Atropine, 0.01%, eye drops can slow the progression of myopia and axial length in children with low and moderate myopia, compared with placebo treatment, according to a newly published study in JAMA Ophthalmology.
Investigators say this is the first study to evaluate the efficacy and safety of low concentrations of atropine, 0.01%, in a randomized, double-masked placebo-controlled trial in Mainland China.
A total of 220 children (53% male, 46.8% female) aged 6 to 12 years with myopia of −1.00 D to −6.00 D in both eyes were enrolled between April and July 2018 at Beijing Tongren Hospital in Beijing, China. Cycloplegic refraction and axial length were measured at baseline, 6 months and 12 months.
On randomizing and masking in this study, the authors write, “Every eligible 4 children were randomly allocated into the intervention group or control group according to the priority order the children visited the hospital for treatment. The atropine, 0.01%, and placebo eye drops were packaged in identical bottles, and thus, investigators and participants were not able to identify the contents. The data analysts were also blinded to minimize observational bias.”
At baseline, no relevant differences were identified in demographics, initial SE, initial AL, IOP, age at myopia onset, parental myopia, time outdoors, and nearwork between 2 groups—the atropine, 0.01%, and the placebo-control.
Some of the 220 participants did not continue after 6 months, resulting in 76 children (69%) and 83 children (75%) allocated into the atropine, 0.01%, and placebo groups, respectively, who returned for the 1-year primary outcome assessment visit.
At the 1-year follow-up, the mean (SD) myopia progression values for the atropine, 0.01%, group and the placebo group were −0.49 (0.42) D and −0.76 (0.50) D (mean difference, 0.26 D; 95% CI, 0.12-0.41 D; P < .001), with relative reduction of 34.2% in myopia progression. Nonprogressors had a mean myopia progression of −0.14 (0.23) D compared with −0.83 (0.24) D for progressors (P < .001). The mean 1-year change in spherical equivalent was −0.49 D (95% CI, −0.59 to −0.39 D) for the atropine, 0.01%, group and −0.77 D (95% CI, −0.86 to −0.67 D) for the placebo group (analysis of covariance, mean difference, 0.28 D; 95% CI, 0.14-0.42 D; P <.001) after adjusting for age at baseline. The mean (SD) axial elongation values for the atropine, 0.01%, group and placebo group were 0.32 (0.19) mm and 0.41 (0.19) mm (mean difference, 0.09 mm; 95% CI, 0.03-0.15 mm; P =.004), with a reduction of 22.0% in axial elongation.
Nonprogressors had a mean (SD) axial elongation of −0.18 (0.14) mm, compared with −0.45 (0.14) mm for progressors (P <.001). The mean 1-year change in axial length was 0.31 mm (95% CI, 0.27-0.35 mm) for the atropine, 0.01%, group and 0.41 mm (95% CI, 0.37-0.45 mm) for the placebo group (analysis of covariance, mean difference, 0.10 mm; 95% CI, 0.05-0.16 mm; P <.001) after adjusting for age at baseline.
The authors write, “At 6 months, 81.6% of children progressed by less than 0.5 D in the atropine, 0.01%, group compared with 61.5% in the placebo group, whereas no children progressed by 1.00 D or greater, compared with 3.6% in the placebo group. At 12 months, 48.7% of children progressed by less than 0.50 D and 13.2% at least 1.00 D in the atropine, 0.01%, group, compared with 30.1% and 34.9%, respectively, in the placebo group.”
Limitations of this study include potential bias introduced by a loss to follow-up rate of approximately 70% in each group, and follow-up only being 1 year.
Myopia is now a public health problem of critical concern among children and adults, especially in East and Southeast Asia. It’s the most common cause of avoidable visual impairment and blindness. Also, high or pathologic myopia is associated with increased risk of irreversible blinding conditions, including myopic retinopathy, retinal detachment, choroidal neovascularization and glaucoma.
Wei S, Li S, An W, et al. Safety and efficacy of low-dose atropine eyedrops for the treatment of myopia progression in chinese children a randomized clinical trial. JAMA Ophthalmol. Published online October 1, 2020. doi: 10.1001/jamaophthalmol.2020.3820