Atropine 0.01% eyedrops can slow myopia progression and axial elongation in children: JAMA

Several randomized clinical trials have been investigated to halt or slow myopic progression including undercorrection, progressive addition lenses, contact lenses, pirenzepine gel, and increased outdoor activity. At present, topical atropine has been demonstrated to have the strongest clinical effect on slowing the progression of myopia.

Wei et al aimed 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 aged 6 to 12 years with myopia of −1.00 D to −6.00 D in both eyes were enrolled between April 2018 and July 2018 at Beijing Tongren Hospital, Beijing, China. Cycloplegic refraction and axial length were measured at baseline, 6 months, and 12 months. Adverse events were also recorded. Patients were randomly assigned in a 1:1 ratio to atropine, 0.01%, or placebo groups to be administered once nightly to both eyes for 1 year.

Main outcomes and measures included mean changes and percentage differences in myopia progression and axial elongation (AL) between atropine, 0.01%, or placebo groups. Myopia progression defined as the mean change in cycloplegic SE over 1 year. Three levels of myopia progression were defined as less than 0.50 D (mild), between 0.50 D and less than 1.00 D (moderate), and 1.00 D or greater (severe). If the myopia progression was less than 0.50 D over 1 year, children were considered as nonprogressors and otherwise as progressors. The secondary outcomes included AL change over 1 year. Adverse events were recorded based on what patients and parents were asked and examined during the treatment.

Between April 2018 and July 2019, a total of 268 children were initially assessed in this study; 21 of them did not meet the inclusion criteria, 12 of them met the exclusion criteria, and 15 of them declined to participate in this study, leaving 220 children were enrolled in the study with equal randomization to the atropine, 0.01%, and the placebo-control groups.

RESULTS:

• 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 (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 for the atropine, 0.01%, group and −0.77 D for the placebo group (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 (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 for the atropine, 0.01%, group and 0.41 mm for the placebo group (P < .001) after adjusting for age at baseline.

• 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. Overall, atropine, 0.01%, was generally well tolerated and no serious adverse effects were observed.

• In this study, the researchers found that a once-nightly dose of atropine, 0.01%, eyedrops resulted in reduction of myopia progression by a mean (SD) of 0.26 (0.07) D (34.2% reduction) and axial elongation by 0.09 (0.03) mm (22.0% reduction) compared with placebo treatment.

This study discovered that atropine, 0.01%, can slow the progression of myopia and axial length in children with low and moderate myopia, compared with placebo treatment. A once nightly dose of atropine, 0.01%, eyedrops was well tolerated without serious adverse events.

While the clinical relevance of the results cannot be determined from this trial, these 1-year results, limited by approximately 70% follow-up, suggest that atropine, 0.01%, eyedrops can slow myopia progression and axial elongation in children and warrant future studies to determine longer-term results and potential effects on slowing sight-threatening pathologic changes later in life.

Source: Wei et al; JAMA Ophthalmol.

doi:10.1001/jamaophthalmol.2020.3820