Original ArticleTwo-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report
Section snippets
Methods
The study design has been described previously for the LAMP study phase 1.7 In brief, children 4 to 12 years of age with myopic refraction of at least –1.0 D in both eyes, astigmatism of less than 2.5 D, and documented myopic progression of at least 0.5 D in the previous 1 year were enrolled in this double-blinded, single-center clinical trial. After excluding those with ocular diseases, those who underwent previous interventions (such as atropine, pirenzepine, orthokeratology lens, or other
Results
In total, 383 of the 438 children (87%) 4 to 12 years of age originally randomized to receive atropine 0.05%, atropine 0.025%, atropine 0.01%, or placebo once daily in both eyes in the LAMP phase 1 study were continued in this extended trial (phase 2), with 102, 91, 97, and 93 participants in the 0.05% atropine, 0.025% atropine, 0.01% atropine, and switchover group, respectively (Fig 1). The baseline characteristics of these 383 participants and the 55 participants who dropped out of the study
Discussion
This report presents the second-year results (phase 2) of the LAMP study of 4 treatment groups: 0.05% atropine, 0.025% atropine, and 0.01% atropine used daily for 2 years and switching over from using a placebo during the first year to using 0.05% atropine daily during the second year. The concentration-dependent response remained, and 0.05% atropine continued to be the most effective among 0.05%, 0.025%, and 0.01% atropine groups for myopia control after 2 years.
Since the ATOM 2 study, use of
Acknowledgments
The authors thank all the children and their parents for participating in this clinical trial; Mr. Yuzhou Zhang, Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, for support with statistical analysis; and Ms. Mandy P. H. Ng, Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, for overall coordination and logistic arrangements of the trial.
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Supplemental material available at www.aaojournal.org.
Presented at: the Association for Research in Vision and Ophthalmology, May 1, 2019, Vancouver, Canada Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Supported in part by the General Research Fund, Research Grants Council, Hong Kong, China (grant no.: 14111515 [J.C.Y.]); the Health and Medical Research Fund, Hong Kong, China (grant no.: 5160836 [L.J.C.]); the Direct Grants of the Chinese University of Hong Kong, Hong Kong, China (grant nos.: 4054193 [L.J.C.], 4054121 [J.C.Y.], and 4054199 [J.C.Y.]); the UBS Optimus Foundation (grant no.: 8984 [J.C.Y.]); the Centaline Myopia Fund (J.C.Y.); and the CUHK Jockey Club Children Eye Care Programme.
HUMAN SUBJECTS: Human subjects were included in this study. The human ethics committees at The Chinese University of Hong Kong approved the study. All research adhered to the tenets of the Declaration of Helsinki. All participants’ parents or guardians provided informed consent, and verbal assent was obtained from the study participants.
No animal subjects were included in this study.
Author Contributions:
Conception and design: Yam, Tang, Tham, Chen, Pang
Analysis and interpretation: Yam, Li, Zhang, Yip, Kam, Ko, Young, Tham, Chen, Pang
Data collection: Yam, Li, Tang
Obtained funding: Yam, Chen
Overall responsibility: Yam, Li, Zhang, Tang, Yip, Kam, Ko, Young, Tham, Chen, Pang