von Navid Farassat ; Daniel Böhringer ; Sebastian Küchlin ; Fanni E. Molnár ; Anne Schwietering ; Dorina Seger ; Martin J. Hug ; Anja-Birte Knöbel ; Sabine Schneider-Fuchs ; Gabriele Ihorst ; Bettina Kathrin Wabbels ; Christina Beisse ; Focke Ziemssen ; Frank Schüttauf ; Andrea Martina Hedergott ; Theresia Ring-Mangold ; Claudia Schuart ; Armin Wolf ; Stefanie Schmickler ; Julia Biermann ; Philipp Eberwein ; Karsten Hufendiek ; Anja Eckstein ; Gabriele Gusek-Schneider ; Michael Peter Schittkowski ; Thomas Lischka ; Wolf A. Lagrèze
Clinical trials; Medical ophthalmology; OPHTHALMOLOGY; Paediatric ophthalmology
Introduction Myopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and safety of 0.02% atropine vs placebo in a German population. - Methods and analysis AIM is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with two parallel arms. The primary objective is to assess the efficacy of atropine 0.02% eyedrops for myopia control in children of Caucasian origin. The primary outcome is the change in cycloplegic refraction after 1 year of treatment (D/year). Secondary and tertiary outcome measures comprise the change in axial length (mm/year) in children treated with 0.02% atropine compared with placebo, the myopic progression of participants treated with 0.01% compared with 0.02% atropine (D/year and mm/year), and the safety profile of both 0.02% and 0.01% atropine. Furthermore, the myopic progression 1 year after cessation of therapy with 0.02% atropine will be evaluated. Inclusion criteria are an age of 8-12 years and myopia of −1 D to −6 D with an estimated annual myopia progression of ≥0.5 D. After randomisation, patients will receive either atropine 0.02% (arm A) or placebo eye drops (arm B) in the first year of treatment. In the second year, they will continue to receive atropine 0.02% (arm A) or switch to atropine 0.01% (arm B). In the third year, they will switch to placebo (arm A) or continue with atropine 0.01% (arm B). To achieve a statistical power of 80%, the calculated sample size is 300. The trial has started in October 2021 with a planned recruitment period of 18 months. - Ethics and dissemination AIM has been approved by the Central Ethics Committee of the University Medical Center Freiburg (21-1106), local ethics committees of each participating centre and the German Federal Institute for Drugs and Medical Devices (61-3910-4044659). It complies with the Declaration of Helsinki, local laws and ICH-GCP. Results and underlying data from this trial will be disseminated through peer-reviewed publications and conference presentations. - Trial registration number NCT03865160.
BMJ open London : BMJ Publishing Group, 2011 13(2023), 4, Artikel-ID e068822, Seite 1-11 Online-Ressource
Ein genestetes Strömungsmodell der Nordsee sowie eine Matlab-Toolbox zur Berechnung Lagrangescher Trajektorien wird beschrieben. Mit diesen Modellen wird der Einfluss von Stokes Drift, Wind und Oberflächenströmungen auf die Verteilung von oberflächennahen Partikeln an den ostfriesischen Inseln untersucht. Hierbei werden theoretisch berechnete sowie aus den Modelldaten ermittelte Dragparameter für GPS-Drifter verglichen. Diese zeigen signifikante Unterschiede und unterscheiden sich insbesondere bei der Verwendung verschiedener Dragmodelle. Insbesondere Stokes Drift kann nicht zufriedenstellend durch Winddaten in küstennahen Bereichen repräsentiert werden. Modellierte und gemessene Trajektorien und Anlandungspunkte von GPS-Driftern zeigen im küstennahen Bereich eine qualitative Übereinstimmung, weichen auf längeren Zeitskalen die sie große Dynamik im Küstenbereich voneinander ab.
A nested hydrodynamic model of the North Sea, using the COAWST framework, is described. A MatLab toolbox for computing and evaluating Lagrangian trajectories via data for surface currents, winds and waves is presented. Stokes Drift, wind drag, tidal currents and numerical handling of landpoints are found significantly impacting distribution and beaching of surface drifting objects in high resolution modeling. Theoretical wind drag estimates for GPS-drifters are compared to numerical estimates based on hydrodynamic, wind and wave data. Derived and theoretical drag parameters significantly differ and vary between three different drag models. Stokes Drift is found not satisfyingly representable by wind data in nearshore areas. Results recommend individual drag parameter estimations for different models, datasets and regions. Measured drifter paths and beaching locations in nearshore areas are qualitatively represented on short time scales but are lacking on longer time scales due to highly dynamical features.
von Emmanouil Fokas ; Anke Schlenska-Lange ; Bülent Polat ; Gunther Klautke ; Gerhard G. Grabenbauer ; Rainer Fietkau ; Thomas Kuhnt ; Ludger Staib ; Thomas B. Brunner ; Anca-Ligia Grosu ; Simon Kirste ; Lutz Jacobasch ; Michael Allgäuer ; Michael Flentje ; Christoph-Thomas Germer ; Robert Grützmann ; Guido Hildebrandt ; Matthias Schwarzbach ; Wolf Otto Bechstein ; Heiko Sülberg ; Tim Friede ; Jochen Werner Christian Gaedcke ; Michael Ghadimi ; Ralf-Dieter Hofheinz ; Claus Rödel ; Frank Griesinger
von Georg Sprinzl ; Thomas Lenarz ; Rudolf Hagen ; Wolf Dieter Baumgartner ; Thomas Keintzel ; Tilmann Keck ; Herbert Riechelmann ; Astrid Magele ; Rolf Benedikt Salcher ; Hannes Maier ; Robert Arndt Mlynski ; Andreas Daniel Radeloff
von Veronika Brixner ; Gesine Bug ; Petra Pohler ; Doris Krämer ; Bernd Metzner ; Andreas Voß ; Jochen Casper ; Ulrich Ritter ; Stefan Klein ; Nael Alakel ; Rudolf Peceny ; Hans G. Derigs ; Frank Stegelmann ; Martin Wolf ; Hubert Schrezenmeier ; Thomas Thiele ; Erhard Seifried ; Hans-Hermann Kapels ; Andrea Döscher ; Eduard K. Petershofen ; Thomas H. Müller ; Axel Seltsam
von Timo Stöver ; Stefan Dazert ; Stefan K.-R. Plontke ; Sabine Maria Kramer ; Petra Ambrosch ; Christoph Arens ; Christian Stephan Betz ; Dirk Beutner ; Christopher Bohr ; Karl-Ludwig Bruchhage ; Martin Canis ; Andreas Dietz ; Orlando Guntinas-Lichius ; Rudolf Hagen ; Werner Hosemann ; Heinrich Iro ; Jens Peter Klußmann ; Andreas Knopf ; Stephan Lang ; Martin Leinung ; Thomas Lenarz ; Hubert Martin Löwenheim ; Christoph Matthias ; Robert Arndt Mlynski ; Heidi Olze ; Jonas Jae-Hyun Park ; Peter K. Plinkert ; Andreas Daniel Radeloff ; Nicole Rotter ; Claudia Rudack ; Alessandro Bozzato ; Jörg H. Schipper ; Martin Schrader ; Patrick Schuler ; Sebastian Strieth ; Boris Stuck ; Stefan Volkenstein ; Martin Westhofen ; Gregor Wolf ; Barbara Wollenberg ; Thomas Zahnert ; Johannes Zenk ; Thomas K. Hoffmann
von Timo Stöver ; Stefan Dazert ; Thomas K. Hoffmann ; Stefan K.-R. Plontke ; Petra Ambrosch ; Christoph Arens ; Christian Stephan Betz ; Dirk Beutner ; Christopher Bohr ; Karl-Ludwig Bruchhage ; Martin Canis ; Andreas Dietz ; Orlando Guntinas-Lichius ; Rudolf Hagen ; Werner Hosemann ; Heinrich Iro ; Jens Peter Klußmann ; Andreas Knopf ; Sabine Maria Kramer ; Stephan Lang ; Martin Leinung ; Thomas Lenarz ; Hubert Martin Löwenheim ; Christoph Matthias ; Robert Arndt Mlynski ; Heidi Olze ; Jonas Jae-Hyun Park ; Peter K. Plinkert ; Andreas Daniel Radeloff ; Nicole Rotter ; Claudia Rudack ; Alessandro Bozzato ; Jörg H. Schipper ; Martin Schrader ; Sebastian Strieth ; Boris Stuck ; Stefan Volkenstein ; Martin Westhofen ; Gregor Wolf ; Barbara Wollenberg ; Thomas Zahnert ; Johannes Zenk
