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Western Australia Atropine for the Treatment of Myopia (WA‐ATOM) study: Rationale, methodology and participant baseline characteristics
Author(s) -
Lee Samantha S.Y.,
Mackey David A.,
Lingham Gareth,
Crewe Julie M.,
Richards Michael D.,
Chen Fred K.,
Charng Jason,
Ng Fletcher,
Flitcroft Ian,
Loughman James J.,
AzuaraBlanco Augusto,
Logan Nicola S.,
Hammond Christopher J.,
Chia Audrey,
Truong Tan Tai,
Clark Antony
Publication year - 2020
Publication title -
clinical and experimental ophthalmology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.3
H-Index - 74
eISSN - 1442-9071
pISSN - 1442-6404
DOI - 10.1111/ceo.13736
Subject(s) - medicine , tolerability , placebo , atropine , randomized controlled trial , pediatrics , dioptre , ophthalmology , adverse effect , anesthesia , surgery , visual acuity , alternative medicine , pathology
Importance Atropine eyedrops are a promising treatment for slowing myopia progression in East Asian children. However, its effects on children in Australia, including those of non‐Asian background, have not been well‐studied. Background The Western Australia Atropine for the Treatment of Myopia (WA‐ATOM) study aims to determine the efficacy and long‐term effects of low‐dose atropine eyedrops in myopia control. This paper describes the study rationale, methodology and participant baseline characteristics. Design Single‐centre, double‐masked, randomized controlled trial. Participants Children (6‐16 years) with spherical equivalent ≤−1.50 D in each eye, astigmatism ≤1.50 D and myopia progression by ≥0.50 D/year. Methods Enrolled children were randomly assigned 2:1 to receive 0.01% atropine or placebo eyedrops. Participants are examined every 6 months during first 3 years of the study (2‐year treatment phase followed by a 1‐year washout phase), and then at a 5‐year follow‐up (2 years after the end of the washout phase). Main Outcome Measures Annual progression rate of myopia and axial length, tolerability to eyedrops and incidence and severity of unwanted effects. Results Out of 311 children who were referred, 242 were suitable for study participation, and 153 were subsequently enrolled. The baseline characteristics of enrolled participants are presented. Conclusions and Relevance Outcomes of the WA‐ATOM study will inform on the efficacy, tolerability, safety and long‐term effects of low‐dose atropine eyedrops in myopia control in Australian children. The impact of ocular sun exposure, iris colour and parental myopia on the efficacy of low‐dose atropine will also be assessed.