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Ophthalmology
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doi:10.1016/j.ophtha.2011.07.031 | How to Cite or Link Using DOI
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Atropine for the Treatment of Childhood Myopia: Safety and Efficacy of 0.5%, 0.1%, and 0.01% Doses (Atropine for the Treatment of Myopia 2)
Audrey Chia FRANZCO1, 2, Wei-Han Chua FRCSEd(Ophth), FAMS1, 2, Yin-Bun Cheung PhD3, 4, Wan-Ling Wong Mbiostat2, Anushia Lingham SRN4, Allan Fong FRCSEd(Ophth)1, 2, Donald Tan FRCS, FRCOphth1, 2, 5, ,
Purchase
1
Singapore National Eye Center, Singapore
2
Singapore Eye Research Institute, Singapore
3
Duke-NUS Graduate Medical School, Singapore
4
Singapore Clinical Research Institute, Singapore
5
Department of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
Received 5 April 2011; revised 20 July 2011; Accepted 20 July 2011. Available online: •••.. Available online 1 October 2011.
Purpose
Our previous study, Atropine for the Treatment of Myopia 1 (ATOM1), showed that atropine 1% eyedrops were effective in controlling myopic progression but with visual side effects resulting from cycloplegia and mydriasis. The aim of this study was to compare efficacy and visual side effects of 3 lower doses of atropine: 0.5%, 0.1%, and 0.01%.
Design
Single-center, double-masked, randomized study.
Participants
A total of 400 children aged 6–12 years with myopia of at least −2.0 diopters (D) and astigmatism of −1.50 D or less.
Intervention
Children were randomly assigned in a 2:2:1 ratio to 0.5%, 0.1%, and 0.01% atropine to be administered once nightly to both eyes for 2 years. Cycloplegic refraction, axial length, accommodation amplitude, pupil diameter, and visual acuity were noted at baseline, 2 weeks, and then every 4 months for 2 years.
Main Outcome Measures
Myopia progression at 2 years. Changes were noted and differences between groups were compared using the Huber–White robust standard error to allow for data clustering of 2 eyes per person.
Results
The mean myopia progression at 2 years was −0.30±0.60, −0.38±0.60, and −0.49±0.63 D in the atropine 0.5%, 0.1%, and 0.01% groups, respectively (P=0.02 between the 0.01% and 0.5% groups; between other concentrations P > 0.05). In comparison, myopia progression in ATOM1 was −1.20±0.69 D in the placebo group and −0.28±0.92 D in the atropine 1% group. The mean increase in axial length was 0.27±0.25, 0.28±0.28, and 0.41±0.32 mm in the 0.5%, 0.1%, and 0.01% groups, respectively (P < 0.01 between the 0.01% and 0.1% groups and between the 0.01% and 0.5% groups). However, differences in myopia progression (0.19 D) and axial length change (0.14 mm) between groups were small and clinically insignificant. Atropine 0.01% had a negligible effect on accommodation and pupil size, and no effect on near visual acuity. Allergic conjunctivitis and dermatitis were the most common adverse effect noted, with 16 cases in the 0.1% and 0.5% atropine groups, and no cases in the 0.01% group.