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Purpose. To evaluate clinical outcome during 24 months follow-up between small incision lenticule extraction combined with cross-linking (SMILE Xtra) and small incision lenticule extraction (SMILE) only. Setting. Ophthalmology Division of San Rossore Medical Center, Pisa, Italy. Design. Retrospective comparative case series. Methods. The study comprised 70 eyes (35 patients); 40 eyes were corrected using SMILE and 30 eyes were corrected using SMILE Xtra using a low energy protocol. The outcomes were compared at 1, 6, 12, and 24 months postoperatively. Results. The mean spherical equivalent (SEQ) reduced from −7.18 ± 1.21 D to −0.01 ± 0.09 D in the SMILE group and from −6.20 ± 2.99 D to −0.04 ± 0.1 D postoperatively in SMILE Xtra (p < 0.05). At 24 months the mean SEQs were −0.01 ± 0.24 D for SMILE and −0.15 ± 0.33 D for SMILE Xtra (p > 0.05). At 1, 6, 12, and 24 months, there were no statistically significant differences between the SMILE and SMILE Xtra groups in logarithm of the minimum angle of resolution (logMAR) uncorrected distance visual acuity (UDVA), safety, and efficacy index (p > 0.05). The mean average keratometry (K-avg) at 1, 6, 12, and 24 months after surgery did not shown any statistically significant difference between SMILE and SMILE Xtra group (p > 0.05). The mean maximum keratometry (K-max) readings at 1, 6, 12, and 24 months were not statistically significant between SMILE and SMILE Xtra group (p > 0.05). The preoperative mean thinnest point pachymetry (TTP) was 543.90 ± 22.85 μm in the SMILE group and 523.40 ± 37.01 μm in the SMILE Xtra group (p < 0.05). At 1, 6, 12, and 24 months the mean TTP was not statistically significant between the SMILE and SMILE Xtra groups (p > 0.05). At 24 months, the TTP was 408.29 ± 38.75 μm for the SMILE group and 402.22 ± 37 μm for the SMILE Xtra group (p > 0.05). In the preoperative period, the mean maximum posterior elevation (MPE) was 8.63 ± 4.35 μm for SMILE and 8.13 ± 2.54 μm for SMILE Xtra (p > 0.05). After the surgical procedure, both groups showed a statistically significant increase of the MPE (p < 0.05). At 24 months, the MPE was 11.00 ± 4.72 μm for SMILE Xtra and 10.14 ± 3.85 μm for the SMILE group (p > 0.05). In the preoperative period, the means of the root mean square (RMS) of high-order aberration (HOA) were 0.08 ± 0.03 μm for the SMILE group and 0.08 ± 0.03 μm for the SMILE Xtra group (p > 0.05). At 24 months, the RMS of HOA was 0.13 ± 0.07 μm for the SMILE group and 0.14 ± 0.07 μm for the SMILE Xtra group (p > 0.05). In the preoperative period, the root mean square of coma aberration (RMS-Coma) aberration was 0.06 ± 0.09 μm for the SMILE group and 0.04 ± 0.03 μm for the SMILE Xtra group (p > 0.05). At 24 months, the coma aberration of SMILE group was 0.12 ± 0.21 μm and 0.16 ± 0.25 μm for SMILE Xtra group (p > 0.05). Conclusions. SMILE Xtra procedure is a safe and simple procedure that can be offered to patients with high corneal ectasia risk because there were no differences in the indices of ectasia compared to the group treated only with SMILE which has a low corneal ectatic risk. [ABSTRACT FROM AUTHOR]

Purpose. To study the corneal morphology and biomechanics in cases of small incision lenticule extraction with prophylactic accelerated collagen cross-linking (SMILE Xtra). Methods. This study was a retrospective study. 28 eyes of 14 patients with moderate-high risk of postoperative ectasia according to the Randleman scoring system underwent SMILE Xtra procedure. Outcome data were recorded including uncorrected distance visual acuity (UDVA), manifest refraction spherical equivalent (MRSE), surface regularity index (SRI), surface asymmetry index (SAI), simulated keratometry (SimK), posterior axial curvature (PAC), anterior and posterior corneal elevations (ACE and PCE), central corneal thickness (CCT), corneal resistance factor (CRF), corneal hysteresis (CH), and cornea-compensated intraocular pressure (IOPcc). The follow-up period was 12 months. Results. There were 28, 26, 22, 12, and 10 eyes enrolled at postoperative 1st day and 1st, 3rd, 6th, and 12th months, respectively. The UDVA improved from 1.27 ± 0.18 logMAR preoperatively to -0.06 ± 0.04 logMAR postoperatively (P < 0.05). The MRSE improved from -5.05 ± 1.15 D preoperatively to -0.14 ± 0.30 D postoperatively (P < 0.05). SAI, SimK, PAC, PCE, and CCT all changed significantly at 1st month postoperatively (P < 0.05) and stabilized during the remainder of the follow-up (P > 0.05). There was no significant change in SRI or ACE before and after surgery (P > 0.05). CRF, CH, and IOPcc all decreased significantly at 1st month postoperatively (P < 0.05) and remained stable afterwards (P > 0.05). Conclusions. The changes in the corneal morphology and biomechanics remained stable after SMILE Xtra, and there was no sign of postoperative ectasia or refractive regression. Combined with the improvement of visual and refractive results, SMILE Xtra may be a promising method for corneal refractive surgeries in patients at risk. [ABSTRACT FROM AUTHOR]

Purpose. To compare the long-term safety, efficacy, predictability, and refractive stability following SMILE versus SMILE combined with accelerated cross-linking (SMILE XTRA), and to specifically study the regression patterns following the two procedures. Methods. This retrospective study included 54 eyes of SMILE and 54 eyes of SMILE XTRA treated for normal and borderline cases of myopia/myopic astigmatism, respectively, based on certain predefined topographic features and risk factors. Patients in both the groups were matched for age and refractive error. The mean postoperative follow-up for the SMILE group was 22.18 ± 10.41 months and the SMILE XTRA group was 21.81 ± 10.19 months. Results. At the end of follow-up, the mean sphere, cylinder, and SE reduced to −0.03, −0.09, and −0.08 D in the SMILE group and −0.06, −0.15, and −0.13 D in the SMILE XTRA group. 96% and 93% eyes remained within ±0.50 D in SMILE and SMILE XTRA groups, respectively, and 94% eyes maintained an UDVA of 20/20 or better in the SMILE as well as SMILE XTRA groups. Safety and efficacy indices for the SMILE group were 1.03 and 1.00. For the SMILE XTRA group, the safety and efficacy indices were 1.00 and 0.99. No eye in either group had postoperative ectasia or enhancement performed for significant residual refractive error. Conclusion. Both the SMILE and SMILE XTRA groups exhibited comparable visual outcomes, safety, and efficacy. Contrary to the belief, combination of prophylactic CXL with SMILE did not result in a hyperopic shift in the long term. No eye in either group encountered postoperative ectasia; however, further follow-up is suggested to establish the long-term effects on refractive and corneal stability following SMILE XTRA, as all the eyes treated in this group were borderline. [ABSTRACT FROM AUTHOR]

Purpose. To assess the efficacy, safety, and predictability of the Visian Implantable Collamer Lens (ICL) model having a central port in patients over 40 years of age. Methods. This study included 33 eyes from 21 patients who underwent V4c ICL implantation for the correction of myopia and myopic astigmatism. We assessed uncorrected (UDVA) and corrected (CDVA) distance visual acuity, refraction, intraocular pressure (IOP), endothelial cell density (ECD), vault, and adverse events occurring over a 1-year period. Results. Mean age of the patients at the time of implantation was 43.52 ± 4.49 years (range: 40 to 56 years). Efficacy and safety indexes were 1 and 1.09, respectively. Surgical outcomes for CDVA were as follows: no eye lost any lines, 19 eyes (57.58%) showed no CDVA changes, 7 eyes (21.21%) gained 1 line, 4 eyes (12.12%) gained 2 lines, and 3 eyes (9.09%) gained ≥3 lines. Mean postoperative spherical equivalent (SE) was −0.09 ± 0.47 D. A total of 29 eyes (87.8%) were within ±0.50 D and 31 eyes (93.9%) were within ±1.00 D of the desired SE. At 1-year, mean IOP was 15.27 ± 3.03 mmHg (range: 9 to 20 mmHg, p = 0.12 pre vs. post) and mean ECD was 2516 ± 234 cells/mm2 (p = 0.29 pre vs. post). Mean postoperative vault was 320 ± 136 μm, with 201–300 μm being the most prevalent vault range for 9 eyes (31.03%). None of the eyes showed a vault >701 μm. There were neither intraoperative nor postoperative complications; in fact, all ICL implantation procedures were uneventful. Conclusions. Our study's findings support the use of this lens in patients over 40 years of age. A long follow-up period is advisable to monitor ICL position relative to the crystalline lens. [ABSTRACT FROM AUTHOR]

Purpose. To assess the safety and stability in cases of small incision lenticule extraction with collagen cross-linking (SMILE Xtra). Methods. This study was a retrospective interventional comparative study that included 60 eyes of 30 patients divided equally into two groups: SMILE Xtra and SMILE alone. The inclusion criteria were patients >18 years of age, myopic error >6 D, thinner cornea <520 microns, and abnormal corneal topography. Outcome data were recorded including uncorrected distance visual acuity and corrected distance visual acuity (UDVA and CDVA), manifest refraction spherical equivalent (MRSE), central corneal thickness, average keratometry, endothelial cell density, corneal resistance factor (CRF), and corneal densitometry. The follow-up period was 24 months. Results. There was a significant difference between the 2 groups regarding UDVA, CDVA, and MRSE at 1 month. In the SMILE Xtra group, 90% of eyes had postoperative UDVA of 20/20 and 97% had UDVA of 20/30 at 24 months. At 24 months, 26 eyes (87%) vs. 25 eyes (84%) were within ±0.50 D of attempted correction in SMILE Xtra and SMILE groups, respectively. Regarding stability, both groups showed improvement of MRSE at 1st month postoperatively and remained stable along the 24 months of follow-up. CRF and corneal densitometry were higher in the SMILE Xtra group along the whole follow-up period (p=0.001). Conclusion. Combining corneal cross-linking with SMILE procedure (SMILE Xtra) is a promising tool to prevent ectasia in high-risk patients. It is a safe and simple procedure that can be offered to patients undergoing SMILE with risk for ectasia. Trial registration no: PACTR201810577524718. [ABSTRACT FROM AUTHOR]