Safety and complications of more than 1500 small-incision lenticule extraction procedures.

To evaluate the safety and complications of small-incision lenticule extraction (SMILE). Clinical control cohort study. A total of 922 healthy patients (1800 eyes) who were treated for myopia or myopic astigmatism between January 2011 and March 2013 at the Department of Ophthalmology, Aarhus, Denmark. Patients received a full preoperative examination and were treated with SMILE in both eyes and followed for 3 months (1574 eyes). Patients with complications, including loss of corrected distance visual acuity (CDVA) or dissatisfaction, were offered a late reexamination. Surgical complications and CDVA. Mean preoperative spherical equivalent refraction was -7.25±1.84 diopters (D). Average postoperative refraction was -0.28±0.52 D, and mean error of treatment was -0.15±0.50 D. By 3 months, 86% (1346 eyes) had unchanged or improved CDVA. A loss of 2 or more lines was observed in 1.5% of eyes; however, at a late follow-up visit (average, 18 months), CDVA was within 1 line of the preoperative level in all eyes. Perioperative complications included epithelial abrasions (6%), small tears at the incision (1.8%), and difficult lenticule extraction (1.9%). The cap was perforated in 4 eyes, and a major tear occurred in 1 eye; however, none of these patients had late visual symptoms. In 0.8% (14 eyes), suction was lost during surgery. Re-treatment was successful in 13 eyes, whereas 1 eye had ghost images and was re-treated with topography-guided photorefractive keratectomy (PRK). Postoperative complications included trace haze (8%), epithelial dryness on day 1 (5%), interface inflammation secondary to central abrasion (0.3%), and minor interface infiltrates (0.3%); these complications had an impact on CDVA at 3 months in only 1 case. Irregular corneal topography occurred in 1.0% of eyes, resulting in reduced 3-month CDVA (12 eyes) or ghost images (6 eyes). Topography-guided PRK was performed in 4 eyes, with improvement in 3 cases. Satisfaction was high, with only 2 patients dissatisfied at their latest visit because of blurred vision or residual astigmatism. Overall, SMILE had acceptable safety. Although 1.5% of eyes had reduced CDVA by 3 months, visual acuity was restored in the long term. Likewise, patient satisfaction was high.

Ivarsen A ，Asp S ，Hjortdal J 《-》

Past and present of corneal refractive surgery: a retrospective study of long-term results after photorefractive keratectomy and a prospective study of refractive lenticule extraction.

Surgical correction of refractive errors is becoming increasingly popular. In the 1990s, the excimer laser revolutionized the field of corneal refractive surgery with PRK and LASIK, and lately refractive lenticule extraction (ReLEx) of intracorneal tissue, using only a femtosecond laser, has become possible. Two new procedures were developed, ReLEx flex (FLEX) and ReLEx smile (SMILE). Until this thesis, only a few long-term studies of PRK with a relatively limited number of patients had been published; therefore, this thesis intended to retrospectively evaluate long-term outcomes after PRK for all degrees of myopia for a large number of patients. Furthermore, a prospective contralateral eye study comparing FLEX and SMILE, when treating high to moderate degrees of myopia, had not been performed prior to this study. This was the second aim of this thesis. In the first study, results from 160 PRK patients (289 eyes) were presented. Preoperative spherical equivalent ranged from -1.25 to -20.25 D, with 78% having low myopia (<-6 D). Average follow-up time was 16 years (range 13-19 years), making this the longest published follow-up study on PRK patients. Outcomes from eyes with low myopia were generally superior to outcomes from eyes with high myopia, at final follow-up. Seventy-two percent were within ± 1.00 D of target refraction, as compared to 47% of eyes with high myopia. However, results from a subgroup of unilateral treated PRK patients indicated that refraction at final follow-up was affected by myopic progression. Fifty percent of eyes with low myopia had uncorrected 20/20 distance visual acuity or better, as compared to 22% of eyes with high myopia. Haze did not occur if attempted corrections were <-4 D, and only eyes with high myopia lost two lines or more of CDVA (corrected distance visual acuity). Eighty-one per cent were satisfied or very satisfied with their surgery. The results support the continued use of the excimer laser for corneal surface ablation as a treatment option for correction of low degrees of myopia, and as the treatment of choice for subgroups of refractive patients (thin corneas, etc.). The results also highlight that treatment of higher degrees of myopia with standard PRK should only be done today under special circumstances, due to low refractive predictability, and high risk of corneal haze. Technological advances since then should be taken into account when comparing these results with contemporary techniques. In the second study, 35 patients were randomized to receive FLEX in one eye and SMILE in the other. Preoperative spherical equivalent refraction ranged from -6 to -10 D with low degrees of astigmatism. A total of 34 patients completed the 6 month follow-up period. Refractive and visual outcomes were very similar for the two methods, as well as tear film measurements and changes in corneal biomechanics. Ninety-seven percent were within ± 1.00 D of target refraction, no eyes lost two lines or more of CDVA, and contrast sensitivity was unaffected after both procedures. The changes in higher-order aberrations were also very similar. There were also no differences in tear film parameters 6 months after surgery, although less postoperative foreign body sensation was reported within the first week after surgery in SMILE eyes. Corneal sublayer pachymetry measurements demonstrated equally increased epithelial thickness 6 months after surgery. Contrary to expectations, it was not possible to measure the theoretical biomechanical advantages of a small corneal incision in SMILE as compared to a corneal flap in FLEX. The main differences between FLEX and SMILE were found when the corneal nerves and intraoperative complications were evaluated. Thus, corneal sensitivity was better preserved and corneal nerve morphology was less affected after SMILE, but intraoperative complications occurred more frequently, although without visual sequela. Finally, 97% were satisfied or very satisfied with both their surgeries. The results support the continued use of both FLEX and SMILE for treatment of up to high degrees of myopia. Overall, refractive and visual results for both procedures were good and similar, but from a biological point of view, the less invasive SMILE technique is more attractive, as demonstrated in this study, despite being slightly more surgically demanding than FLEX.

Vestergaard AH 《-》

Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism: Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial.

To present outcomes of the United States Food and Drug Administration premarket approval clinical trial of small-incision lenticule extraction (SMILE) for the correction of myopia and astigmatism. Prospective, multicenter clinical trial. The study included 357 eyes of 357 patients treated with SMILE (50 for myopia and 307 for myopia with astigmatism). Preoperative sphere ranged between -1.00 and -10.00 diopters (D), with manifest spherical equivalent (MSE) of up to -11.50 D and refractive cylinder of up to -3.00 D. -Participants were followed up for 12 months. Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), stability of the manifest refraction, and vector analysis of refractive cylinder are presented for the 307 eyes treated for myopia with astigmatism. Adverse events (AEs) are presented for all 357 eyes. Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events. Of the 307 astigmatic eyes enrolled in the study, 304 were treated successfully. In 3 eyes, the procedure was aborted because of intraoperative suction loss. The mean MSE reduced from -5.39±2.30 D at baseline to -0.01±0.24 D at 12 months. Of all eyes, 95.3% were within 0.50 D of emmetropia at 12 months. The percentage of eyes with UDVA of 20/20 or better was 89.0%. No loss of 2 or more lines of CDVA was observed at the 12-month visit. The refractive cylinder reduced from -1.53±0.70 D at baseline to -0.18±0.31 D at 12 months. The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism. Three intraoperative AEs associated with difficult lenticule removal and resultant cap tear occurred, and all resolved without sequelae at postoperative day 1. During the postoperative period, 8 AEs were recorded, but none of them had significant consequences. Small-incision lenticule extraction for the treatment of myopia and astigmatism was safe and effective, and the reported AEs had no significant impact on visual acuity. Slight undercorrection of refractive cylinder requires further attention.

Dishler JG ，Slade S ，Seifert S ，Schallhorn SC ... -  《-》

Visual outcomes after Epi-LASIK and PRK for low and moderate myopia.

To evaluate visual outcomes following epi-LASIK compared to photorefractive keratectomy (PRK). Of a total 294 patients aged ≥21 years, 145 (290 eyes) underwent epi-LASIK and 149 (298 eyes) underwent PRK for low to moderate myopia or myopic astigmatism. Epi-LASIK was performed with the Amadeus II epikeratome (Abbott Medical Optics) and PRK with the Amoils rotary epithelial brush (Innovative Excimer Solutions). All ablations were performed using the same excimer laser system. Outcome measures included intraoperative complications, corneal reepithelialization, postoperative pain, uncorrected distance visual acuity (UDVA), manifest refraction spherical equivalent (MRSE), corrected distance visual acuity (CDVA), corneal haze, and quality of vision. Mean preoperative MRSE was -2.97±1.19 diopters (D) for epi-LASIK versus -2.95±1.06 D for PRK. Complete reepithelialization was achieved by postoperative day 4 in 46.9% of epi-LASIK eyes versus 92.4% of PRK eyes, with superior UDVA at postoperative day 1 in the PRK group (P=.002). Using Fisher exact test, a significantly higher percentage of epi-LASIK eyes compared to PRK eyes achieved 20/15 or better at 1 month (25.8% vs 17.8%, P=.031), 3 months (62.3% vs 49.3%, P=.004), 6 months (77.1% vs 57.9%, P<.001), and 12 months (75.9% vs 61.9%, P=.002). A change in MRSE >0.50 D occurred in 8.4% of epi-LASIK eyes within the 3- and 12-month interval versus 17.7% of PRK eyes (P=.04). No differences were noted between the two procedures in CDVA or clinically significant haze. Epi-LASIK showed superior refractive efficacy and stability but required more time for wound healing, resulting in inferior early visual outcomes and a tendency to overcorrect higher refractive errors compared to PRK. Both treatments were safe and comparable in terms of pain and haze formation.

Sia RK ，Coe CD ，Edwards JD ，Ryan DS ，Bower KS ... -  《JOURNAL OF REFRACTIVE SURGERY》

Short and long term outcomes after small-incision lenticule extraction: A tertiary referral centre experience.

The objective of this study is to evaluate the preoperative and short- and long-term postoperative results in terms of visual acuity, refractive error, and corneal wavefront aberrations in patients with myopia and myopic astigmatism undergoing small incision lenticule extraction (SMILE). Seventy-nine eyes of 52 myopes with or without astigmatism (41 right and 38 left) were enrolled in this retrospective study. The measurements included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent (SE) and wavefront aberrations. All the measurements before and after SMILE surgery were systematically recorded. Mean preoperative UDVA was 1.19±0.24 logMAR and improved to 0.06±0.17 logMAR at the 3-year postoperative follow-up. At the conclusion of the 3-year follow-up, UDVA was better than or equal to 20/20 and 20/25 in 73% and 84% of eyes, respectively. At 1 month postoperatively, CDVA was 0.05±0.23 logMAR and significantly lower than the preoperative CDVA, 0.02±0.04 log MAR (P>0.05). However, at 1 year and 3 years after surgery, CDVA showed a significant increase compared to preoperative CDVA. At the conclusion of the 3-year follow-up, SE was -0.47 D, and 69.6% and 83.5% of the eyes were within±0.50 D and±1.00 D, respectively, of the intended correction. HOA's, coma, and spherical aberration increased significantly. No significant change in trefoil was detected. This study showed that SMILE produces a stable, safe outcome for surgical treatment of myopia and myopic astigmatism.

Yesilkaya C ，Arıcı M ，Yıldırım Y ，Agca A ，Demircan A ，Taskapılı M ... -  《-》