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Low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of Australian children: A randomised clinical trial
BACKGROUND: To test the hypothesis that 0.01% atropine eyedrops are a safe and effective myopia‐control approach in Australian children. METHODS: Children (6–16 years; 49% Europeans, 18% East Asian, 22% South Asian, and 12% other/mixed ancestry) with documented myopia progression were enrolled into...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons Australia, Ltd
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10086806/ https://www.ncbi.nlm.nih.gov/pubmed/36054556 http://dx.doi.org/10.1111/ceo.14148 |
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author | Lee, Samantha Sze‐Yee Lingham, Gareth Blaszkowska, Magdalena Sanfilippo, Paul G. Koay, Adrian Franchina, Maria Chia, Audrey Loughman, James Flitcroft, Daniel Ian Hammond, Christopher J. Azuara‐Blanco, Augusto Crewe, Julie M. Clark, Antony Mackey, David A. |
author_facet | Lee, Samantha Sze‐Yee Lingham, Gareth Blaszkowska, Magdalena Sanfilippo, Paul G. Koay, Adrian Franchina, Maria Chia, Audrey Loughman, James Flitcroft, Daniel Ian Hammond, Christopher J. Azuara‐Blanco, Augusto Crewe, Julie M. Clark, Antony Mackey, David A. |
author_sort | Lee, Samantha Sze‐Yee |
collection | PubMed |
description | BACKGROUND: To test the hypothesis that 0.01% atropine eyedrops are a safe and effective myopia‐control approach in Australian children. METHODS: Children (6–16 years; 49% Europeans, 18% East Asian, 22% South Asian, and 12% other/mixed ancestry) with documented myopia progression were enrolled into this single‐centre randomised, parallel, double‐masked, placebo‐controlled trial and randomised to receive 0.01% atropine (n = 104) or placebo (n = 49) eyedrops (2:1 ratio) instilled nightly over 24 months (mean index age = 12.2 ± 2.5 and 11.2 ± 2.8 years, respectively). Outcome measures were the changes in spherical equivalent (SE) and axial length (AL) from baseline. RESULTS: At 12 months, the mean SE and AL change from baseline were −0.31D (95% confidence interval [CI] = −0.39 to −0.22) and 0.16 mm (95%CI = 0.13–0.20) in the atropine group and −0.53D (95%CI = −0.66 to −0.40) and 0.25 mm (95%CI = 0.20–0.30) in the placebo group (group difference p ≤ 0.01). At 24 months, the mean SE and AL change from baseline was −0.64D (95%CI = −0.73 to −0.56) and 0.34 mm (95%CI = 0.30–0.37) in the atropine group, and −0.78D (95%CI = −0.91 to −0.65) and 0.38 mm (95%CI = 0.33–0.43) in the placebo group. Group difference at 24 months was not statistically significant (p = 0.10). At 24 months, the atropine group had reduced accommodative amplitude and pupillary light response compared to the placebo group. CONCLUSIONS: In Australian children, 0.01% atropine eyedrops were safe, well‐tolerated, and had a modest myopia‐control effect, although there was an apparent decrease in efficacy between 18 and 24 months, which is likely driven by a higher dropout rate in the placebo group. |
format | Online Article Text |
id | pubmed-10086806 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley & Sons Australia, Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-100868062023-04-12 Low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of Australian children: A randomised clinical trial Lee, Samantha Sze‐Yee Lingham, Gareth Blaszkowska, Magdalena Sanfilippo, Paul G. Koay, Adrian Franchina, Maria Chia, Audrey Loughman, James Flitcroft, Daniel Ian Hammond, Christopher J. Azuara‐Blanco, Augusto Crewe, Julie M. Clark, Antony Mackey, David A. Clin Exp Ophthalmol ORIGINAL ARTICLES BACKGROUND: To test the hypothesis that 0.01% atropine eyedrops are a safe and effective myopia‐control approach in Australian children. METHODS: Children (6–16 years; 49% Europeans, 18% East Asian, 22% South Asian, and 12% other/mixed ancestry) with documented myopia progression were enrolled into this single‐centre randomised, parallel, double‐masked, placebo‐controlled trial and randomised to receive 0.01% atropine (n = 104) or placebo (n = 49) eyedrops (2:1 ratio) instilled nightly over 24 months (mean index age = 12.2 ± 2.5 and 11.2 ± 2.8 years, respectively). Outcome measures were the changes in spherical equivalent (SE) and axial length (AL) from baseline. RESULTS: At 12 months, the mean SE and AL change from baseline were −0.31D (95% confidence interval [CI] = −0.39 to −0.22) and 0.16 mm (95%CI = 0.13–0.20) in the atropine group and −0.53D (95%CI = −0.66 to −0.40) and 0.25 mm (95%CI = 0.20–0.30) in the placebo group (group difference p ≤ 0.01). At 24 months, the mean SE and AL change from baseline was −0.64D (95%CI = −0.73 to −0.56) and 0.34 mm (95%CI = 0.30–0.37) in the atropine group, and −0.78D (95%CI = −0.91 to −0.65) and 0.38 mm (95%CI = 0.33–0.43) in the placebo group. Group difference at 24 months was not statistically significant (p = 0.10). At 24 months, the atropine group had reduced accommodative amplitude and pupillary light response compared to the placebo group. CONCLUSIONS: In Australian children, 0.01% atropine eyedrops were safe, well‐tolerated, and had a modest myopia‐control effect, although there was an apparent decrease in efficacy between 18 and 24 months, which is likely driven by a higher dropout rate in the placebo group. John Wiley & Sons Australia, Ltd 2022-09-09 2022-12 /pmc/articles/PMC10086806/ /pubmed/36054556 http://dx.doi.org/10.1111/ceo.14148 Text en © 2022 The Authors. Clinical & Experimental Ophthalmology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Ophthalmologists. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | ORIGINAL ARTICLES Lee, Samantha Sze‐Yee Lingham, Gareth Blaszkowska, Magdalena Sanfilippo, Paul G. Koay, Adrian Franchina, Maria Chia, Audrey Loughman, James Flitcroft, Daniel Ian Hammond, Christopher J. Azuara‐Blanco, Augusto Crewe, Julie M. Clark, Antony Mackey, David A. Low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of Australian children: A randomised clinical trial |
title | Low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of Australian children: A randomised clinical trial |
title_full | Low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of Australian children: A randomised clinical trial |
title_fullStr | Low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of Australian children: A randomised clinical trial |
title_full_unstemmed | Low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of Australian children: A randomised clinical trial |
title_short | Low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of Australian children: A randomised clinical trial |
title_sort | low‐concentration atropine eyedrops for myopia control in a multi‐racial cohort of australian children: a randomised clinical trial |
topic | ORIGINAL ARTICLES |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10086806/ https://www.ncbi.nlm.nih.gov/pubmed/36054556 http://dx.doi.org/10.1111/ceo.14148 |
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