Small Incision Lenticule Extraction Procedure Research Articles

Dry eye evaluation and correlation analysis between tear film stability and corneal surface regularity after small incision lenticule extraction

To investigate the dry eye after small incision lenticule extraction (SMILE) and explore the correlations between changes in the tear film stability, the tear secretion and the corneal surface regularity. Sixty-two eyes of 22 men and 13 women who underwent SMILE were included in this study. Corneal topography was measured to assess the index of surface variance (ISV) and the index of vertical asymmetry (IVA). Dry eye tests including subjective symptom questionnaire, tear breakup time (TBUT), corneal fluorescein staining and Schirmer's test (ST) were evaluated before and at 1 and 6months postoperatively. TBUT was found to be significantly decreased from 9.8±3.4s preoperatively to 7.4±3.8s at 1month and 6.5±3.6s at 6months (both P<0.001). There was a significant decrease in ST at 1month postoperatively (P=0.012); however, ST returned to baseline by 6months (P=0.522). Both ISV and IVA significantly increased after the surgery (all P<0.001). In addition, the changes in TBUT were negatively correlated with the increases in ISV and IVA (r=-0.343, P=0.006 and r=-0.311, P=0.014, respectively). Patients undergoing SMILE might develop a short-TBUT type of dry eye. Corneal surface regularity indices might be helpful in the assessment of tear film stability following SMILE procedure.

Ectasia following small-incision lenticule extraction (SMILE): a review of the literature.

PurposeFour cases of corneal ectasia after small-incision lenticule extraction (SMILE) have been reported. In this review, we provide an overview of the published literature on corneal ectasia after SMILE and risk factors associated with this complication.MethodsCase reports were identified by a search of seven electronic databases for pertinent heading terms between 2011 and July 2017. We identified patient characteristics and surgical details including preoperative topography, central corneal thickness, and anterior keratometry (Km). Residual stromal bed (RSB) values not reported were computed using VisuMax ReLEx SMILE software Version 2.10.10. Preoperative ectasia risk was measured using the Randleman Ectasia Risk Score System (ERSS). Percent tissue alteration was calculated for each patient as described by Santhiago et al.ResultsSeven eyes of four patients developed corneal ectasia post SMILE. Two patients had abnormal topography in both eyes. One patient had abnormal topography in one eye. Only one patient was noted to have normal topography in both eyes and later developed ectasia in one eye in the absence of any known risk factors. The mean Randleman ectasia risk score was 4±3 (range: 1–8). The mean calculated percent tissue altered (PTA) was 38%±6% (range: 30%–47%).ConclusionA majority of reported ectasia cases occurred in patients with subclinical keratoconus. These conditions may be exacerbated by SMILE and should be considered absolute contraindications to the procedure. Three patients were identified to have high risk based on the ERSS, and one patient exhibited a PTA ≥40%. We formulated a modification to the current calculation of PTA that takes into account the differences in tissue altered between SMILE and laser in situ keratomileusis (LASIK). More studies are needed to fully quantify the risk of ectasia. For now, we propose adopting the same exclusion criteria used for LASIK in the SMILE procedure until more specific metrics have been validated.

Enhancement After Myopic Small Incision Lenticule Extraction (SMILE) Using Surface Ablation

To report the feasibility and outcomes of surface ablation after small incision lenticule extraction (SMILE). In this retrospective evaluation of 1,963 SMILE procedures, 43 eyes (2.2%) were re-treated at three separate clinics. Of these, 40 eyes of 28 patients with a follow-up of at least 3 months were included in the analysis. During surface ablation, mitomycin C was applied for haze prevention. Spherical equivalent was -6.35 ± 1.31 diopters (D) before SMILE and -0.86 ± 0.43 D before surface ablation. Surface ablation was performed after a mean of 9.82 ± 5.27 months and resulted in a spherical equivalent of 0.03 ± 0.57 D at 3 months (P < .0001). The number of patients within ±0.50 and ±1.00 D of target refraction increased from 22.5% to 80% and from 72.5% to 92.5%, respectively. Mean uncorrected distance visual acuity (UDVA) improved from 0.23 ± 0.20 to 0.08 ± 0.15 logMAR (P < .0001); 65% of patients gained at least one line. Corrected distance visual acuity (CDVA) remained unchanged with 0.01 ± 0.07 logMAR before versus -0.01 ± 0.05 logMAR after re-treatment (P = .99). Six eyes (15.0%) lost one line of CDVA, but final CDVA was 0.00 logMAR in four and 0.10 logMAR in two of these cases. The safety and efficacy indices were 1.06 and 0.90 at 3 months, respectively. Three of the four surface ablation profiles (Triple-A, tissue-saving algorithm, and topography-guided) resulted in equally good results, whereas enhancement with the aspherically optimized profile (ASA), used in two eyes, resulted in overcorrection (+1.38 and +1.75 D). Combined with the intraoperative application of mitomycin C, surface ablation seems to be a safe and effective method of secondary enhancement after SMILE. Due to the usually low residual myopia, the ASA profile is not recommended in these cases. [J Refract Surg. 2017;33(8):513-518.].

Risk profiles of ectasia after keratorefractive surgery.

To identify and evaluate the risk factors of iatrogenic ectasia after refractive surgery. We reviewed recently published papers that identified various risk factors associated with ectasia after LASIK, photorefractive keratectomy, small incision lenticule extraction, and other refractive surgical procedures. We also attempted to evaluate the relative contributions of these factors to the development of ectasia following refractive surgery. Forme fruste keratoconus, genetic predisposition to keratoconus, low residual stromal bed thickness (through high myopia, thin preoperative cornea, or thick LASIK flap), and irregular corneal topography have been identified as risk factors for keratectasia development after refractive surgical procedures. A newly proposed metric, percentage tissue altered, has been reported to be a robust indicator for post LASIK ectasia risk calculation. Several cases of keratectasia have also been reported 6 to 12 months following minimally invasive small incision lenticule extraction procedure. Other risk factors associated with iatrogenic ectasia include eye rubbing, young age, and pregnancy. Ectasia after refractive surgery is a relatively rare complication which can lead to sight-threatening complications if not detected and treated in time. It is important to continue our quest to improve our methods of identifying absolute and relative risk factors of ectasia and their cut-off values following various keratorefractive surgical procedures.

Visual outcomes after balanced salt solution infiltration during lenticule separation in small-incision lenticule extraction for myopic astigmatism.

To evaluate the refractive outcomes of balanced salt solution infiltration during small-incision lenticule extraction (SMILE).This randomized prospective study enrolled 52 patients (104 eyes) with myopic astigmatism. Patients underwent SMILE to correct the myopic astigmatism in Daping Hospital of the Third Military Medical University between January and July 2013. One eye of each patient received traditional SMILE (control group) and the other received a modified SMILE procedure (liquid infiltration group). The corrected distance visual acuity (CDVA), postoperative uncorrected distance visual acuity (UDVA), refraction, wavefront aberration, intraocular pressure (IOP), modulation transfer function (MTF) cut-off frequency, and objective scattering index (OSI) were evaluated.UDVA in the liquid infiltration group was significantly higher than that in the control group at 1 day postoperatively, but not at 1 month after surgery. Moreover, OSI and MTF cut-off frequency in the liquid infiltration group were higher than those in the control group at early follow-up. However, no significant intergroup difference was observed in the OSI and MTF cut-off frequency at 3 months after surgery. In addition, the predictability was better in the liquid infiltration group than in the control group. The changes of horizontal coma in the liquid infiltration group were lesser than those in the control group. However, no intergroup difference was observed in the reduction of IOP at 1 month after surgery.The modified SMILE procedure results in better visual outcomes than did the traditional SMILE procedure when used for treating myopic astigmatism.

Comparison of corneal ablation depth predictability between small incision lenticule extraction and femtosecond laser-assisted in situ keratomileusis for myopia

Background Recently, small incision lenticule extraction (SMILE) procedure is used to correct myopia.The clinical safety and efficiency of SMILE have been approved, but its predictability to corneal ablation depth is brought into focus. Objective This study was to compare the predictability of ablation depth in central cornea between SMILE and femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for myopia. Methods A non-randomized controlled clinical study was performed.Two hundred and seventy eyes of 135 myopic patients who were going to receive corneal refractive surgery were included in Beijing Tongren Hospital from October 2015 to May 2016.SMILE and FS-LASIK were performed on 138 eyes of 69 patients and 132 eyes of 66 patients matched in demography respectively under the informed consent.Central corneal thickness was measured by RTVue FD-OCT before and 1 week after surgery.The refractive power, actual ablation depth (difference of central corneal thickness before and after surgery) and central corneal cutting error (difference between theoretically expected ablation depth and real ablation depth) were intergrouply compared, and the correlation of real ablation depth with theoretically expected ablation depth was assessed. Results No significant difference was found in spherical power, astigmatic power and spherical equivalent after surgery between SMILE group and FS-LASIK group (t=-1.826, -1.405, -1.420, all at P>0.05). The actual ablation depth was (76.96±15.27)μm in the SMILE group, which was significant lower than (96.76±16.52)μm of theoretically expected ablation depth (t=-23.016, P<0.01); however, there was no significant difference in the FS-LASIK group between actual and expected ablation depth([77.92±18.69] μm versus [77.42±15.60] μm) (t=-0.604, P=0.547). The central corneal cutting error was (20.55±8.51)μm in the SMILE group and (7.17±5.97)μm in the FS-LASIK group, showing a significant difference between them (t=14.950, P<0.01). The positive linear correlations were seen between actual and expected ablation depth in both SMILE group and FS-LASIK group (r=0.799, 0.867, both at P<0.01). The actual ablation depth was increased over expected ablation depth, with the regression equations of Y=3.892+ 0.749X in the SMILE group and Y=3.443+ 0.957X in the FS-LASIK group. Conclusions The actual corneal ablation depth is less than expected corneal ablation depth in SMILE procedure, while in FS-LASIK procedure, the actual corneal ablation depth appears to be consistent with the expected one, inferring a good predictability in corneal ablation depth in FS-LASIK surgery. Key words: Myopia/surgery; Corneal stroma/surgery; Lasers, excimer/therapeutic use; Central corneal thickness; Ablated depth; Predictability; Comparative study

Biomechanical Differences Between Femtosecond Lenticule Extraction (FLEx) and Small Incision Lenticule Extraction (SmILE) Tested by 2D-Extensometry in Ex Vivo Porcine Eyes.

To evaluate the biomechanical stability of ex vivo porcine corneas after femtosecond lenticule extraction (FLEx) and small incision lenticule extraction (SmILE) refractive surgeries. Forty-five porcine eyes were equally divided into three groups: Groups 1 and 2 were treated with FLEx and SmILE procedure, respectively. Group 3 served as control. A refractive correction of -14 diopters (D) with a 7-mm zone using either a 160-μm flap (FLEx) or a 160-μm cap (SmILE) was performed. For two-dimensional (2D) elastic and viscoelastic biomechanical characterization, two testing cycles (preconditioning stress-strain curve from 1.27 to 12.5 N, stress-relaxation at 12.5 N during 120 seconds) were conducted. Young's modulus and Prony constants were calculated. At 0.8% of strain, FLEx (370 ± 36 kPa) could resist a significantly lower stress than SmILE (392 ± 19 kPa, P = 0.046) and the control group (402 ± 30 kPa, P = 0.013). Also, FLEx (46.1 ± 4.5 MPa) had a significantly lower Young's modulus than the control group (50.2 ± 3.4 MPa, P = 0.008). The Young's modulus of SmILE (48.6 ± 2.5 MPa) had values situated between untreated corneas and FLEx-treated corneas. When compared to untreated controls, the stress resistance decreased by 8.0% with FLEx and 2.5% with SmILE; Young's modulus decreased by 5.1% with FLEx and 1.04% with SmILE. With a cap-based procedure, both anterior cap and stromal bed carry the intraocular pressure, while in a flap-based procedure, only the stromal bed does. Compared to flap-based procedures like FLEx, the cap-based technique SmILE can be considered superior in terms of biomechanical stability, when measured experimentally in ex vivo porcine corneas.

Corneal densitometry changes in a patient with interface fluid syndrome after small incision lenticule extraction

BackgroundTo report a case of interface fluid syndrome (IFS) following small incision lenticule extraction (SMILE) evaluated with corneal densitometry and optical coherence tomography (OCT).Case presentationAn 18-year-old man reported sudden vision loss 24 days after SMILE procedure. Intraocular pressure (IOP) was 36.3 mmHg (OD) and 36.7 mmHg (OS) by noncontact tonometry. Moderate corneal edema, interface fluid pocket and haze were observed by OCT and confirmed by corneal densitometry values. Discontinuation of steroids and addition of hypotensive medication were offered immediately. The symptoms were cured after the medication. Changes of corneal densitometry were consistent with the clinical course of IFS.ConclusionThis case illustrates that it is crucial to be aware that a history of SMILE can also cause IFS. Both OCT and corneal densitometry can serve as auxiliary means to evaluate the clinical course of IFS, and appropriate IOP management is an effective approach.

Enhancement after Small-Incision Lenticule Extraction: Incidence, Risk Factors, and Outcomes

To report the incidence, risk factors, and outcomes of enhancement after small-incision lenticule extraction (SMILE). Retrospective cohort study. Five hundred twenty-four eyes of 307 patients who underwent SMILE at Singapore National Eye Center between February 2012 and March2016. The data collected included patient age at primary SMILE, gender, race, preoperative and postoperative manifest refraction spherical equivalent (MRSE), preoperative and postoperative uncorrected distance visual acuity and corrected distance visual acuity, the occurrence of suction loss during the procedure, and the need for enhancement. All enhancements were carried out by performing an alcohol-assisted photorefractive keratectomy (PRK) procedure with application of mitomycin C (MMC). Incidence, prevalence, preoperative and intraoperative risk factors for enhancement, and outcomes after enhancement. The prevalence of enhancement was 2.7%, and 71.4% eyes had enhancement within 1 year of primary SMILE. The incidence of enhancement was 2.1% and 2.9% at 1 and 2 years, respectively. Age older than 35 years, preoperative MRSE more than-6.00 diopters (D), preoperative myopia more than 6.00 D, preoperative astigmatism more than 3.00 D, and intraoperative suction loss were significant risk factors for enhancement after SMILE after adjusting for all other covariates (odds ratios, 5.58, 4.80, 1.41, 3.06, and 2.14, respectively; P= 0.004, 0.021, 0.022, 0.002, and 0.020, respectively). In the patients who underwent bilateral SMILE, the first-operated eye had a marginal trend toward significance for enhancement (P= 0.054). There was no gender or racial difference. In the 14 eyes requiring enhancement, the uncorrected distance visual acuity before enhancement ranged from 20/80 to 20/25, and the mean attempted enhancement spherical equivalent was-0.50±0.86 D. The uncorrected distance visual acuity improved in most patients (92.9%) after enhancement. The 2-year incidence of enhancement after SMILE was 2.9%. Risk factors associated with enhancement included older age at SMILE procedure, greater preoperative MRSE, greater preoperative myopia, greater preoperative astigmatism, and the occurrence of intraoperative suction loss. Clinical outcomes of using PRK with application of MMC for enhancement were good.

Effect of optical zone diameter on corneal biomechanical properties after small incision lenticule extraction

Objective: To investigate the effect of optical zone diameter on corneal biomechanical properties after small incision lenticule extraction (SMILE). Methods: In this prospective case-control study, 62 eyes of 42 patients with myopia and myopic astigmatism that had undergone SMILE procedure were divided into 2 groups according to the optical zone (OZ) diameter: group A, 31 eyes of 19 patients, OZ= 6.5 mm; group B, 31eyes of 23 patients, OZ=6.0 mm. These patients were examined for corneal hysteresis (CH) and corneal resistance factor (CRF) with the Ocular Response Analyzer (ORA) preoperatively and at 1 week, 1 month and 3 months postoperatively; at the same time, the central corneal thickness-corrected indices of DifCH and DifCRF were calculated. Pearson correlation was applied to analyze the correlation between CH and CRF and central corneal thickness. Independent-samples t test was utilized to compare CH and CRF between the two groups. Repeated ANOVA was used to compare the difference of corneal biomechanical properties at different follow-up timepoints. Results: The preoperative mean CRF and CH values were (10.13±1.19) mmHg and (9.65±1.12) mmHg in group A and (10.34±0.89) mmHg and (10.04± 1.05) mmHg in group B, respectively, and no significant differences were found in CRF and CH between the two groups (CRF: t=-0.807, P=0.423. CH: t=-1.405, P=0.165). The mean CRF values in group A at postoperative 1 week and 3 months were (6.62 ± 1.09) mmHg and (6.83 ± 1.07) mmHg, respectively, which were significantly lower than the relevant mean CRF values in group B (t=-2.703, P=0.009. t=-3.733, P= 0.001). Meanwhile, the mean CH values at 1 week, 1 month and 3 months postoperatively in group A were (7.31±1.06) mmHg, (7.37±0.96) mmHg and (7.82±0.97) mmHg, respectively, which were significantly lower than those in group B (t=-2.415, P=0.019. t=-2.113, P=0.039. t=-2.67, P=0.01). Moreover, the DifCRF and DifCH values in group A were significantly lower than those in group B at 3 months postoperatively (t=-3.409, P=0.001. t=-2.064, P=0.044). The CRF and CH values in both groups showed a significant reduction at 1 week, 1 month and 3 months postoperatively (P<0.05). Conclusions: The size of optical zone has some effects on corneal biomechanical properties after SMILE. The smaller optical zone diameter has a relatively smaller effect. (Chin J Ophthalmol, 2017, 53:182-187).

Small Incision Lenticule Extraction (SMILE) for Hyperopia: Optical Zone Centration.

To evaluate optical zone centration of hyperopic small incision lenticule extraction (SMILE). This prospective study of 60 consecutive hyperopic SMILE procedures used the VisuMax femtosecond laser and matched LASIK procedures with the VisuMax and MEL 80 excimer lasers (Carl Zeiss Meditec AG, Jena, Germany). Inclusion criteria were maximum attempted hyperopic meridian of between +1.00 and +7.00 diopters (D) and astigmatism up to 6.00 D. For SMILE, the optical zone was between 6.3 and 6.7 mm, with a 2-mm transition zone. Two LASIK control groups (6.5- and 7-mm optical zone) were generated matched for spherical equivalent treated. In SMILE, the corneal vertex of the coaxially fixating eye was aligned with the vertex of the curved contact glass. In LASIK, the treatment was centered on the coaxially sighted corneal light reflex (first Purkinje image) with the contralateral eye (Seiler method). A tangential (instantaneous) curvature preoperative to 3 months postoperative difference map was generated for each eye. A fixed grid and set of concentric circles were superimposed on the difference map to measure the offset between the optical zone center and corneal vertex (0,0), and vector analysis was used for comparative analysis. Mean attempted spherical equivalent was +5.61 ± 0.96 D (range: +3.20 to +6.50 D) and mean cylinder was -0.96 ± 0.62 D (range: 0.00 to -2.75 D) in the SMILE group. Mean age was 29 ± 7 years (range: 19 to 52 years) in the SMILE group. Mean centration offset was 0.23 ± 0.15 mm (range: 0 to 0.61 mm) for the SMILE group, 0.33 ± 0.14 mm (range: 0.14 to 0.85 mm) for the 6.5-mm LASIK group, and 0.31 ± 0.19 mm (range: 0.05 to 0.85 mm) for the 7-mm LASIK group. The mean centration offset for SMILE was less than that of both LASIK groups (P < .05). Optical zone centration of hyperopic SMILE was found to be similar to eye-tracker-centered hyperopic LASIK with the MEL 80 laser. [J Refract Surg. 2017;33(3):150-156.].

Assessment of corneal optical quality following small incision lenticule extraction for myopia

Background The current evaluation of corneal optical quality after small incision lenticule extraction (SMILE) is based on the single factor, such as scattering, diffraction or aberration, and all of them are not comprehensive and objective methods.Modulation transfer function (MTF) and Strehl ratio (ST) are novel parameters of corneal optical quality, which can be used to assess the optical quality comprehensively. Objective This study was to evaluate the change of MTF and SR under the photopic and scotopic environment (3 mm and 6 mm pupil size, respectively) after SMILE procedure. Methods The study protocol was approved by Ethic Committee of Tianjin Eye Hospital, and written informed consent was obtained from each patient before any medical procedure.A series cases-observational study with self-control design was carried out.Sixty-three eyes of 32 myopia or myopic astigmatism patients who underwent SMILE surgery in Tianjin Eye Hospital were included from December 2013 to March 2014.The uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA) (LogMAR), the effective index (postoperative UCVA/preoperative BCVA) and refractive diopter were examined, and the MTF, SR and root mean square (RMS) on the anterior corneal surface were measured under the 3 mm and 6 mm pupil size at different spatial frequencies (10, 20, 30, 40, 50 and 60 c/d) by Sirius anterior analyzer before surgery and 1 week, 1 month and 3 months after surgery, respectively. Results UCVA was ≥0.8 in 59, 62 and 63 eyes in 1 week, 1 month and 3 months after SMILE, with the percentage of 93.65%, 98.41% and 100%, and the effective index was 1.104±0.128, 1.126±0.145 and 1.158±0.208, respectively.The refractive diopter was normal in the eyes at postoperative 3 months.The MTFs of various spatial frequencies on the vertical and horizontal meridian under the 3 mm pupil size after SMILE were significantly higher than those before SMILE, while under the 6 mm pupil size, the MTFs were higher only on vertical meridian and 10, 20, 30 and 40 c/d, and there were not significant differences on the horizontal meridian (all at P<0.05). The SRs under the 3 mm and 6 mm pupil size showed increasing softly after surgery in comparison with before surgery, and the SRs were higher under the 3 mm pupil size than those under the 6 mm pupil size at various time points (all at P<0.05). There were not significant differences in RMS among different time points under both 3 mm pupil size and 6 mm pupil size (3 mm pupil size: F=1.348, P=0.184; 6 mm pupil size: F=1.990, P=0.137). Conclusions SMILE provides a great improvement in corneal optical quality for myopia or myopic astigmatism patients, which is more distinct in photopic condition than that in scotopic condition. Key words: Optical quality, corneal; Cornea surgery, laser; Lasers, excimer/therapeutic use; Myopia; Modulation transfer function; Strehl ratio; Small incision lenticule extraction

Corneal Lenticule Allotransplantation After Femtosecond Laser Small Incision Lenticule Extraction in Rabbits.

To investigate the feasibility of allotransplanting extracted lenticules after femtosecond laser-assisted small incision lenticule extraction (SMILE) in rabbits and the subsequent healing process. Fourteen New Zealand white rabbits were divided evenly into 2 groups. The rabbits in group A received SMILE procedures with a -6.00 D correction. The lenticules from group A were immediately inserted into a femtosecond laser-created corneal stromal pocket in group B. After surgery, the anterior segment was assessed in vivo by slit-lamp microscopy, corneal topography, optical coherence tomography, and confocal microscopy. All eyes were enucleated for hematoxylin-eosin staining and transmission electron microscopy after the animals were killed. At postoperative day 1, there was moderate corneal edema in the implanted lenticule stroma. At 6 months, the lenticules were integrated with the surrounding tissue, and the boundary could not be identified through slit-lamp microscopy; regenerated branches of the corneal nerves were thicker than at postoperative month 1 as observed through confocal microscopy. The central corneal thickness increased by 58.75 ± 21.58 μm. The lenticules were gradually integrated with the surrounding tissue, and their density was similar to the adjacent tissue according to optical coherence tomography; however, a clear boundary between the lenticule and surrounding tissue was detectable using light microscopy and transmission electron microscopy, revealing disordered fibers and decreased keratocytes in implanted lenticules. In this model it is feasible and safe to allotransplant extracted corneal lenticules after SMILE. Healing of implanted lenticules after SMILE is stable at postoperative 6 months, but collagen fiber rearrangement requires further investigation.

Small Incision Lenticule Extraction for Correction of Myopia and Myopic Astigmatism: First 24-Hour Outcomes.

Purpose To observe the first 24-hour (h) outcomes of the small incision lenticule extraction procedure (SMILE) for myopia and myopic astigmatism. Methods Fifty-three eyes (27 patients) scheduled for SMILE were followed immediately (0 h), 2, 4, 6, and 24 h after SMILE. Uncorrected visual acuity (UCVA), conjunctival congestion, pain level, and corneal edema, thickness, and densitometry were recorded. Results At 2 h after SMILE, 15.1% of eyes had ≤0.1 LogMAR UCVA; this increased to 62.3%, 98.1%, and 100% at 4, 6, and 24 h, respectively. Some eyes (33.96%) had mild corneal edema immediately after surgery. No 6 h postoperative edema was observed. In the first 24 h after SMILE, corneal thickness gradually decreased. Postoperative corneal densitometry values were significantly higher than preoperative values but gradually decreased during the first postoperative 24 h. Conclusions In the first postoperative 24 h, UCVA and corneal status (edema and densitometry) improved quickly.

Dry Eye After Small Incision Lenticule Extraction and Femtosecond Laser-Assisted LASIK: Meta-Analysis.

To compare postoperative ocular surface integrity and innervation between small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK). The Cochrane Central Register of Controlled Trials, PubMED, and EMBASE were searched for prospective comparative studies. Trials meeting the selection criteria were quality appraised, and the data were extracted by 2 independent authors. The weighted mean differences (WMDs) and 95% confidence intervals (CIs) were used to compare dry eye examinations and corneal subbasal nerve density (SMILE-FS-LASIK). The study covered 5 trials. No significant difference was found in the Schirmer test score between both groups (WMD = -1.91 and 0.27; 95% CI, -5.02 to 1.20 and -0.99 to 1.54; P = 0.23 and 0.67 at 1- and 6-month follow-ups, respectively). Tear breakup time in the SMILE group significantly exceeded that in the FS-LASIK group (WMD = 0.65 and 1.14; 95% CI, 0.20-1.10 and 0.18-2.10; P = 0.004 and 0.02, at 1- and 6-month follow-ups, respectively). Ocular surface disease index scores were significantly better in the SMILE group 6 months postoperatively (WMD = -10.12, 95% CI, -16.07 to -4.18, P = 0.0008). No significant difference was found in tear osmolarity between both groups (WMD = -5.19 and -6.37; 95% CI, -17.15 to 6.76 and -22.74 to 10.00; P = 0.39 and 0.45 at 1- and 6-month follow-ups, respectively). Higher corneal sensitivity was observed in the SMILE group 1 and 6 months postoperatively (WMD = 11.35 and 3.49; 95% CI, 7.29-15.40 and 1.76-5.21; P < 0.00001 and <0.0001, at 1- and 6-month follow-ups, respectively). Corneal subbasal nerve density was also significantly higher in SMILE-treated eyes than it was in FS-LASIK-treated eyes 1 month postoperatively (WMD = 4.72, 95% CI, 1.10-8.34, P = 0.01). According to this meta-analysis, the SMILE procedure has fewer negative impacts on the ocular surface and corneal innervation than does FS-LASIK. Furthermore, SMILE shows superiority over FS-LASIK by a exhibiting a lower risk of postoperative dry eye.

In Vivo and Ex Vivo Evaluation of Inflammation and Apoptosis Induced after SMILE Procedures for Different Refractive Error Range

ABSTRACTPurpose: To detect corneal inflammation and apoptosis induced after small incision lenticule extraction (SMILE) at different refractive corrections for moderate to high values of myopia.Methods: Fifty patients (50 eyes) suffering from medium to high myopia (spherical equivalent refraction from −3.75 to −10.00 diopters (D) with refractive astigmatism under −0.75 D) underwent SMILE in order to correct myopic error. In vivo evaluation was done by corneal confocal microscopy (IVCM) and ex vivo by immunohistochemistry. After surgery, all corneal lenticules were checked for regularity, entirety, and fixed in formalin for immunohistochemistry evaluation of apoptosis (TUNEL) and inflammation (CD11b) levels. Postoperative assessments took place during the first week and the first and third months after surgery. Patients returned for IVCM examination for analysis of the corneal stromal femtosecond laser treatment interfaces reflectivity.Results: No correlation was observed between treated myopic refractive error and number of CD11b+ and TUNEL+ cell in all analyzed extracted lenticules. IVCM at 1 week and 1 month of follow-up showed numerous reflective particles at the laser treatment interface with a moderate light scattering. In semi-quantitative analysis of reflectivity intensity at the laser interfaces, a statistical difference was evident only between 1 week and 1 month (p = 0.0213).Conclusions: SMILE, as an innovative all-femto surgical procedure, results in a reduced tissue inflammation and apoptosis levels with a minimum tissue response, in terms of interface reflectivity, and there are no statistically significant differences among variable treated refractive error range.

Using Donor Lenticules Obtained Through SMILE for an Epikeratophakia Technique Combined With Phototherapeutic Keratectomy.

To investigate the feasibility, safety, and efficacy of using a donor lenticule created during small incision lenticule extraction (SMILE) in an epikeratophakia technique combined with phototherapeutic keratectomy (PTK). Six patients with decreased visual acuity due to a recurrence of corneal dystrophy were included in this prospective pilot study. PTK was performed using the MEL 80 excimer laser (Carl Zeiss Meditec, Jena, Germany) followed by the transplantation of donor lenticules onto the recipient eyes. These lenticules were extracted during SMILE procedures using the VisuMax femtosecond laser (Carl Zeiss Meditec) on 6 donors with myopia and served as the epikeratophakia tissue. The surgeries and postoperative follow-up examinations were uneventful and no complications were noted over 6 months of follow-up. The epithelium remodelling was achieved within 1 month. At the last measurement, the corrected distance visual acuity of all recipient eyes gained at least two lines. Five eyes (83.3%) gained at least two lines of uncorrected distance visual acuity compared to their preoperative levels. Mean keratometric power increased by 5.97 ± 3.73 diopters and central corneal thickness increased by 55.25 ± 36.38 µm. The epithelium healed and the lenticules remained clear over the follow-up period as observed under slit-lamp examination. Anterior segment optical coherence tomography observation showed the lenticule was transparent with a visible demarcation line during the follow-up examination. The use of a SMILE lenticule as a donor lenticule for an epikeratophakia technique appears feasible and safe in the short term. The predictability and long-term effects need further investigation. [J Refract Surg. 2016;32(12):840-845.].

Changes in intraocular pressure values measured with noncontact tonometer (NCT), ocular response analyzer (ORA) and corvis scheimpflug technology tonometer (CST) in the early phase after small incision lenticule extraction (SMILE).

BackgroundCorneal biomechanical properties are always compromised after corneal refractive surgeries thus leading to underestimated intraocular pressure (IOP) that complicates the management of IOP. We investigated the changes in postoperative baseline of IOP values measured with noncontact tonometer (NCT), ocular response analyzer (ORA) and corvis scheimpflug technology (CST) in the early phase after small incision lenticule extraction (SMILE).MethodsTwenty-two eyes (−6.76 ± 1.39D) of 22 moderate and high myopes, (28.36 ± 7.14 years, 12 male and 10 female) were involved in this prospective study. IOP values were measured using a non-contact tomometer (NCT-IOP), an ocular response analyzer (corneal-compensated IOP, IOPcc and Goldmann-correlated IOP, IOPg) and a Corvis scheimpflug technology tonometer (CST-IOP) preoperatively, at 20 min and 24 h, postoperatively. Repeated measures analysis of variance (RM-ANOVA), Pearson’s correlation analysis and multiple linear regression models (stepwise) were performed. Cut-off P values were 0.05.ResultsExcept for IOPcc, NCT-IOP, IOPg, and CST-IOP values significantly decreased after SMILE procedure (All P values <0.05). ΔCCT, as well as ΔMRSE and ΔKm, did not significantly correlated with ΔNCT-IOP, ΔIOPcc, ΔIOPg or ΔCST-IOP, (all P values >0.05). Multiple linear regression models (stepwise) showed that the practical post-operative IOP value was the main predictor of the theoretical post-operative NCT-IOP, IOPcc and IOPg values (all P values <0.001). The postoperative applanation time 1 (AT1) value (B = 8.079, t = 4.866, P < 0.001), preoperative central corneal thickness (CCT) value (B = 0.035, t = 2.732, P = 0.014) and postoperative peak distance (PD) value (B = 0.515, t = 2.176, P = 0.043) were the main predictors of the theoretical post-operative CST-IOP value.ConclusionsIOP values are underestimated when assessed after SMILE by using NCT-IOP, IOPg and CST-IOP. The practical postoperative IOPcc value and theoretical post-operative CST-IOP value may be more preferable for IOP assessment in the early phase after SMILE.Trial registrationCurrent Controlled Trials ChiCTRONRC13003114. Retrospectively registered 17 March 2013

A Pilot Study of SMILE for Hyperopia: Corneal Morphology and Surface Characteristics of Concave Lenticules in Human Donor Eyes.

To evaluate the corneal morphology and surface characteristics of concave lenticules after small incision lenticule extraction (SMILE) for hyperopia. SMILE procedures were performed on two human autopsy corneas in vitro to correct +4.00 diopters of hyperopia. Slit-lamp microscopy and anterior optical coherence tomography (OCT) were performed after lenticule creation and extraction. The extracted lenticules and modified corneas were sent for transmission electron microscopy imaging. Interlamellar gas bubbles were detected at 3 minutes and almost burst at 30 minutes after lenticule creation. A few interlamellar bubbles were detected after lenticule extraction. There was an obvious interlamellar concave gap under OCT. Transmission electron microscopy showed the front and back surfaces of the lenticules were smooth, with some tissue bridges, cavities, and grooves. A good quality concave lenticule can be created via SMILE for hyperopia. The impact of interlamellar gap on visual quality needs further investigation. [J Refract Surg. 2016;32(10):713-716.].

Impact of Suction Loss During Small Incision Lenticule Extraction (SMILE).

To evaluate the clinical results of suction loss in eyes during small incision lenticule extraction (SMILE). This prospective paired-eye case study enrolled 8,490 eyes of 4,296 patients, of which 35 eyes experienced suction loss during the SMILE procedure while being treated for myopia or myopic astigmatism. The eyes with suction loss were re-treated with SMILE, femtosecond laser-assisted LASIK (FS-LASIK), or pseudo SMILE, and the fellow eyes were treated with SMILE. Patients were examined before surgery and at 1 day, 1 week, and 1 and 3 months postoperatively. Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), manifest refraction, higher order aberrations (HOAs), and morphologic modifications of corneal architecture were evaluated. At 3 months, patients were asked if they preferred the vision in either eye. High-contrast CDVA was worse in the eyes that suffered loss of suction than in the fellow eyes at 1 week postoperatively (two-tailed paired t tests, P = .04), but not at 1 and 3 months. There was no statistical significance between the two treatments in the safety and efficacy indices or the 3rd and 4th order aberrations at 3 months postoperatively (two-tailed paired t tests, all P > .05). No apparent abnormalities were observed in the corneas by frequency-domain optical coherence tomography. Re-treatment with femtosecond laser for incomplete SMILE was safe, predictable, and effective, and the patients did not perceive a difference in vision. [J Refract Surg. 2016;32(10):686-692.].