von Fiona Niedermayer ; Kathrin Wolf ; Siqi Zhang ; Marco Dallavalle ; Nikolaos Nikolaou ; Lars Schwettmann ; Peter Selsam ; Barbara Heidi Hoffmann ; Alexandra Schneider ; Annette Peters
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
Online first article, published online 21 Jun. 2023 ; Gesehen am 04.03.2024
The European Environmental Noise Directive highlights public participation in the development and review of noise action plans. Considering unequal participation opportunities, determinants of public civic engagement are crucial. We conceptualised these determinants to arise from four components: (1) noise exposure, (2) environmental resources, (3) engagement-specific cognitions, and (4) general cognitions and emotions. We aimed to classify intention for civic engagement in a population-based sample from the German KORA study in the Augsburg region by using Conditional Inference Trees (CIT) with variables attributed to the four components (N = 3,743, 43–92 years). The “engagement-specific cognitions”-CIT showed the highest prevalence of civic engagement intention resulting from interactions between subjective norm (expecting positive feedback from significant others), self-efficacy (having confidence to engage), and knowledge of noise abatement planning (70.6% as compared to the sample average (11.2%)). To promote equitable decision-making, participation might benefit from focusing on residents’ cognitive-behavioural processes.
Journal of environmental planning and management London : Taylor & Francis, 1992 2023 (21. Juni), insgesamt 34 Seiten Online-Ressource
von Sonja K. Eilts ; Johanna M. Pfeil ; Broder Poschkamp ; Tim Ulrich Krohne ; Nicole Eter ; Teresa Barth ; Rainer Guthoff ; Wolf A. Lagrèze ; Milena Grundel ; Marie-Christine Bründer ; Martin Busch ; Jayashree Kalpathy-Cramer ; Michael F. Chiang ; R. V. Paul Chan ; Aaron S. Coyner ; Susan Ostmo ; Peter Campbell ; Andreas Stahl ; Stefan Schrader
von Paul Van de Heyning ; Peter Roland ; Luis Lassaletta ; Sumit Agrawal ; Marcus Atlas ; Wolf-Dieter Baumgartner ; Kevin Brown ; Marco Caversaccio ; Stefan Dazert ; Wolfgang Gstöttner ; Rudolf Hagen ; Abdulrahman Hagr ; Greg Eigner Jablonski ; Mohan Kameswaran ; Vladislav Kuzovkov ; Martin Leinung ; Yongxin Li ; Andreas German Loth ; Astrid Magele ; Robert Arndt Mlynski ; Joachim Mueller ; Lorne Parnes ; Andreas Daniel Radeloff ; Javier Gavilán
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