PURPOSE: To compare the safety, efficacy, and patient-reported quality of vision of small incision lenticule extraction (SMILE) and implantable Collamer lens (ICL) implantation for the treatment of high myopia. METHODS: A database of 1,634 SMILE (Carl Zeiss Meditec AG, Jena, Germany) and 225 ICL implantation (STAAR Surgical, Monrovia, CA) procedures was screened for patients with a binocular preoperative manifest refraction spherical equivalent between −6.00 and −10.00 diopters (D) and plano target refraction. One-to-one matching was performed by preoperative manifest refraction spherical equivalent, age, and pupil size. All identified patients were then prospectively examined at their next regular postoperative follow-up visit and presented with the standardized and clinically validated Quality of Vision questionnaire to gauge patient-reported postoperative visual quality. RESULTS: A total of 80 eyes (40 patients) were eligible for 1:1 matching. Mean postoperative follow-up was 27.8 ± 14.3 months in the SMILE group and 26.6 ± 17.7 months in the ICL group ( P = .44). Regarding the percentage of eyes within ±0.50 D of plano target, refractive predictability was better in eyes treated with ICL implantation (90%) than SMILE (72.5%) ( P = .045). Mean UDVA was comparable (ICL: −0.09 ± 0.10 logMAR; SMILE: −0.06 ± 0.09 logMAR; P < .09), but the efficacy (1.28 vs 1.05; P < .001) and safety (1.31 ± 0.22 vs 1.10 ± 0.25; P < .001) indices were higher after ICL implantation. ICL implantation induced significantly fewer higher order aberrations (total higher order aberrations: SMILE 0.724 ± 0.174 µm vs ICL 0.436 ± 0.114 µm; P < .01). Regarding subjective quality of vision, patients who had ICL implantation were significantly less bothered by visual disturbances, which were mainly halos after ICL and starbursts and fluctuations of vision after SMILE ( P < .05). CONCLUSIONS: In this refraction-matched comparative study, ICL implantation for high myopia yielded better refractive accuracy, better uncorrected distance visual acuity, fewer higher order aberrations, and better subjective quality of vision than SMILE. [ J Refract Surg . 2020;36(3):150–159.]

Purpose: To analyse in depth the associations between objectively measured corneal higher‐order aberrations (HOAs) and subjectively perceived visual quality after small incision lenticule extraction (SMILE) as quantified with the standardized and clinically validated quality of vision (QOV) questionnaire.Methods: This cross‐sectional study included patients after bilateral simultaneous SMILE for the treatment of myopia and/or myopic astigmatism with plano target refraction. Scheimpflug imaging (Pentacam HR; Oculus Optikgeräte GmbH, Wetzlar, Germany) was used to objectively quantify corneal HOAs. The standardized and validated QOV questionnaire was employed to gauge patients’ subjectively perceived visual quality regarding frequency, severity and bothering effect of visual disturbances.Results: A total of 394 eyes of 197 patients with a mean age of 32.4 ± 7.7 years and a mean postoperative follow‐up of 24.3 ± 14.1 months were included. SMILE induced a statistically significant (p < 0.001) increase in spherical aberration (0.074 ± 0.131 µm), coma (0.142 ± 0.179 µm), trefoil (0.018 ± 0.067 µm) as well as in total HOAs (0.191 ± 0.176 µm). Surgically induced and postoperative levels of HOA showed no correlation with the three QOV scores representative of overall visual symptom frequency, severity and bothering effect (all R² values ≤ 0.016). In addition, the associations between specific visual symptoms (e.g. starburst) and singular HOA terms (e.g. haloes) were very weak (all Rho values ≤ 0.164).Conclusions: Small incision lenticule extraction induced significant amounts of corneal HOAs that, however, showed no clear relationships to patient‐reported QOV or specific long‐term visual symptoms.

Purpose: To evaluate the outcomes of myopic small incision lenticule extraction (SMILE) monovision in presbyopic patients. Methods: This study included 49 presbyopic patients older than 45 years seeking surgical correction of myopia or myopic astigmatism who underwent bilateral SMILE with planned monovision in the SMILE Eyes Clinic Linz, Austria. Target refraction was plano for dominant (distance) eyes and ranged between -1.25 and -0.50 D for nondominant (near) eyes. Best-corrected distance visual acuity, uncorrected distance visual acuity (UDVA), uncorrected near visual acuity, as well as spectacle dependence were assessed after a mean postoperative period of 7.2 ± 4.8 months. Results: Mean age was 49 ± 3 years and female to male ratio was 30:19. Distance eyes achieved a spherical equivalent correction of ±0.50 D from target refraction in 80% of patients and 96% were within ±1.0 D. Binocular UDVA of 20/20 or better was achieved by 90% of patients and all patients achieved 20/25 or better. The proportion of patients with a binocular UDVA of 20/20 or better who could read J2 or better amounted to 84%. Complete spectacle independence was achieved by 84% of patients and independence from reading glasses was achieved in 92% of cases. No patient requested refractive enhancement or monovision reversal. Conclusions: This first evaluation of SMILE monovision endorses the approach as a safe and effective option for the correction of presbyopia in myopic patients seeking refractive surgery.

To characterize patient-reported long-term quality of vision (QoV) after small-incision lenticule extraction (SMILE), and to identify potential clinical parameters that might predispose to experiencing deteriorated visual quality. University Eye Hospital, Ludwig-Maximilians-University, Munich, Germany. Prospective cross-sectional study. For the assessment and scoring of visual symptoms, the Quality of Vision questionnaire was employed, which constitutes a clinically validated, linear-scaled 30-item instrument providing a QoV score on three scales (symptom frequency, severity, and bothersome). Subgroup analyses were performed for patient subgroups stratified by baseline characteristics (eg, age) and treatment parameters (eg, surgical refractive correction) as well as refractive outcomes (eg, residual refraction) and visual outcomes (eg, uncorrected distance visual acuity [UDVA]). The study comprised 394 eyes of 197 patients (117 women [59.4%], 80 men [40.6%]) were included with a mean postoperative follow-up of 24.4 months ± 14.1 (SD). The QoV scores for symptom frequency, severity, and bothersome were 34.63 ± 13.69, 29.60 ± 12.38, and 24.56 ± 16.00, respectively. Patients with a preoperative binocular corrected distance visual acuity (CDVA) of 20/12.5 or better, patients who lost 1 or more lines of UDVA as compared with preoperative CDVA, patients older than the age of 40, and patients with inadvertent anisometropia more than 0.375 diopters reported worse QoV scores. The relationship between objective clinical parameters and patient-reported subjective QoV after SMILE seems complex. Defined prognostic factors that convey a higher risk for experiencing visual disturbances were identifiable and should be discussed with patients seeking SMILE treatment during preoperative counseling.

Purpose: There is an ongoing controversial debate about the effectiveness of laser treatments in chronic central serous chorioretinopathy (cCSC). We performed a prospective non-randomized interventional study to learn about the effects of a subthreshold laser treatment (Topcon Endpoint Management™, Topcon Healthcare Inc., Tokyo, Japan) in patients with cCSC. Methods: Patients with cCSC and a minimum symptom duration of 4 months were included and treated with a standardized laser pattern covering the macular area. Retreatment was performed every 3 months if persistent subretinal fluid was observed. The primary endpoint was resolution of subretinal fluid at 6 months. Further outcome parameters included best corrected visual acuity, microperimetry, central macular and subfoveal choroidal thickness. Results: A total of 42 eyes of 39 patients were included. Mean patient age was 48 ± 10.6 years (range 25–67). Mean symptomatic time before inclusion into the study was 134 ± 133.4 weeks (16–518). Before inclusion, 78.6% of the patients had failed to resolve subretinal fluid under mineralocorticoid receptor antagonists and 14.3% had a recurrence after half-dose photodynamic therapy. Complete resolution of subretinal fluid was observed in 42.9% at 6 months and in 53.8% at 12 months after baseline. Central retinal thickness decreased from 398 ± 135 µm to 291 ± 68 µm (p < 0.001), subfoveal choroidal thickness changed slightly (430 ± 116 µm to 419 ± 113 µm, p = 0.026), microperimetry-derived macular function improved by 19.1 ± 4.7 dB to 21.3 ± 4.8 dB (p = 0.008) and mean BCVA improved by 4.9 ± 8.6 ETDRS letters (p < 0.001). Conclusion: The results show that the investigated laser treatment is effective in reducing subretinal fluid and leads to an improvement of functional parameters.

With more than 1.5 million Small Incision Lenticule Extraction (SMILE) procedures having already been performed worldwide in an ageing population, intraocular lens (IOL) power calculation in post-SMILE eyes will inevitably become a common challenge for ophthalmologists. Since no refractive outcomes of cataract surgery following SMILE have been published, there is a lack of empirical data for optimizing IOL power calculation. Using the ray tracing as the standard of reference – a purely physical method that obviates the need for any empirical optimization - we analyzed the agreement of various IOL power calculation formulas derived from the American Society of Cataract and Refractive Surgeons (ASCRS) post-keratorefractive surgery online calculator. In our study of 88 post-SMILE eyes, the Masket formula showed the smallest mean prediction error [−0.36 ± 0.32 diopters (D)] and median absolute error (0.33D) and yielded the largest percentage of eyes within ±0.50D (70%) in reference to ray tracing. Non-inferior refractive prediction errors and ±0.50D accuracies were achieved by the Barrett True K, Barrett True K No History and the Potvin-Hill formula. Use of these formulas in conjunction with ray tracing is recommended until sufficient data for empirical optimization of IOL power calculation after SMILE is available.