دورية أكاديمية
أعرض في EDS

Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind, multicentre, clinical trial with two parallel arms.

التفاصيل البيبلوغرافية
العنوان: Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind, multicentre, clinical trial with two parallel arms.
المؤلفون: Farassat N; Eye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Böhringer D; Eye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Küchlin S; Eye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Molnár FE; Eye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Schwietering A; Eye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Seger D; Eye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Hug MJ; Department of Pharmacy, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Knöbel AB; Clinical Trials Unit, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Schneider-Fuchs S; Clinical Trials Unit, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Ihorst G; Clinical Trials Unit, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany., Wabbels B; Department of Ophthalmology, University Hospital Bonn, Bonn, Germany., Beisse C; Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany., Ziemssen F; Department of Ophthalmology, University Hospital Leipzig, Leipzig, Germany., Schuettauf F; Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Hedergott A; Department of Ophthalmology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Ring-Mangold T; Department of Ophthalmology, Ludwig-Maximilians-University (LMU) Munich, Munich, Germany., Schuart C; Department of Ophthalmology, Medical Faculty of Otto von Guericke University Magdeburg, Magdeburg, Germany., Wolf A; Department of Ophthalmology, Ulm University Medical Center, Ulm, Germany., Schmickler S; Augen-Zentrum-Nordwest, Ahaus, Germany., Biermann J; Department of Ophthalmology, University of Muenster Medical Center, Muenster, Germany., Eberwein P; AugenCentrum Rosenheim, Rosenheim, Germany., Hufendiek K; University Eye Hospital, Hannover Medical School, Hannover, Germany., Eckstein A; Department of Ophthalmology, University Duisburg Essen, Essen, Germany., Gusek-Schneider G; Department of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany., Schittkowski M; Department of Ophthalmology, Section for Strabismus and Neuroophthalmology, University Medicine Göttingen, Göttingen, Germany., Lischka T; Department of Ophthalmology, Carl-von-Ossietzky University Oldenburg, Oldenburg, Germany., Lagrèze WA; Eye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany wolf.lagreze@uniklinik-freiburg.de.
المصدر: BMJ open [BMJ Open] 2023 Apr 20; Vol. 13 (4), pp. e068822. Date of Electronic Publication: 2023 Apr 20.
نوع المنشور: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Atropine*/therapeutic use , Myopia*/drug therapy, Humans ; Child ; Prospective Studies ; Vision Tests ; Double-Blind Method ; Ophthalmic Solutions/therapeutic use ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
مستخلص: 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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
References: Ophthalmology. 2019 Jan;126(1):113-124. (PMID: 30514630)
Br J Ophthalmol. 2016 Jul;100(7):882-890. (PMID: 26802174)
Ophthalmology. 2022 Mar;129(3):308-321. (PMID: 34627809)
Ophthalmology. 2020 Jul;127(7):910-919. (PMID: 32019700)
Lancet. 2012 May 5;379(9827):1739-48. (PMID: 22559900)
HRB Open Res. 2019 Jul 23;2:15. (PMID: 32002514)
BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884)
Ophthalmology. 2016 Feb;123(2):391-399. (PMID: 26271839)
Ophthalmology. 2006 Dec;113(12):2285-91. (PMID: 16996612)
Invest Ophthalmol Vis Sci. 2020 Apr 9;61(4):49. (PMID: 32347918)
Dtsch Arztebl Int. 2020 Dec 11;117(50):855-860. (PMID: 33612155)
J Fr Ophtalmol. 2021 Dec;44(10):1499-1504. (PMID: 34774348)
JAMA Ophthalmol. 2017 Jun 1;135(6):624-630. (PMID: 28494063)
Eur J Epidemiol. 2015 Apr;30(4):305-15. (PMID: 25784363)
Eye (Lond). 2014 Feb;28(2):142-6. (PMID: 24357836)
Ophthalmology. 2022 Mar;129(3):322-333. (PMID: 34688698)
Int Ophthalmol. 2021 Jun;41(6):2001-2008. (PMID: 33634343)
Optom Vis Sci. 2013 Dec;90(12):1467-72. (PMID: 24076540)
Br J Ophthalmol. 2020 Jul;104(7):950-955. (PMID: 31653669)
Ophthalmol Ther. 2019 Sep;8(3):427-433. (PMID: 31190219)
Br J Ophthalmol. 2022 Aug;106(8):1110-1114. (PMID: 33731364)
JAMA. 2020 Aug 11;324(6):571-580. (PMID: 32780139)
Prog Retin Eye Res. 2021 Jul;83:100923. (PMID: 33253901)
Optom Vis Sci. 2019 Aug;96(8):556-567. (PMID: 31343513)
Ophthalmologe. 2018 May;115(5):409-417. (PMID: 29110120)
Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M1-M19. (PMID: 30817825)
Cont Lens Anterior Eye. 2020 Aug;43(4):322-332. (PMID: 32331970)
Ophthalmology. 2012 Feb;119(2):347-54. (PMID: 21963266)
Eye (Lond). 2019 Jan;33(1):3-13. (PMID: 29891900)
Eye (Lond). 2014 Feb;28(2):202-8. (PMID: 24406412)
Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):2. (PMID: 33909036)
Br J Ophthalmol. 2022 Aug;106(8):1171-1176. (PMID: 33811039)
Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):6. (PMID: 33909032)
Arch Soc Esp Oftalmol (Engl Ed). 2018 Apr;93(4):182-185. (PMID: 29398233)
Clin Exp Ophthalmol. 2022 Dec;50(9):1001-1012. (PMID: 36054556)
Int Ophthalmol. 2020 Jan;40(1):255-265. (PMID: 31916062)
Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):5. (PMID: 33909033)
فهرسة مساهمة: Keywords: Clinical trials; Medical ophthalmology; OPHTHALMOLOGY; Paediatric ophthalmology
سلسلة جزيئية: ClinicalTrials.gov NCT03865160
المشرفين على المادة: 7C0697DR9I (Atropine)
0 (Ophthalmic Solutions)
تواريخ الأحداث: Date Created: 20230420 Date Completed: 20230424 Latest Revision: 20230426
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC10124292
DOI: 10.1136/bmjopen-2022-068822
PMID: 37080623
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2022-068822