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Published on: September 27, 2024
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Atropine Ophthalmic Solution to Reduce Myopia Progression in Pediatric Subjects: The Randomized, Double-Blind
Audrey Chia1, Cheryl Ngo2, Nozhat Choudry3
1Singapore National Eye Centre, Singapore, Singapore.
Summary
Low-dose atropine eye drops at 0.005% and 0.01% effectively slow myopia progression in children. The lowest dose (0.0025%) showed no effect, but all atropine formulations were safe and well-tolerated.
Area of Science:
- Ophthalmology
- Pediatric Medicine
- Pharmacology
Background:
- Myopia, or nearsightedness, is a growing public health concern in children.
- Effective interventions are needed to slow myopia progression and prevent associated eye health complications.
Purpose of the Study:
- To evaluate the dose-response relationship of low-dose atropine in managing pediatric myopia.
- To assess the safety and efficacy of different atropine concentrations (0.0025%, 0.005%, 0.01%) compared to placebo.
Main Methods:
- A phase II, randomized, double-masked, placebo-controlled trial involving 99 children (aged 6-11) with mild-to-moderate myopia.
- Participants received one drop of atropine or placebo in each eye nightly for 12 months.
- Primary outcome was change in spherical equivalent (SE); secondary outcomes included axial length (AL) and visual acuity.
Main Results:
- Atropine 0.005% and 0.01% significantly reduced myopia progression (SE changes of -0.33 D and -0.39 D, respectively) compared to placebo (-0.55 D).
- Significant differences in axial length elongation were observed with 0.005% (-0.09 mm) and 0.01% (-0.10 mm) atropine versus placebo.
- No significant changes in near visual acuity were noted; common side effects included mild pruritus and blurred vision, with minimal impact on pupil size or accommodation.
Conclusions:
- Low-dose atropine at 0.005% and 0.01% demonstrates efficacy in slowing myopia progression in children.
- The 0.0025% atropine dose was not effective in this study.
- All tested atropine concentrations were found to be safe and well-tolerated by pediatric participants.
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