was 0.89 D in the FS-LASIK group （t=5.76, P=0.00）, and 0.14 D in the SMILE group （t=-0.54, P=0.59） from lmo to 3y after surgery. At 3-year postoperatively, both HOAs and spherical aberrations in the SMILE group were obviously less than those in the FS-LASIK group （P=0.00）, but the coma root mean square （RMS） was higher in the SMILE group （0.59±0.26） than in the FS-LASIK group （0.29±0.14, P=0.00）. The mesopic CS values between two groups were not statistically significant at 3y postoperatively. Compared with the FS-LASIK group, lower OSDI scores and longer TBUT values were found in the SMILE group at Imo and 3mo postoperatively. With regard to safety, no eye lost any line of CDVA in both groups at 3y after surgery. CONCLUSION： Both SMILE and wavefront-guided FS- LASIK procedures provide good visual outcomes. Both procedures are effective and safe, but SMILE surgery achieve more stable long-term refractive outcome and better control of early postoperative dry eye as compared to FS-LASIK.

Dry eye and corneal sensitivity after small incision lenticule extraction and femtosecond laser-assisted in situ keratomileusis:a Meta-analysis

AIM：To assess the corneal sensitivity and the incidences of dry eye after small incision lenticule extraction（SMILE） and femtosecond laser-assisted in situ keratomileusis（FSLASIK）.METHODS：The Meta-analysis was performed using Rev Man 5.3.We searched on Pub Med from inception to March 2016.Summary weighted mean difference（WMD） and 95% confidence intervals（CIs） were used to analyze the datum.Random-effects or fixed-effects models were chosen up to between-study heterogeneity.The main outcomes were composed of the Ocular Surface Disease Index（OSDI） scores,tear film break-up time（TBUT）,Schirmer Test and corneal sensitivity.RESULTS：Eight eligible studies including 772 eyes（386 in SMILE group and 386 in FS-LASIK group） were identified.The parameters have no significiant difference heterogeneity between SMILE and FS-LASIK group preoperatively.There were significant differences between the two groups in OSDI scores at one and three months postoperatively,in TBUT at one and three months postoperatively,in corneal sensitivity at one week,about one month and three months postoperatively.However,there was no significant difference observed in Schirmer Test at the follow-up periods.CONCLUSION：Compare to FS-LASIK,dry eye and the corneal sensitivity recover better in the SMILE group,in first three months after the surgery.

Small-incision lenticule extraction versus femtosecond lenticule extraction for myopic:a systematic review and Meta-analysis

AIM： To examine differences in efficacy, accuracy, safety, aberrations and corneal biomechanical between Small incision lenticule extraction （SMILE） and femtosecond lenticule extraction （FLEx） for myopia. METHODS： Comprehensive studies were conducted on the PubMed, MEDLINE, EMBASE, and Cochrane Controlled Trials Register before 31 July, 2015. Meta-analyses were performed on the primary outcomes [loss of ≥2 lines of corrected distance visual acuity （CDVA）, uncorrected distance visual acuity （UDVA） ≥20/20, spherical equivalent （SE） within ±0.50 diopters （D）, final refractive SE], secondary outcomes were high-order aberrations （HOAs） and corneal biomechanical [central corneal thickness （CCT）, corneal hysteresis （CH） and corneal resistance factor （CRF）]. RESULTS： Seven trials describing a total of 320 eyes with myopia were included in this Meta-analysis. No significant differences were found in the efficacy [UDVA weighted mean difference （WMD） -0.01; 95%CI： -0.04 to 0.01; P=0.37, UDVA ≥20/20, OR 1.49; 95%CI： 0.78 to 2.86; P=0.23], accuracy （SE WMD -0.03; 95%CI： -0.12 to 0.07; P=0.58 , SE within ±0.5 D OR 1.25; 95%CI： 0.34 to 4.65; P=0.74）, HOAs （WMD -0.04; 95%CI： -0.09 to 0.01; P=0.14） and CCT WMD 1.83; 95%CI： -7.07 to 10.72; P=0.69, CH WMD -0.01; 95%CI： -0.42 to 0.40; P=0.97, CRF WMD 0.17; 95%CI： -0.33 to 0.67; P=0.50） in the last fellow-up. But for safety, FLEx may achieve fewer CDVA lost two or more two lines （OR 11.11; 95%CI： 1.27 to 96.86; P=0.03） than SMILE, however CDVA （WMD 0.00; 95%CI： -0.03 to 0.02; P=0.77） is similar. CONCLUSION： SMILE and FLEx are comparable in terms of both efficacy, accuracy, aberrations and corneal biomechanical measures in the follow-up,but FLEx seems to be better in safety measures. The results should be interpreted cautiously since relevant evidence is still limited, although it is accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed.

Early changes to dry eye and ocular surface after smallincision lenticule extraction for myopia

AIM： To investigate the early changes in dry eye symptoms, tear function and ocular surface following small-incision lenticule extraction（SMILE） for myopia.·METHODS： Ninety-seven consecutive patients（193 eyes）who underwent SMILE for myopia were observed in this longitudinal and retrospective study. Parameters evaluated included： subjective dry eye symptoms（dryness, foreign body sensation and photophobia）, tear film breakup time（TBUT）, Schirmer Ⅰ test without anesthesia（S Ⅰ T）, tear meniscus height（TMH） and corneal fluorescein staining. Each parameter was evaluated before, and subsequently at 1d, 1wk, 1 and3 mo after surgery.·RESULTS： Compared with preoperative data, dryness was noted to be significantly increased at 1wk and 1mo postoperatively（P 〈0.01）. Symptoms of photophobia and foreign body sensation demonstrated significant differences at 1d and 1wk as compared with preoperative scores respectively（P 〈0.01）. These values were decreased at 1 and 3mo post-surgery（P 〉0.05）.Conversely the corneal staining scores were higher than the preoperative data at 1d, 1wk and 1mo（P 〈0.01）, but were close to the preoperative level at 3mo postoperatively. There was a significant decrease in TMH at 1wk and 1mo（P 〈0.01）, but the value was close to the preoperative level at 3mo postoperatively（P =0.16）. The examination outcomes of S Ⅰ T were significantly increased at 1d then reduced at 1wk after surgery（P 〈0.01）. Each value subsequently returned to the baseline value at 1 and 3mo（P 〉0.05）. TBUT was significantly decreased at all postoperative time points（P 〈0.01）.· CONCLUSION： SMILE resulted in mild dry eye symptoms, tear film instability and ocular surface damages; however, these complications can recover in a short period of time.

Simple method of measuring ocular rotation in supine position during small incision lenticule extraction

AIM:To introduce a novel measurement method of static cyclotorsion in small incision lenticule extraction(SMILE)and to investigate the effect of preoperative parameters on cyclotorsion and the effect of cyclotorsion on postoperative outcomes.METHODS:The medical records of 242 patients and 484 eyes who under went SMILE surger y were retrospectively reviewed.Preoperative intraocular pressure,refractive error,and corneal thickness were investigated.Refractive values and visual acuity were measured at 1d,1,3,and 6mo.Ocular cyclotorsion in the supine position was measured by calculating the location and angle of the incision site of the cornea in the anterior slit photograph taken after surgery.RESULTS:Of the total 484 eyes in 242 patients,preopera tive means phericale quivalent(SE)was-4.10±1.64 D,and the mean astigmatism was-0.82±0.74 D.Uncorrected distance visual acuity(UCVA)and SE improved significantly after the surgery.Moreover,219(45.2%)eyes had excyclotorsion,235(48.6%)eyes had incyclotorsion,and 30(6.2%)eyes had no torsion.The right eyes tended to be excyclotorted,and the left eyes tended to be incyclotorted(P<0.01).The mean cyclotorsion was 1.18°±3.69°,and the mean absolute value of cyclotorsion was 3.14°±2.26°.The range of cyclotorsion was 0.5°–11.4°.It was found that the smaller the preoperative sphere,the higher the amount of cyclotorsion(r=0.11,P=0.016).There was no significant association between the amount of cyclotorsion and preoperative astigmatism.There was no correlation between sex,preoperative corneal thickness,preoperative intraocular pressure,amount of cyclotorsion,and direction of cyclotorsion.The ratio of right eye excyclotorsion and left eye incyclotorsion on 1d was higher than that at 1,3,and 6mo(all P<0.01).There was no difference between the 1,3,and 6mo results in the right and left eyes(P=0.15,P=0.16,respectively).CONCLUSION:The newly devised ocular cyclotorsion measurement method can be used to evaluate ocular cyclotorsion after SMILE.Preoperative SE is associated with the amount of cyclotorsion,however,cyclotorsion doesn't have a significant effect on the results of SMILE surgery.

Cap morphology after small-incision lenticule extraction and its effects on intraocular scattering

AIM： To investigate cap morphology after small-incision lenticule extraction （SMILE） and its effects on intraocular scattering. METHODS： Sixty-five eyes of 33 patients undergoing SMILE were enrolled. In addition to regular evaluation, Fourier-domain optical coherence tomography was used to investigate cap thickness at ld, lwk, 1 and 3mo postoperatively. The optical quality including modulation transfer function cutoff frequency, Strehl ratio, Optical Quality Analysis System （OQAS） values, and objective scattering index （OSI）, were evaluated using OQASTM. RESULTS： Cap thickness decreased from ld to lwk （P〈0.001）, but remained higher than intended thickness of 120 μm after 3mo （P〈0.001）. Cap thickness in central area was thinner than that of in the paracentral and peripheral areas （P〈0.0001）. Total number of microdistortions decreased from ld to 3mo （P〈0.0001）. Pearson analysis revealed a weak correlation between OSI and standard deviation of cap thickness at ld and lmo, as well as between range of cap thickness and OSI at 1mo. No correlation was found between microdistortion and OSI, but a negative correlation existed between microdistortion and range at ld and lmoafter surgery. CONCLUSION： The corneal cap tends to be more accurate and regular with time lapse. Better cap morphology tends to contribute less intraocular scattering in the eyes undergoing SMILE.

Repeatability and reproducibility of corneal higher-order aberrations measurements after small incision lenticule extraction using the Scheimpfug-Placido topographer

Background:To evaluate the precision of corneal higher-order aberrations measurements after small incision lenticule extraction(SMILE)using the Sirius Scheimpfug-Placido topographer(CSO,Italy).Methods:Seventy-fve eyes from 75 postoperative subjects were included in this prospective study.Three consecutive corneal aberrometric measurements were obtained with the Scheimpfug-Placido topographer by two experienced operators to assess intra-and inter-observer reproducibility.The within-subject standard deviation(Sw),test-retest repeatability(TRT)and the intraclass correlation coefcient(ICC)were calculated.Results:For intraobserver repeatability of anterior and total corneal aberrations,all ICCs were more than 0.922,except for trefoil(0.722 to 0.768).The ICCs of total root mean square(RMS),coma Z(3,±1),and spherical aberration Z(4,0)were over 0.810 while higher-order RMS,trefoil Z(3,±3),and astigmatism II Z(4,±2)were below 0.634 for posterior corneal surface aberrations.All Sw values for all types of aberrations were equal to or below 0.07μm.Regarding interobserver reproducibility,all TRT values were no more than 0.12μm,0.05μm,and 0.11μm for anterior,posterior,and total corneal aberrations,respectively.The ICC values ranged from 0.875 to 0.989,from 0.686 to 0.976 and over 0.834 for anterior,posterior,and total corneal aberrations,respectively.Conclusions:The repeatability of measurements of anterior and total corneal aberrations with the Sirius system in corneas after SMILE surgery was high,except for trefoil.There was some variability in posterior corneal aberrometric measurements.High reproducibility of corneal aberrometric measurements was observed between measurements of both examiners,except for trefoil,with poor to moderate reproducibility.

Recent advances in small incision lenticule extraction(SMILE)-derived refractive lenticule preservation and clinical reuse

Small incision lenticule extraction(SMILE)has become one of the mainstream refractive surgeries in recent years,with satisfactory efficacy,safety,and predictability.SMILE-derived refractive lenticule,the byproduct of the surgery,holds great potential in clinical practice given its easy access and good biocompatibility.Numerous studies have been published to describe its applications in refractive correction,corneal ectasia diseases,and corneal defects.The feasibility and safety were validated in both animal models and clinical studies.Moreover,the preservation method is also crucial for its further promotion and application.Novel techniques are also evaluated and applied in lenticule preservation.We covered the recent advances in the preservation of corneal stromal lenticules and their clinical reuse in this review.

Applications of SMILE-extracted lenticules in ophthalmology

AIM:To review recent innovations,challenges,and applications of small incision lenticule extraction(SMILE)extracted lenticule for treating ocular disorders.METHODS:A literature review was performed in the PubMed database,which was last updated on 30 December 2021.There was no limit regarding language.The authors evaluated the reference lists of the collected papers to find any relevant research.RESULTS:Due to the simplicity and accuracy of modern femtosecond lasers and the extensive development of SMILE surgery,many healthy human corneal stromal lenticules were extracted during surgery,motivating some professionals to investigate the SMILE lenticule reusability in different ocular disorders.In addition,new approaches had been developed to preserve,modify,and bioengineer the corneal stroma,leading to the optimal use of discarded byproducts such as lenticules from SMILE surgery.The lenticules can be effectively re-implanted into the autologous or allogenic corneas of human subjects to treat refractive errors,corneal ectasia,and corneal perforation and serve as a patch graft for glaucoma drainage devices with better cosmetic outcomes.CONCLUSION:SMILE-extracted lenticules could be a viable alternative to human donor corneal tissue.

Efficacy,predictability and safety of small incision lenticule extraction(SMILE)

Background:The purpose of this case series is to report the one-year outcomes of small incision lenticule extraction(SMILE)using the VisuMax®femtosecond laser.Methods:Two hundred and six patients were recruited for this retrospective,single center study at TRSC International LASIK Center in Bangkok,Thailand.Patients underwent SMILE,whereby an intrastromal lenticule was cut using a femtosecond laser and then manually extracted without the need for flap creation.Outcome measures included refraction,visual acuity and contrast sensitivity evaluation.Patients were treated and followed for one year.Results:SMILE for the correction of low to high myopia was performed on 347 eyes of 206 patients.The mean preoperative spherical equivalent was−4.96±1.88 diopters(D).On the first day following surgery,for eyes with a plano target refraction(99.14%of all eyes),uncorrected distance visual acuity(UDVA)was 20/20 or better in 90%of eyes.At the one week postoperative exam,the mean spherical equivalent was 0.01±0.36 D and UDVA was 20/20 or better in 84%of eyes.After one year follow-up,no eyes showed loss of 2 or more lines of visual acuity and 31%of eyes gained one or more lines.The photopic contrast sensitivity of SMILE treated eyes at 12 and 18 cycles per degree(cpd)improved from 1.59 and 0.94 preoperatively to 1.6 and 0.98,respectively,after one year.Conclusions:In this series,SMILE using the VisuMax®femtosecond laser demonstrated that after one year it is an effective,predictable and safe minimally invasive corneal refractive procedure.

Small incision lenticule extraction(SMILE)in the correction of myopic astigmatism:outcomes and limitations-an update

Small Incision Lenticule Extraction(SMILE)is a flap-free intrastromal technique for the correction of myopia and myopic astigmatism.To date,this technique lacks automated centration and cyclotorsion control,so several concerns have been raised regarding its capability to correct moderate or high levels of astigmatism.The objective of this paper is to review the reported SMILE outcomes for the correction of myopic astigmatism associated with a cylinder over 0.75 D,and its comparison with the outcomes reported with the excimer laser-based corneal refractive surgery techniques.A total of five studies clearly reporting SMILE astigmatic outcomes were identified.SMILE shows acceptable outcomes for the correction of myopic astigmatism,although a general agreement exists about the superiority of the excimer laser-based techniques for low to moderate levels of astigmatism.Manual correction of the static cyclotorsion should be adopted for any SMILE astigmatic correction over 0.75 D.

Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes

This review summarizes the current status of the small incision lenticule extraction(SMILE)procedure.Following the early work by Sekundo et al.and Shah et al.,SMILE has become increasingly popular.The accuracy of the creation of the lenticule with the VisuMax femtosecond laser(Carl Zeiss Meditec)has been verified using very high-frequency(VHF)digital ultrasound and optical coherence tomography(OCT).Visual and refractive outcomes have been shown to be similar to those achieved with laser in situ keratomileusis(LASIK),notably in a large population reported by Hjortdal,Vestergaard et al.Safety in terms of the change in corrected distance visual acuity(CDVA)has also been shown to be similar to LASIK.It was expected that there would be less postoperative dry eye after SMILE compared to LASIK because the anterior stroma is disturbed only by the small incision,meaning that the anterior corneal nerves should be less affected.A number of studies have demonstrated a lower reduction and faster recovery of corneal sensation after SMILE than LASIK.Some studies have also used confocal microscopy to demonstrate a lower decrease in subbasal nerve fiber density after SMILE than LASIK.The potential biomechanical advantages of SMILE have been modeled by Reinstein et al.based on the non-linearity of tensile strength through the stroma.Studies have reported a similar change in Ocular Response Analyzer(Reichert)parameters after SMILE and LASIK,however,these have previously been shown to be unreliable as a representation of corneal biomechanics.Retreatment options after SMILE are discussed.Tissue addition applications of the SMILE procedure are also discussed including the potential for cryo-preservation of the lenticule for later reimplantation(Mohamed-Noriega,Angunawela,Lim et al.),and a new procedure referred to as endokeratophakia in which a myopic SMILE lenticule is implanted into a hyperopic patient(Pradhan et al.).Finally,studies reporting microdistortions in Bowman’s layer and corneal wound healing responses are also described.