The clinical use of femtosecond lasers has led to significant progress in a number of surgical procedures in ophthalmology. In the field of corneal refractive surgery, a one-step intrastromal laser procedure without a flap has been established for the first time. This review follows the development of this surgical procedure.

PURPOSE To investigate the safety and effectiveness of small incision lenticule extraction (SMILE) in patients who have hyperopia with or without astigmatism. METHODS This was a prospective multicenter trial including 374 eyes of 199 patients treated by SMILE for hyperopia using the VisuMax femtosecond laser (Carl Zeiss Meditec AG). Inclusion criteria were sphere up to +6.00 diopters (D), cylinder up to 5.00 D, and maximum hyperopic meridian up to +7.00 D, with preoperative corrected distance visual acuity (CDVA) of 20/25 or better. The optical zone was 6.3 mm with a transition zone of 2 mm. The minimum lenticule thickness was set at 25 µm in the center and at 10 µm at the edge. Patients were examined at 1 day, 1 week, and 1, 3, 6, 9, and 12 months after surgery. Standard refractive surgery outcomes analysis was performed. RESULTS The preoperative spherical equivalent was +3.20 ± 1.48 D (range: +0.25 to +6.50 D). At the 12-month follow-up visit, 81% of eyes treated were within ±0.50 D and 93% of eyes were within ±1.00 D of intended correction. A total of 1.2% of eyes lost two or more lines of CDVA at the 12-month follow-up visit, and 83% were at least 20/20, corresponding to a safety index of 1.005 at 12 months. Of the 219 eyes with plano target, 68.8% had an uncorrected distance visual acuity of 20/20 or better and 88% were at least 20/25 uncorrected at 12 months. There were no statistically significant changes in contrast sensitivity. CONCLUSIONS SMILE was found to be an effective treatment method for the correction of compound hyperopic astigmatism, demonstrating a high level of efficacy, predictability, safety, and stability. [J Refract Surg. 2022;38(12):760-769.].

Background: To investigate whether vaccination against SARS-CoV-2 is associated with the onset of retinal vascular occlusive disease (RVOD). Methods: In this multicentre study, data from patients with central and branch retinal vein occlusion (CRVO and BRVO), central and branch retinal artery occlusion (CRAO and BRAO), and anterior ischaemic optic neuropathy (AION) were retrospectively collected during a 2-month index period (1 June–31 July 2021) according to a defined protocol. The relation to any previous vaccination was documented for the consecutive case series. Numbers of RVOD and COVID-19 vaccination were investigated in a case-by-case analysis. A case–control study using age- and sex-matched controls from the general population (study participants from the Gutenberg Health Study) and an adjusted conditional logistic regression analysis was conducted. Results: Four hundred and twenty-one subjects presenting during the index period (61 days) were enrolled: one hundred and twenty-one patients with CRVO, seventy-five with BRVO, fifty-six with CRAO, sixty-five with BRAO, and one hundred and four with AION. Three hundred and thirty-two (78.9%) patients had been vaccinated before the onset of RVOD. The vaccines given were BNT162b2/BioNTech/Pfizer (n = 221), followed by ChadOx1/AstraZeneca (n = 57), mRNA-1273/Moderna (n = 21), and Ad26.COV2.S/Johnson & Johnson (n = 11; unknown n = 22). Our case–control analysis integrating population-based data from the GHS yielded no evidence of an increased risk after COVID-19 vaccination (OR = 0.93; 95% CI: 0.60–1.45, p = 0.75) in connection with a vaccination within a 4-week window. Conclusions: To date, there has been no evidence of any association between SARS-CoV-2 vaccination and a higher RVOD risk.

PURPOSE:To evaluate the 10-year results of refractive lenticule extraction using the small incision lenticule extraction (SMILE) technique for treatment of myopia and myopic astigmatism.METHODS:In 2008-2009, the first 91 eyes were treated using a novel surgical technique (SMILE), in which a refractive lenticule of intrastromal corneal tissue is removed through a small incision, completely eliminating flap cutting. A total of 56 of 91 eyes of the original treatment group volunteered for reexamination 10 years after surgery, including uncorrected and corrected distance visual acuity, objective and manifest refraction, and evaluation of the interface and corneal surface by slit-lamp examination. Late side effects such as corneal scarring, corneal ectasia, persistent dry eye symptoms, or cataract were documented.RESULTS:At 10 years postoperatively, there was no significant change from the 6-month results. Spherical equivalent was -0.35 ± 0.66 diopters and therefore close to target refraction. Sixteen of the 56 eyes (29%) had gained one to two Snellen lines. There was no loss of two or more lines in the long term. Regression was -0.35 ± 0.66 diopters over the 10-year period.CONCLUSIONS:This 10-year long-term study demonstrates SMILE to be an effective, stable, and safe procedure for the treatment of myopia and myopic astigmatism. [J Refract Surg. 2019;35(10):618-623.].

PURPOSE: To evaluate the 10-year results of femtosecond lenticule extraction (FLEx) for treatment of myopia and myopic astigmatism. METHODS: This long-term follow-up of a prospective clinical trial was conducted at HELIOS Klinikum Erfurt and Phillips University of Marburg, Germany. In 2006, 108 eyes underwent the FLEx procedure. All patients were invited for reexamination 10 years after FLEx treatment for myopia and astigmatism. Visual acuity, objective and manifest refraction, intraocular pressure, and slit-lamp examination and side effects were documented. Main outcome measures were uncorrected (UDVA) and corrected (CDVA) distance visual acuity, objective and manifest refraction, and slit-lamp examination and side effects. RESULTS: A total of 77 eyes of 40 patients of the original treatment group volunteered for a reexamination 10 years after surgery. The mean age of the patients was 45.9 years; 26 were women and 14 were men. UDVA was 0.09 +/- 0.19 logMAR and CDVA was stable at -0.1 +/- 0.09 logMAR. More than half of the eyes gained one or two Snellen lines, and none of the eyes lost two or more lines. Over the 10-year period, regression was 0.18 D. CONCLUSIONS: FLEx has stable results 10 years after treatment for myopia and astigmatism.

PURPOSE:To investigate new lenticule profiles for the treatment of hyperopia by femtosecond lenticule extraction (FLEx) for spherocylindrical hyperopia using a modified laser scan sequence.METHODS:In this prospective 9-month study, 39 eyes of 22 patients with the mean age of 49 years (range: 27 to 56 years) underwent hyperopic FLEx. The mean optical zone was 6 mm (range: 5.75 to 6.75 mm) with keratometry readings and magnitude of correction adjusted mean transition zone of 2.1 mm (range: 1.80 to 2.89 mm). The lenticule thickness was set at 25 μm in the center and 10 μm at the edge.RESULTS:Preoperative spherical equivalent manifest refraction was +1.96 ± 1.04 diopters (D) (range: +0.63 to +4.50 D). Because of the presbyopic age, the treatment was aimed at low myopia in 75% of the eyes treated. At the final 9-month follow-up visit, the mean spherical equivalent was -0.40 ± 0.61 D (range: -1.50 to +0.75 D), with 70% of eyes treated within ±0.50 D and 89% of eyes within ±1.00 D of intended correction. The regression was +0.29 D between 1 week and 6 months but 0.03 D between 6 and 9 months. A total of 10% of eyes lost one line of corrected distance visual acuity, respectively. There were no losses of two or more lines of visual acuity or any serious intraoperative or postoperative complications.CONCLUSIONS:Treatment of spherocylindrical hyperopia by FLEx led to refractive results similar to published outcomes on hyperopic femtosecond laser-assisted LASIK. [J Refract Surg. 2018;34(1):6-10.].

Refractive lenticule extraction (ReLEx/SMILE) is a refractive surgical method developed by the authors in stages primarily for correction of myopia and myopic astigmatism, in which a femtosecond laser is exclusively used. In the (ReLEx/SMILE) method a refractive lenticule is generated by the femtosecond laser, which is subsequently extracted through a small incision. Opening of the corneal surface with a flap and use of an excimer laser is no longer necessary. In 2013 the method was newly assessed and classified by the Joint Commisssion for Refractive Surgery (KRC) of the Professional Association of Ophthalmologists (BVA) and the German Ophthalmological Society (DOG). This article presents the individual stages of the technique in a video and possible errors and their avoidance are explained.

BACKGROUND:To evaluate the 5-year results of Refractive Lenticule Extraction (ReLEx) as Small Incision Lenticule Extraction (SMILE) technique for treatment of myopia and myopic astigmatism. METHODS:In 2008/2009, the worldwide first 91 eyes were treated using a novel surgical technique (SMILE), where a refractive lenticule of intrastromal corneal tissue is removed though a small incision completely eliminating flap-cutting. 56 out of 91 eyes of the original treatment group volunteered for re-examination 5 years after surgery. Uncorrected distance visual acuity and corrected distance visual acuity after 5 years, objective and manifest refractions as well as evaluation of the interface and corneal surface by slit-lamp examination were documented. Late side effects like corneal scars, corneal ectasia, persistent dry eye symptoms or cataract were documented. RESULTS:5 years postoperatively, no significant change to the 6-month data was found. Spherical equivalent was -0.375 D and therefore close to target refraction (emmetropia). 32 of the 56 eyes had gained 1-2 Snellen lines. There was no loss of 2 or more lines over the 5-year period. Regression in the long term was 0.48 D. CONCLUSIONS:This first long-term study demonstrates SMILE to be an effective, stable and safe procedure for treatment of myopia and myopic astigmatism. CLINICAL TRIAL NUMBER:DE/CA93/KP/07/001. Post-results.

The aim of this study is to establish and to prove a new lenticule shape for the treatment of hyperopia using a 500 kHz femtosecond laser and the femtosecond lenticule extraction (ReLEx® FLEx) technique. Improved lenticule shapes with a large transition zone of at least 2 mm adjusted to the 5.75 mm optical zone were designed. A prospective pilot study on nine eyes of five patients who underwent an uncomplicated FLEx using VisuMax® femtosecond laser (Carl Zeiss Meditec AG) for spherical hyperopia was performed. Patients’ mean age was 55.5 years, and the preoperative manifest spherical equivalent (SE) was +1.82 D (range +1.25 to +3.00 D). Because of the presbyopic age and in order to compensate for a possible regression, the treatment was aimed at low myopia (mean target SE was −0.88 D with a mean treatment refraction of +2.69 D). At the last follow-up, after 9 months, 33 % were within ±0.50 D and 78 % within ±1.00 D of intended correction. Thirty-three percent lost one line, and 11 % gained one line corrected distance visual acuity (CDVA). On average, the centre of the optical zone was 0.34 ± 0.17 mm from the corneal vertex. No adverse effects were observed. This pilot study confirms that the improved lenticule’s design with a large optical and transition zone can achieve good centration and acceptable results for spherical hyperopia using FLEx. The next steps are to extend the study to spherocylindrical hyperopic treatments and to increase the number of eyes for better assessment of refractive outcome.

PURPOSE: To estimate the repeatability of biometric parameters obtained with a new swept-source biometer and to compare the agreement with that of partial coherence interferometry (PCI) and optical low-coherence reflectometry (OLCR).SETTING: Department of Ophthalmology, Helios Hospital Erfurt, Erfurt, Julius-Maximilians University, Wurzburg, and Philipps University, Marburg, Germany.DESIGN: Prospective comparative multicenter clinical study.METHODS: Biometry was taken with the use of 3 different biometers: the IOLMaster 700 swept source biometer, the PCI-based IOLMaster 500, and the OCLR-based Lenstar LS 900. Axial length (AL), anterior chamber depth (ACD), and spherical equivalent (SE) were compared between swept source and PCI biometry and central corneal thickness (CCT) and lens thickness (LT) between swept-source and OLCR biometry. The repeatability of swept-source biometry was evaluated on the basis of 3 measurements captured for each patient.RESULTS: One hundred twenty cataract eyes were included in the study. The mean difference between swept-source and PCI biometry for AL, ACD, and SE measurements was 4 mu m +/- 25 (SD), 17 +/- 122 mu m, and -0.001 +/- 0.19 diopter (D), respectively. The mean difference between swept-source and OLCR biometry for LT and CCT measurements was 21 +/- 122 mu m and 0.15 +/- 4.51 mu m, respectively. Differences between swept-source biometry and the other devices distributed around zero without statistical significance. The standard deviation of repeatability for AL, ACD, LT, CCT, and SE was 8.8 mu m, 9.8 mu m, 2.3 mu m, 19.5 mu m, and 0.1 D, respectively.CONCLUSIONS: Swept-source biometry showed high repeatability performance for all biometric parameters. The agreement of AL, ACD, and SE between swept-source and PCI biometry as well as that of LT and CCT between swept-source and OLCR biometry was excellent. It remains to be validated whether high repeatability shown by swept-source biometry will result in better postoperative refractive outcomes.

PURPOSE:To assess the scan quality of foveal pit morphology (FPM) and to quantify central retinal thickness (CRT) during routine optical biometry measurements with a full-eye-length swept-source optical coherence tomography (SS-OCT) scan biometer prototype (IOLMaster700) and to compare these results with standard examinations using spectral-domain optical coherence tomography (SD-OCT) technique (Cirrus4000 SD-OCT).METHODS:As part of a SS-OCT scan protocol to measure biometric parameters for intraocular lens power calculation, central horizontal 1 mm retinal B scans were taken from phakic (group I) and pseudophakic (group II) nonvitrectomized eyes. To evaluate FPM, macular scans of either examination technique were subjectively analyzed and compared. Repeated CRT measurements were performed to analyze repeatability and consistency of IOLMaster700 recordings. These results were compared with CRT evaluations using SD-OCT.RESULTS:Overall, 146 eyes of 146 patients were included in this series. The subjective assessments of FPM are illustrated. Repeated CRT measurements (repeatability) with the IOLMaster700 disclosed an overall intraclass correlation of 0.57 (group I: 0.48; group II: 0.89). Overall coefficient of variation (accuracy) was calculated to be 12.43% (group I: 14.21%; group II: 5.66%). The comparison of CRT measurements between both devices showed significant differences in group I (p = 0.006).CONCLUSIONS:Compared with SD-OCT, resolution of the 1 mm retinal B scan of SS-OCT scan biometry was lower. However, advanced pathologic characteristics were clearly discernible. Repeatability and accuracy of CRT measurements were acceptable though lower than with the standard SD-OCT technique. The CRT differed significantly in eyes of particular interest (group I) between both devices. The new scan could provide useful information for subsequent patient examination and further treatment planning for cataract surgery.