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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.]

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. [ J Refract Surg . 2019;35(11):707–711.]

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.]

Journal of Clinical Medicine (17), 5101 (2022). doi:10.3390/jcm11175101, Published by MDPI, Basel

Durch die Einfuhrung der Femtosekundenlaser in die klinische Augenheilkunde wurde in der refraktiven Chirurgie ein deutlicher Qualitatsfortschritt erzielt. Erstmals ist es mit dem SMILE-Verfahren (SMILE: Small-Incision-Lentikel-Extraktion) moglich, die Korrektur im Stroma der Hornhaut nur mit einem Laser ohne Anheben eines Flaps durchzufuhren. Der Ubersichtsartikel zeigt die schrittweise Entwicklung bis zu diesem mittlerweile international etablierten Verfahren.

In the last 20 years, the role of ultrashort pulsed lasers in ophthalmology has become increasingly important. However, it is still impossible to guide ultra-short laser pulses with standard glass fibres. The highly energetic femtosecond pulses would destroy the fibre material, and non-linear dispersion effects would significantly change beam parameters. In contrast, photonic crystal fibres mainly guide the laser pulses in air, so that absorption and dispersive pulse broadening have essentially no effect. This article compares classical beam guidance with mirrors, lenses and prisms with photonic crystal fibres and describes the underlying concepts and the current state of technology. A classical mirror arm possesses more variable optical properties, while the HCF (Hollow-Core Photonic Crystal Fibre) must be matched in terms of the laser energy and the laser spectrum. In contrast, the HCF has more advantages in respect of handling, system integration and costs. For applications based on photodisruptive laser-tissue interaction, the relatively low damage threshold of photonic crystal fibres compared to classic beam guiding systems is unacceptable. If, however, pulsed laser radiation has a sufficiently low peak intensity, e.g. as used for plasma-induced ablation, photonic crystal fibres can definitely be considered as an alternative solution to classic beam guidance.

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.

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.

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.

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 μ m in the center and 10 μ m 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.]

Corneal resectional refractive procedures for the correction of myopia were pioneered by Barraquer and Ruiz in the 60s and 70s [1]. They removed a layer of intrastromal tissue utilizing a microkeratome and called this procedure “in situ keratomileusis”. However, the results of the procedure performed with mechanical devices were not entirely satisfactory [2, 3].

Hintergrund: Diese klinische Studie berichtet die 1-Jahres-Ergebnisse der Small-Incision-Lentikel-Extraktion (SMILE) zur Korrektur der Myopie. Methodik: In der ersten prospektiven Zulassungsstudie wurden 91 Augen mit der SMILE-Technik operiert und die Ergebnisse nach 6 Monaten publiziert. In der damaligen OP-Technik wurde das intrastromale Lentikel sowie zwei 4 mm grose Eroffnungsinzisionen mit dem VisuMax-Femtosekundenlaser (Carl Zeiss Meditec, Jena) geschnitten und anschliesend dieser manuell ohne Anheben eines Flaps uber eine dieser Inzisionen entfernt. 55 Augen von 33 Patienten unterzogen sich freiwillig einer Nachuntersuchung nach 12 Monaten. Die Untersuchungsparameter waren subjektive und objektive Refraktion, s. c. und c. c. Visus, sowie eine Spaltlampenuntersuchung mit Erfassung von Spatkomplikationen. Ergebnisse: 55 Augen von 33 Patienten konnten fur die freiwillige Nachuntersuchung rekrutiert werden. Das spharische Aquivalent vor der Operation lag bei − 4,66 (± 1,75) dpt; bei der 1-Jahres-Kontrolle wurden − 0,11 (± 0,42) dpt festgestellt. Eine signifikante Veranderung gegenuber den Werten nach 6 Monaten wurde nicht gefunden. Die unkorrigierte Sehscharfe war vom praoperativen s. c. Visus 0,1 (± 0,06) auf postoperativ Visus 1,02 (± 0,3) angestiegen. Bei einem Auge wurde ein Visusverlust von mehr als 2 Zeilen aufgrund einer Hornhautrubung nachgewiesen. Bei allen anderen Probanden wurden keine Spatkomplikationen gefunden. Schlussfolgerung: Die Ein-Jahres-Ergebnisse aus der weltweit ersten Kohorte des neuen OP-Verfahrens sind ermutigend gut. Insbesondere die Stabilitat der refraktiven Korrektur des SMILE-Verfahrens ist uberzeugend.

Purpose To evaluate the 5-year results of femtosecond laser–assisted refractive lenticule extraction (ReLEx-FLEx) for the treatment of myopia and myopic astigmatism. Setting Departments of Ophthalmology, Helios Klinikum Erfurt, Erfurt, and Phillips Universitat Marburg, Marburg, Germany. Design Prospective clinical trial. Methods This was a follow-up of a prospective study that evaluated the first patients treated with refractive lenticule extraction, in which a flap and a refractive lenticule of intrastromal corneal tissue were simultaneously cut using a 200 kHz Visumax femtosecond laser system. Thereafter, the lenticule was manually removed and the flap repositioned. The main outcome measures were the uncorrected and corrected distance visual acuities, objective and manifest refractions, slitlamp examination findings, and side effects after 5 years. Results Forty-one of 108 eyes in the original treatment group were available for a reexamination. Five years postoperatively, 100% of eyes were within ±1.00 diopter (D) of the intended correction and 73% were within ±0.50 D. By 5 years, no eye had lost 2 or more Snellen lines and 1 eye had lost 1 Snellen line. The mean regression was 0.07 D. Conclusion Long-term data indicate that refractive lenticule extraction is an effective and safe procedure for the treatment of myopia and myopic astigmatism and has excellent stability. Financial Disclosure No author has a financial or proprietary interest in any material or method mentioned.

Hintergrund: Ein wichtiger Erfolgsparameter bei der refraktiven Hornhautchirurgie zur Myopiekorrektur ist die Langzeitstabilitat der Korrektur. Gewebeparameter, welche die Stabilitat und damit die Regression beeinflussen, lassen sich nur schwer untersuchen. Durch das ReLEx®flex-Verfahren, bei dem Hornhautlentikel mit einem Femtosekunden-Laser (fs-Laser) geschnitten und dann chirurgisch entfernt werden, besteht erstmals die Moglichkeit, gesundes humanes Hornhautgewebe fur eine weitere Untersuchung zu gewinnen. Unter Einsatz der Elektronenmikroskopie wurden die Gewebeparameter der entnommenen Lentikel analysiert, um mogliche Beziehungen zwischen der Hornhautbeschaffenheit und der Stabilitat refraktiver Ergebnisse zu untersuchen. Zusatzlich wurden die Auswirkungen von vorherigem Kontaktlinseneinsatz (CL) auf die Stabilitat der refraktiven Ergebnisse untersucht. Patienten und Methoden: 19 Lentikel von 11 Patienten (Alter 24–56 Jahre; 8 w, 3 m) wurden fur die Elektronenmikroskopie prapariert. Die zentralen Bereiche der Praparate wurden fotografiert und der Abstand zwischen den Kollagenfasern sowie ihr Durchmesser digital erfasst. Mittels ANOVA-Analyse wurde die pra- und postoperative Brechwertstabilitat mit der Tragezeit von Kontaktlinsen, dem Faserdurchmesser und dem Variationskoeffizienten des Faserabstands korreliert. Ergebnisse: 14 von 19 Lentikeln stammten von Patienten, die praoperativ Kontaktlinsen getragen hatten. Praoperatives Tragen von Kontaktlinsen beeinflusste die postoperative Regression deutlich: Je langer die Patienten Kontaktlinsen trugen, desto groser war die Regression in Richtung Myopie (p = 0,01). Auch die morphologischen Parameter Faserdurchmesser (p = 0,09) und Variationskoeffizienten des Faserabstands (p = 0,07) hatten einen Einfluss auf die Regression. Schlussfolgerung: Verlangertes Tragen von Kontaktlinsen und Veranderungen in den morphologischen Parametern beeinflussen die Stabilitat der Ergebnisse nach refraktiver Hornhautchirurgie. Obwohl die pathophysiologischen Beziehungen zwischen dem Tragen von Kontaktlinsen, den morphologischen Parametern der Kornea und der Brechwertstabilitat bisher kaum bekannt sind, konnten diese Ergebnisse moglicherweise als Prognosemarker fur die postoperative Refraktion nach ReLExflex genutzt werden.

This prospective study focused on the results of a novel method for refractive correction, femtosecond lenticule extraction (ReLEx®) in hyperopia, and reports the first 47 eyes. In 47 hyperopic eyes (26 patients), both a flap and a lenticule of intrastromal corneal tissue were simultaneously cut utilizing the Carl Zeiss Meditec AG (CZM) 200 kHz VisuMax® femtosecond laser system. Thereafter, the lenticule was manually removed and the flap repositioned. Forty two out of 47 hyperopic eyes of the treatment group completed the final 9-month follow-up. The patients mean age was 42.3 (±9.0) years. Their mean preoperative spherical equivalent (SE) was +2.8 (±1.3) D. UCVA and BSCVA after 9 months, objective and manifest refraction, as well as slit-lamp examination and side-effects were evaluated. Nine months postoperatively, 64 % of eyes treated were within ±1.0 D, and 38 % of eyes within ±0.5 D of intended correction. One of 47 eyes (2.1 %) lost more than 2 Snellen lines; none of the eyes had a UCVA less than 0.5. However, stability was less impressive when compared to ReLEx® for the correction of myopia. First data suggest that ReLEx® is a feasible and effective procedure for treatment of hyperopia. Further research is needed to improve predictability and effectiveness of the procedure for the correction of hyperopia.

In a single-blinded study, optical side-effects of a potential femtosecond (fs)-laser therapy in presbyopic human lenses were tested. Simulation of this therapy was carried out by applying fs-laser patterns into standard contact lenses (CL). In the first part of the study, the influence of the numerical aperture on optical side-effects was investigated by comparing a typical fs-LASIK configuration to a fs-presbyopia treatment (n = 11). The second part focused on a possible improvement of visual performance by comparing a regular grid pattern to a randomly chosen spacing of the laser spots (n = 16). Visual acuity was measured with ETDRS charts, contrast sensitivity with F.A.C.T. charts and mesopic vision with Mesotest II. Forward scattered light was measured with the C-Quant (both instruments: Oculus Optikgerate GmbH, Germany). A questionnaire detected subjective quality of vision. Differences between laser-treated and untreated CL and among the modifications were analyzed. The laser-treated and standard CL indicated no significant difference in visual acuity, contrast sensitivity and mesopic vision without glare. While wearing modified lenses with a regular grid, quality of vision decreased significantly by means of mesopic vision with glare and subjective straylight. These modifications also caused an impairment of subjective quality of vision. In contrast, there was no significant difference between the random pattern and standard CL. The increase of optical side-effects was reproducibly dependent on the geometry of the laser-structure. A randomized grid induced the least limitation. The study results are useful for planning possible laser-patterns in fs-laser therapy of the presbyopic lens.

The objective of this paper is to create a new accommodating opto-mechanical model of the aging human eye for basic optical and mechanical simulations. This model can be used for the evaluation and simulation of laser treatments of presbyopia or other diseases of the human eye. The presented eye model contains a lens, structured by cortex and nucleus, which is mechanically simulated by a finite element model (FEM) with the program ANSYS. The model is orientated on physiologically measured values describing the dependences of geometrical lens parameters on age and accommodation. The results of this mechanical simulation are used as input for a complete optical eye model, implemented in the software ZEMAX. The optical performance of the model corresponds with clinical data. The resulting joined opto-mechanical model describes the accommodation of the aging eye. Established optical eye models like those of Koretz et al., Dubbelman et al. and Norrby are used as reference to show the level of correspondence between them and the eye model presented here. Due to a different approach, the presented model makes it possible to explain the changes in the geometric optical parameters during accommodation; for this purpose it uses the changes caused by the stiffness and the effecting forces in the mechanical lens model. The model is suitable for different optical simulations especially for theoretical investigations to develop treatment methods of presbyopia. The state of presbyopia is controlled by the stiffness choice in the mechanical lens model.

To investigate the long-term stability and possible cataractogenesis after femtosecond laser treatment of the crystalline lens.The crystalline lenses of ten Göttingen minipigs® underwent femtosecond laser treatment. During a subsequent 1-year follow-up, the pigs were monitored by means of slit-lamp examination of the anterior segment and Scheimpflug imaging of the lens.No laser-induced cataractogenesis was observed during the 1-year follow-up. The laser pattern showed a stable appearance under all examination devices.Femtosecond laser treatment seems to be no trigger for cataract formation. Moreover, the long-term stability of the laser pattern makes it suitable for applications such as presbyopia treatment.

Background This clinical trial is focussed on the 12-month results of a new method for refractive correction, femtosecond lenticule extraction (FLEx). Patients and methods In a prospective 6-month study 108 eyes were treated in Erfurt and Marburg. Both a flap and a lenticule of intrastromal corneal tissue were simultaneously cut utilising the Carl Zeiss Meditec AG (Jena, Germany) VisuMax femtosecond laser system. Thereafter, the lenticule was manually removed and the flap repositioned. 31 patients all treated in Erfurt volunteered for a 12-month follow-up. UCVA and BSCVA after 12 months, objective and manifest refraction as well as slit-lamp examination and late side effects were documented. Results 62 eyes of 31 patients were examined in this study. The spherical equivalent before surgery was -4.81 (± 1.16) D; after 12 months -0.15 (± 0.46) D were manifest. No significant change was observed after the 6 months control. Starting with UCVA of 0.12 (± 0.09) before surgery UCVA was 1.10 (± 0.26) after 12 months. In one patient corneal ectasia was diagnosed. All other patients did not have any late side effects. Conclusion The stability of the correction of myopic astigmatism with the FLEx procedure is very good. The fact that one patient presented with a corneal ectasia demonstrates that one general problem of refractive corneal surgery persists with this new fs technology.

Aim This 6 month prospective multi-centre study evaluated the feasibility of performing myopic femtosecond lenticule extraction (FLEx) through a small incision using the small incision lenticule extraction (SMILE) procedure. Design Prospective, non-randomised clinical trial. Participants Ninety-one eyes of 48 patients with myopia with and without astigmatism completed the final 6 month follow-up. The patients9 mean age was 35.3 years. Their preoperative mean spherical equivalent (SE) was −4.75±1.56 D. Methods A refractive lenticule of intrastromal corneal tissue was cut utilising a prototype of the Carl Zeiss Meditec AG VisuMax femtosecond laser system. Simultaneously two opposite small ‘pocket’ incisions were created by the laser system. Thereafter, the lenticule was manually dissected with a spatula and removed through one of incisions using modified McPherson forceps. Main outcome measures Uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA) after 6 months, objective and manifest refraction as well as slit-lamp examination, side effects and a questionnaire. Results Six months postoperatively the mean SE was −0.01 D±0.49 D. Most treated eyes (95.6%) were within ±1.0 D, and 80.2% were within ±0.5 D of intended correction. Of the eyes treated, 83.5% had an UCVA of 1.0 (20/20) or better, 53% remained unchanged, 32.3% gained one line, 3.3% gained two lines of BSCVA, 8.8% lost one line and 1.1% lost ≥2 lines of BSCVA. When answering a standardised questionnaire, 93.3% of patients were satisfied with the results obtained and would undergo the procedure again. Conclusion SMILE is a promising new flapless minimally invasive refractive procedure to correct myopia.

Despite an increasing popularity of the ReLEx® procedure, it still has some drawbacks. One of them is the absence of software for the current VisuMax® laser to treat hyperopia. Indeed, the idea of “all-in-one surgery” can only become a true femtosecond-laser-alone procedure, if all refractive errors can be treated without excimer laser.

High satisfaction after refractive surgery fundamentally depends on the long-term refractive stability. Several factors have an influence on postoperative refractive results, i.e. long-term stability of preoperative refraction, preoperative difference between subjective and objective refractive measurements. Individual tissue characteristics might have an influence on postoperative results as well. However, there are no options up to now to evaluate tissue parameters preoperatively.

Corneal resectional refractive procedures for the correction of myopia were pioneered by Barraquer and Ruiz [1]. They removed a layer of intrastromal tissue utilizing a microkeratome and called this procedure “in situ keratomileusis.” However, the results of the procedure performed with mechanical devices were not entirely satisfactory [2, 3].

Die Presbyopie ist die bei weitem häufigste Fehlsichtigkeit, die bis heute keiner befriedigenden dauerhaften Korrektur zugänglich ist. Alle bisherigen Versuche, eine operative Therapie der Presbyopie zu entwickeln, haben bislang zu keiner klinisch etablierten Methode geführt. Im Tierversuch gibt es Anhaltspunkte für eine Möglichkeit, mittels Niedrigenergie-Femtosekundenlaser-Impulsen (fs-Laser) die Elastizitätsveränderungen der Augenlinse therapeutisch zu beeinflussen. Mit fs-Laserimpulsen können innerhalb des Linseninneren sowohl im Tierversuch als auch bei menschlichen Linsen Schnitte erzeugt werden, die die Elastizität der Linse erhöhen. Durch diese Konzepte zur Behandlung der Presbyopie mittels fs-Laser-Impulsen entsteht die Forderung nach komplexeren Augenmodellen, die neben den optischen auch mechanische Eigenschaften des Auges modellieren. Diagnostische Instrumente zur umfassenden objektiven Bewertung der dynamischen Refraktionseigenschaften des Auges, um die Presbyopiestufe zu charakterisieren und spätere Therapieerfolge objektiv zu bewerten, werden entwickelt. Eine nichtinvasive Behandlung der Altersweitsichtigkeit könnte möglich werden.

When Hermann von Helmholtz invented the direct ophthalmoscope in 1850, he opened the door to a non-invasive visualization of human microcirculation in vivo at the retina (Figure 1). Only a few years later, on 4 September 1864, a young man presented a talk on ‘The blood vessels of the human eye’ at the Heidelberg Ophthalmology Congress—his namewas Theodor Leber, and today, he is regarded as one of the founders of ophthalmic research. Only relatively minor changes have been made subsequently to Leber’s original anatomical drawings of the ocular vasculature [1]. In 1904, W. M. Bayliss was the first to describe the myogenic constriction of arterioles when transmural pressure is elevated [2]. This so-called ‘Bayliss effect’ is a central mechanism of the autoregulation to maintain blood flow in an organ despite variations in perfusion pressure. The kidney is the classical organ in which autoregulation of blood flow with changes in perfusion pressure has been demonstrated [3,4]. The retina provides an opportunity for the in vivo investigation of a part of human circulation. It has been shown that blood flow in the human retina is autoregulated [5], and with modern technology, the retina offers the unique chance to measure the ‘Bayliss effect’ on a non-invasive basis in human retinal arterioles [6]. As it is generally accepted that the retinal vessels have no functioning autonomic innervation beyond the lamina cribrosa, this autoregulation occurs in response to changes in perfusion pressure or in response to metabolic stimuli. The mammalian retina has been found to possess an unusually high rate of glycolysis [7] and oxygen consumption [8], with this activity fuelling the active transport processes that maintain the ionic gradients necessary for visual transduction and electrical activity. As it is widely accepted that cerebral blood flow is spatially and temporally coupled to brain function and metabolism [9], the same neurovascular coupling was postulated for the retina [10]. Different measuring methods have been developed to quantify ocular perfusion. They have profoundly changed our understanding of the regulation and dysregulation of perfusion of the eye, and given new insights into the pathogenesis of ocular diseases. These findings were brought to the attention of ophthalmologists, and in clinical practice and research, use of these technologies was limited to the ophthalmic community. However, some devices have demonstrated their functionality in the hands of neurologists and diabetologists. The Dynamic Retinal Vessel Analyzer (DVA, Imedos, Jena, Germany) consists of a modified CCD camera fitted to a fundus camera (Carl Zeiss Meditec, Jena, Germany) (Figure 2) [11]. In ‘static vessel analysis’, a single fundus picture is used to measure arterial and venous vessel diameters around the optic nerve and calculate the central arterial equivalent, the central retinal venous equivalent and the arterial-to-venous diameter ratio (AVR) [12]. Large epidemiological studies showed evidence that these values are indicators for cardioand cerebrovascular events [13]. In ‘dynamic vessel analysis’, the instrument measures vessel diameter in relation to time and local position along a vessel in real time continuously 25 times per second. The examination of function and individual capacities of vessel segments along the vessel is based on the fact that the vessel diameters are the essential adjusting elements of autoregulation. As an additional stimulation test for vessel function, the DVA interrupts the green measuring light and generates a flicker light with a frequency of 12.5 Hz with a bright-to-dark ratio of 25:1. The diameter responses can be recorded, and the dilation of vessel diameter is used as a functional diagnostic parameter for the endotheliumderived vasodilation. Since autoregulation is a generic term for different local feedback control systems, superimposed on each other vessel behaviour ranges from dynamic vessel changes within seconds (flicker response) to minutes (metabolic response). Although a general outline of the circulation and its autoregulation is useful for haemodynamic purposes, special circulations exist to meet the functional needs of individual organs. In many diseases, the kidney and the eye are linked—only recently in this journal, an editorial comment reviewed the linkage between dense-deposit disease and retinal drusen [14]. In type 1 and type 2 diabetes, patients

• Background: Pooled intravenous gammaglobulin (IVIg) was reported to be effective in the treatment of Wegener's granulomatosis (WG). No reports have been made on the effects of this new treatment on ocular manifestations of WG. • Method: IVIg treatment was given to two patients suffering from WG with ocular involvement after several other treatment regimes had failed. • Results: Although the systemic disease was under control, the ocular symptoms of both patients worsened during and after IVIg treatment. In one case an adverse effect consisting of retinal vasculitis was noted on two occasions. • Conclusion: Although beneficial effects of IVIg treatment on WG have been previously described, the two cases with ocular involvement presented here did not reveal any positive response. Paradoxical and unpredictable reactions cannot be ruled out. Thus, patients treated with IVIg should be closely surveyed by an ophthalmologist.

Patienten und Myopia magna stellen eine Problemgruppe in der Kataraktchirurgie dar. Neben unterschiedlichen Zahlenangaben insbesondere bezuglich der retinalen Komplikationsrate bestehen Fehlermoglichkeiten bei der Kunstlinsenberechnung. Methode: In einer retrospektiven Studie wurden die Daten von 97 Augen von 60 hochmyopen Patienten ausgewertet. Eingeschlossen wurden nur Augen mit Bulbuslangen >26 mm. Alle Augen waren einer Kataraktextraktion mit Hinterkammerlinsenimplantation unterzogen worden. Analysiert wurden die Visusergebnisse, die Vorhersage der postoperativen Refraktion und die Komplikationsrate. Ergebnisse: Der praoperative Visus stieg von 0,18 im Mittel um 5 Log-Einheiten auf 0,46 an. Im spharischen Aquivalent wurde eine Reduzierung der Myopie von –13,6 dpt auf –3,0 dpt erreicht. 66% der Patienten lagen ±1 dpt an der vorhergesagten Refraktion, 86% im Bereich ±2 dpt. Im Nachbeobachtungszeitraum von durchschnittlich 14,8 Monaten trat keine Pseudophakieamotio auf. Schlusfolgerung: Bei befriedigender Vorhersagegenauigkeit der postoperativen Refraktion sind die funktionellen Ergebnisse gut. Unsere Zahlen unterstutzen die Studien, die von einer nur geringgradig erhohten retinalen Komplikationsrate berichten.

Purpose: To examine age-related anatomical changes of the ciliary sulcus and the implication of these changes for placement of posterior chamber intraocular lenses (IOLs). Setting: Department of Ophthalmology, University of Heidelberg, Germany. Methods: In this study, 64 human autopsy eyes from 38 donors were divided by age into six groups from younger than 40 years (Group 1) to 80 years and older (Group 6) in 10 year increments. External diameter, capsular bag size, and lens thickness were determined for each eye. The horizontal and vertical diameters of the ciliary sulcus were measured and histological sectioning, staining, and light microscopy performed. Results: The external diameters of the eyes showed no age correlation; the lenses exhibited the expected increase in thickness with age. The mean vertical diameter of the ciliary sulcus decreased in all age groups from 12.02 mm ± 0.12 (SD) to 10.71 ± 0.91 mm and the mean horizontal diameter, from 11.36 ± 0.24 mm to 10.33 ± 0.76 mm. Statistical analysis confirmed the overall significance (P < .05) of the differences among age groups. Conclusion: The ciliary sulcus became smaller with age. This might affect the size of sulcus-implanted IOLs and should be noted for transsclerally sutured IOLs.

To examine the use of a modified Hartmann–Shack wave front aberrometer (WASCA; Carl Zeiss Meditec AG, Germany) to measure objective stray light caused by forward light scatter from the anterior segment of the human eye. HELIOS Klinikum Erfurt/Institute of Biomedical Engineering and Informatics, Ilmenau University of Technology, Germany. Scatter parameters, including the Michelson contrast and cross-sectional area at half height (CAHM) were examined in Hartmann–Shack images from ten subjects with a cataract in one eye and an intraocular lens (IOL) in the other. The parameters were compared between each eye. Light scatter was then measured in 40 healthy subjects (age range, 23–75 years) with spherical ametropia ranging from −0.25 to 0.25 diopters. The subjects were divided into three age groups; 23–35, 36–50, and 51–75 years. Light scatter was also measured using four alternative methods. CAHM and contrast were significantly different between the eyes with the cataract and the IOL (P = 0.007 and P = 0.004, respectively). CAHM (r = 0.557, P

Purpose: To analyze the postoperative outcome and complication rate following cataract extraction because of post-traumatic lens opacification. Setting: University medical center. Methods: A retrospective analysis was done of 148 eyes with traumatic cataracts operated on between 1978 and 1992. Age, sex, traumatic sequelae, surgical strategies, and postoperative complications were reviewed for all eyes. Results: In 85 eyes, Group A, a history of blunt trauma could be ascertained. In 63 eyes, Group B, there had been a penetrating injury. Secondary glaucoma was observed more frequently in patients with blunt trauma. A posterior chamber intraocular lens was implanted in 85% of Group A eyes and in 67% of Group B eyes. Mild or moderate postoperative complications occurred in 15% of all cases. Postoperatively, the incidence of glaucoma remained unchanged. Visual acuity improved in 90% of eyes. Ten percent of eyes did not benefit from cataract surgery because of severe traumatic involvement of the retina or optic nerve. Conclusions: In this study, a majority of eyes with traumatic cataract were safely rehabilitated with posterior chamber lens implantation. Visual acuity improved in 90% of eyes; complications were seen in 15%.

Purpose To evaluate the visual outcome of refractive lenticule extraction in eyes with myopic astigmatism using the Visumax femtosecond laser. Setting Department of Ophthalmology, HELIOS Klinikum Erfurt, Erfurt, Germany. Design Nonrandomized clinical trials. Methods The data set encompassed treatments of sphere and astigmatism. Vector analysis was performed to study the astigmatic results at each follow-up visit at 1 week and 1, 3, and 6 months. Visual outcomes were analyzed for the 6-month follow-up period. Results The data evaluated was a complete set of refractive data of 182 treatments (87 left eyes, 95 right eyes). Efficacy, predictability, and safety with regard to astigmatic correction were comparable to the results with U.S. Food and Drug Administration–approved excimer lasers. At 6 months, the mean error ratio was 0.68 ± 0.75 (SD) and the mean correction ratio was 1.11 ± 0.69. There was slight astigmatic undercorrection (approximately 10%) over time. The residuum of the linear regression analysis of the predictability plot was approximately 0.4 diopter. Ninety-six percent of the eyes had a corrected distance visual acuity (CDVA) of 20/20 or better; no eye had a CDVA worse than 20/32. Conclusion Femtosecond refractive lenticule extraction is an effective procedure for correcting myopic astigmatism. Financial Disclosure Drs. Sluyterman v. L. and Russmann are employees of and Drs. Blum and Kunert are investigators for Carl Zeiss Meditec AG, Jena, Germany.

Background Chronic heart failure (CHF) is the leading cause of hospitalization and death in industrialized countries. CHF is frequently associated with humoral and metabolic disturbances, including reduced bioavailability of the important signalling molecule nitric oxide (NO), which has vasodilating properties. Several studies reported high plasma levels of asymmetrical NG, NG-dimethyl-L-arginine (ADMA), an endogenous inhibitor of NO production, in CHF, contributing to endothelial dysfunction. The Dynamic Vessel Analyzer (DVA) enables dynamic analyses of retinal vessels. NO is a mediator of retinal vasodilator response to flicker light. Reduced response of retinal arterioles to flicker light may be an attractive technique to non-invasively assess endothelial dysfunction. The aim of the study was to test the hypothesis that retinal vessel response to flicker light is reduced in patients with CHF and correlates inversely with serum ADMA levels.

Aim To produce two-dimensional reconstruction maps of the subepithelial nerve plexus (SEP) in living cornea by in vivo laser scanning confocal microscopy in real time. Methods In vivo confocal laser scanning microscopy (Heidelberg Retinal Tomograph II in conjunction with the Rostock Cornea Module) was performed on normal eyes (n=6) and eyes after laser-assisted in situ keratomileusis (LASIK) (n=4). Source data (frame rate 30 Hz) were used to create large-scale maps of the scanned area in Automatic Real Time composite mode. The algorithm aligns single live images onto the previously mapped composite image using landmark feature-based image processing. Results Real-time mapping of the SEP was performed on a large-scale area up to 3.2×3.2 mm (3072×3072 pixels) in healthy subjects and in post-LASIK patients. Two-dimensional structures of the SEP were imaged in all 10 eyes. Mapping quality as well as acquisition time were dependent on subject compliance and examiner experience. Conclusion The described method permits real-time in vivo mapping of the SEP, thus providing the necessary basis for statistically robust conclusions concerning morphometric plexus alterations.

To determine the surface characteristics of human corneal lenticules after femtosecond laser surgery for myopia. The Carl Zeiss Meditec AG VisuMax® femtosecond laser system was used for refractive correction called Femtosecond Lenticule Extraction on 24 myopic eyes. The surface regularity on the refractive corneal lenticules recovered was evaluated by assessing scanning electron microscopy images using an established scoring system. Three different energy levels 150, 180, and 195 nJ were compared (n = 8 in each group). Surface irregularities were caused by tissue bridges, cavitation bubbles, or scratches. The surface regularity index (R2 = 0.74) decreased as pulse energy increased. The average surface regularity score obtained was 7.5 for 150 nJ, 7.25 for 180 nJ, and 6.25 for 195 nJ. The human corneal lenticules created with the VisuMax® femtosecond laser system are of predictable, good-quality surface. This study shows the influence of pulse energy on surface regularity in human eyes. Further studies should focus on optimization of laser parameters as well as surgical technique to improve the regularity of the corneal stromal bed and so make the advantages of the femtosecond laser technology over conventional techniques clearer in the future.

Purpose: To determine the surface characteristics of porcine corneal lenticules after Femtosecond Lenticule Extraction. Methods: The Carl Zeiss Meditec AG VisuMax® femtosecond laser system was used to create refractive corneal lenticules on 10 freshly isolated porcine eyes. The surface regularity on the corneal lenticules recovered was evaluated by assessing scanning electron microscopy images using an established scoring system. Results: All specimens yielded comparable score results of 5–7 points (SD = 0.59) per lenticule (score range minimum 4 to maximum 11 points). Surface irregularities were caused by tissue bridges, cavitation bubbles or scratches. Conclusion: The Femtosecond Lenticule Extraction procedure is capable of creating corneal lenticules of predictable surface quality. However, future studies should focus on the optimization of laser parameters as well as surgical technique to improve the regularity of the corneal stromal bed.

To report the 6-month results of a new method of refractive correction, femtosecond lenticule extraction (FLEx), and the preliminary outcomes in the first 108 eyes.In this prospective study, a flap and a lenticule of intrastromal corneal tissue were cut simultaneously using a femtosecond laser. Thereafter, the lenticule was removed manually and the flap repositioned. One hundred and seven of 108 myopic eyes of 56 patients in the treatment group completed the final 6 months of follow-up. The patients' mean age was 35 years. The preoperative mean spherical equivalent (SE) was -4.59 +/- 1.3 diopters (D). The uncorrected visual acuity and the best spectacle-corrected visual acuity after 6 months, objective and manifest refractions, results of slit-lamp examination, the side effects, and the responses to a questionnaire are reported.Six months postoperatively, the mean SE was -0.19 +/- 0.47 D; 98.1% of treated eyes were within +/-1.0 D, and 74.8% of eyes within +/-0.5 D of the intended correction. Eight (7.4%) of 108 eyes lost one line of Snellen VA, one (0.9%) eye lost two Snellen lines, 46 eyes (43%) gained one line, ten eyes (9.3%) gained two Snellen lines, and the VA remained unchanged in 42 (39.3%) eyes. The patient responses to a standardized questionnaire indicated that 97.1% of patients were satisfied with the obtained results and would undergo the procedure again.FLEx appears to be a safe and promising corneal refractive procedure for correcting myopia.

Purpose: To assess the efficacy, safety, and predictability of the VisuMax femtosecond laser (Carl Zeiss Meditec). Methods: In a prospective, multicenter clinical trial, 32 eyes of 17 patients underwent LASIK and flap creation with the VisuMax femtosecond laser and ablation with the MEL 80 excimer laser (Carl Zeiss Meditec). Mean patient age was 35 years (range: 23 to 52 years). Mean preoperative spherical equivalent refraction was −4.04±1.39 diopters (D) (range: −1.50 to −7.25 D), and the planned flap thickness was 110, 120, 140, and 150 µm. Results: At the 3-month postoperative examination, all eyes had best spectacle-corrected visual acuity of 20/25 and uncorrected visual acuity (UCVA) of 20/40; 91% of eyes reached UCVA of 20/20 or better. Ninety-four percent of eyes were within ±0.50 D of the planned correction. Complications were limited to one case of suction loss, and no other adverse events were noted at 3 months. The flaps were planar and the mean achieved central flap thickness was 118±9.2 µm for an attempted thickness of 120 µm. Conclusions: The investigators achieved LASIK outcomes exceeding the US Food and Drug Administration guidelines for refractive procedures in this series of myopic eyes using the VisuMax femtosecond laser and MEL 80 excimer laser. The curved contact lens of the applanation glass combined with low suction permitted continuous fixation during treatment. [ J Refract Surg. 2009;25:350–356.]

Investigation of retinal vasodilation under flickering light is considered a dynamic analysis in contrast to the static analysis of retinal vessel equivalents (mean retinal vessel diameter). We investigated whether dynamic analysis apart from the static one in type 1 diabetic patients without diabetic retinopathy with well-controlled diabetes could lead to additional information regarding retinal autoregulation.18 normotensive type 1 diabetic patients without retinopathy and 19 healthy subjects were included. Diameter of retinal vessels was measured with Dynamic Vessel Analyzer. Changes in vasodilation are expressed as percent change over baseline values.HbA(1c) was 7.5+/-1.0% in diabetic patients. In arteries, the response to flicker was diminished in diabetic patients compared to healthy volunteers (p0.023). In patients flicker stimulation increased arterial diameter by +2.7% in contrast to +4.4% in controls. Venous vessel diameter increased by +3.1% in diabetic individuals and by +5.3% in the control group (p0.002). There were no differences in static analysis between both groups.Diabetic patients without retinopathy with relatively good glycemic control show reduced retinal vasodilation after flicker indicating dysfunction in retinal autoregulation. The use of provocation test in conjunction with static analysis could lead to additional information regarding abnormal retinal autoregulation.

Purpose: To investigate the position and stability of the crystalline lens after application of a suction device containing a contact lens and a vacuum unit for the treatment of presbyopia using a femtosecond laser. Methods: Twenty presbyopic (44.4±4.3 years) and 5 pre-presbyopic patients (31.6±3.8 years) were included. The anterior chamber depth, along with the position of the lens, was investigated before and after application of the suction device with optical coherence tomography (Visante OCT; Carl Zeiss Meditec AG). The type of suction device is routinely used for femtosecond LASIK with the VisuMax laser (Carl Zeiss Meditec AG). Results: In both groups, there was a reduction in anterior chamber depth of approximately 700 µm due to the suction device, and the anterior chamber depth achieved was stable. The maximum variation was 160 µm. At the periphery of the crystalline lens, there were movements up to 310 µm axially and 470 µm laterally. Conclusions: The study proves that once the suction device has been applied, the crystalline lens is stable enough to undergo presbyopic laser therapy. However, the reduction in anterior chamber depth induced by the suction device showed significant individual variation. The exact position of the lens should therefore be measured immediately before laser surgery. [ J Refract Surg . 2009;25:1005–1011.]