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Suphi Taneri, MD
Anika Rost, MSc
Caroline Hansson, MSc
Samuel Arba Mosquera, PhD
H. Burkhard Dick, MD, PhD
To compare the effect of SMILE cap-thickness in myopic and myopic-astigmatic eyes
Contralateral consecutive case series. Inclusion criteria: myopic and myopic astigmatic bilateral SMILE-treatment with either 100 µm or 120 µm cap thickness. Sidecut, lenticule diameter, lenticule sidecut, laser spot spacing, and pulse energy were identical in contralateral eyes. Target refraction was emmetropia in all cases. Comparison of refractive outcomes, visual acuity, and adverse events at 3 months.
Fifty-one patients were included. At 3 months, mean spherical equivalent refraction was 0.01+/-0.3 D (range: -0.5 to +0.75 D) for 100µm and -0.05+/-0.31 D (range: -1 to +0.75 D) for 120µm. Mean cylinder was -0.25+/-0.26D (range: 0 to -1 D) and -0.3+/-0.27 D (range: 0 to -1 D) for 100µm and 120µm, respectively. Mean uncorrected distance visual acuity (UDVA) was 1.08 (decimal scale) and 1.1 for 100µm and 120µm, respectively. Mean efficacy index was 0.81 and 0.8 for 100µm and 120µm, respectively. Mean safety index was 0.91 and 0.91 for 100µm and 120µm respectively.
We found equally good visual and refractive outcomes with either 100 µm or 120 µm cap-thickness.
Arulmozhi Varman, MD
Aadithreya Varman, MBBS
This study aims at comparison of Higher Order Aberrations pre operatively and post operatively 1 month after SMILE. SMILE has widely replaced conventional refractive procedures because of its superior advantages of small incision size, lesser damage to corneal nerves, faster recovery and no flap related complications.
A retrospective study was conducted on 106 eyes that underwent SMILE over past 1 year. All patients who were above the age of 18 to 32 years with myopia and myopic astigmatism, adequate CCT, stable refractive error, normal corneal topography and normal retinal morphology were included in the study. All procedures were performed by a single surgeon. VisuMax laser system (Carl Zeiss Meditec AG, Jena, Germany) was utilized for the refractive procedures. All patients were evaluated immediately post operatively, post op day 1, post op day 8 and post op day 30. In all visits, patients were evaluated for Post op refractive outcome, UCVA and aberrometry estimated with iTrace aberrometer.
All patients were subjected to UCVA, Post Op Refraction and iTrace aberrometry on day 1, day 10 and day 30. iTrace aberrometry values were compared for Higher Order Aberrations before and after SMILE on day 30. In individuals with spherocylindrical refractive errors Mean higher order aberration was significantly (P<0.05) reduced post operatively. The mean± SD difference was 124.1 ± 103.7. and the 95% CI of the difference was (83.9 – 164.3.) In pure cylinder group Mean higher order aberration was significantly (P<0.05) reduced post op. The mean ± SD difference was 123.8 ± 70.0 and the 95% CI of the difference was (108.1 – 130.7). All analyses were performed with the paired T test.
In our study we have noticed good recovery of visual acuity and lesser HOA in all patients post operatively. This is probably due to lesser energy used and also meticulous surgical handling of the tissues and flap. SMILE is safe and effective procedure for correction of refractive errors and also beneficial in reducing higher order aberration.
Edward E. Manche, MD
Gabriel S. Valerio, MD, ABO
To prospectively compare outcomes between wavefront-guided LASIK and SMILE surgery in the treatment of myopia with and without astigmtism. Outcome measures include high contrast snellen acuity, low contrast snellen acuity (5 and 25%), safety, predictability, efficacy and higher order aberration analysis.
80 eyes of 40 consecutive patients underwent SMILE surgery in one eye and LASIK in their fellow eye. Eyes were randomized according to ocular dominance. The mean pre-operative spherical equivalent refraction was -3.37 +/-1.98 diopters and -3.48 +/- 1.94 diopters in the wavefront-guided group and SMILE group respectively (p = 0.93).
At post-op month 12, mean spherical equivalent refraction was -0.11 +/- 0.27 diopters in the LASIK group and -0.13 +/- 0.53 diopters in the SMILE group (p = 0.73). At post-op month 12, 92% and 83% of eyes had an UDVA of 20/20 in the LASIK and SMILE groups respectively. Seventy-five percent of eyes had an UDVA of 20/16 in both groups. Fifty-eight and 17% of eyes had an UDVA of 20/12.5 in the LASIK and SMILE groups respectively. Eighty and 10% of eyes gained one or more lines of corrected distance visual acuity in the LASIK and SMILE groups respectively (p = 0.05). There were no significant differences in the induction of higher order aberrations between the two groups.
Wavefront-guided LASIK and SMILE have similar clinical outcomes with excellent safety, efficacy and predictability in both groups. LASIK has faster recovery of uncorrected visual acuity compared to SMILE surgery.
Mitra Nejad, MD
David R Hamilton, MD, MS, FACS
To compare uncorrected visual acuities (UDVA) and induced higher order aberrations (HOAs) in the early post-operative period between low-energy (LE) small incision lenticule extraction (SMILE), high-energy (HE) SMILE and femtosecond (FS)-laser in situ keratomileusis (LASIK) procedures for the correction of myopia and myopic astigmatism.
Records of patients who underwent SMILE or LASIK for myopia or myopic astigmatism performed by a single surgeon (DRH) were retrospectively reviewed. The SMILE patients were separated into two groups: HE settings (130 nJ- 150 nJ, 3.0 - 4.5 um spot spacing) and LE settings (125 nJ-130 nJ, 4.5 um spot spacing). Eyes were selected to minimize differences in mean preoperative refractive errors between groups. Age, preoperative sphere/cylinder, and preoperative corneal HOAs were recorded. UDVA was measured at postoperative day (POD) 1. Corneal HOAs and UDVA were measured at postoperative month (POM) 1. ANOVA and pairwise T-test were used to measure statistical significance between groups.
The study included 147 eyes. Amongst patients who had SMILE, the difference in mean UDVA at POD1 was highly statistically significant in favor of the LE group (20/19.86 vs 20/27.67, p<0.0001). No significant difference in mean UDVA at POD1 was noted between LE group and FS-LASIK group (20/19.86 vs 20/19.50, p= 0.50). No significant differences in POM1 mean UDVA (20/18.53 vs. 20/18.49), induced change in vertical coma (-0.082 vs -0.051), horizontal coma (-0.069 vs. -0.074), total coma (0.140 µm vs. 0.089 µm) and Total HOA (0.180 µm vs. 0.192 µm) were noted between LE SMILE and FS-LASIK. Induced change in spherical aberration was less in LE SMILE than FS- LASIK (0.132 µm vs. 0.183 µm, p=0.02).
LE SMILE settings (lower energy/spot and wider spot spacing) recently became available for use in the US. Our study demonstrates that LE settings are associated with dramatically improved POD1 UDVA compared to the HE settings. POD1 and POM1 UDVA are comparable to those of FS-LASIK. Spherical aberration induction is less with LE SMILE than FS-LASIK.
John F. Doane, MD
To report refractive outcomes of bilateral small incision lenticule extraction for spherical myopia and compound myopic astigmatism and to provide patient reported subjective outcomes / satisfaction with the procedure.
Patients with spherical myopia or compound myopic astigmatism with myopia ranging from -1 to -10 diopters and astigmatism ranging from 0 to 3 diopters with a maximum spherical equivalent of -11 diopters were treated. Refractions and uncorrected and best corrected vision for each eye separately and together were obtained preoperatively and at 2 weeks, three months and 1 year postoperatively at two separate surgical centers and clinical sites. The patients completed subjective satisfaction surveys at 2 weeks, three months and 1 year postoperatively.
On a scale of 0 to 10 at 2 weeks, 3 months and 12 months single eye subjective evaluations were 9.15( n = 228 ) , 9.55 ( n = 214 ) and 9.69 ( 104 ) whereas both eye subjective evaluations were 9.36 ( n = 114) , 9.64 ( n = 107 ) and 9.78 ( n = 52 ), respectively.
Through time the subjective evaluations of patients undergoing SMILE increased and were reported above 9 on a 10 point scale. Comparisons to LASIK would also be made.