Abstract
Background. To explore the effect of atropine 0.01% on accommodation functions and pupil size for safely and effectively controlling myopia in Chinese children.Methods. This was a single-center randomized clinical trial. 63 participants with myopia of at least −0.50 D and astigmatism of ≤−2.50 D were enrolled and randomized to receive atropine 0.01% once nightly with regular single-vision lenses or to wear regular single-vision lenses, in an allocation ratio of 3 : 2. Primary outcomes included changes of accommodation functions, pupil diameter, distant and near best-corrected visual acuity (BCVA), near stereoacuity, and intraocular pressure (IOP). Secondary outcome was myopic progression at 6 months.Results. 61 participants completed the follow-up. Compared with the control group, the atropine-treated children showed a statistically significant increase in pupil diameter after 6 months (0.7 ± 0.7 vs. 0.1 ± 0.5 mm,P=0.01). Despite the enlarged pupil, routine vision-related activities were not affected. The mean changes in accommodative functions, BCVA, near stereoacuity, and IOP, did not differ significantly between the groups. At 6 months, participants in the control group showed greater myopia progression than those in the atropine group (spherical equivalent: −0.60 ± 0.43 vs.−0.30 ± 0.42 D,P<0.001; axial length: 0.35 ± 0.20 vs. 0.24 ± 0.16 mm,P=0.001).Conclusions. Atropine 0.01% eye drops significantly increased pupil diameter less than one mm, but it did not affect accommodative functions, BCVA, near stereoacuity, and IOP. Combined with its reducing myopia progression, atropine 0.01% can be used as a safe and effective treatment for myopia in Chinese children.
Highlights
To explore the effect of atropine 0.01% on accommodation functions and pupil size for safely and effectively controlling myopia in Chinese children
Between July 2017 and July 2018, a total of 70 participants were assessed for their eligibility, and 63 participants were recruited to the study: 38 participants were allocated to the atropine group and 25 to the control group (Figure 1). e baseline characteristics
A statistically significant increase in the pupil diameter was observed in the atropine group (P < 0.001), with an average diameter of 6.2 mm at baseline increasing to 7.0 mm at 6-month visit (Table 3). e pupil diameter remained stable in the control group over time
Summary
To explore the effect of atropine 0.01% on accommodation functions and pupil size for safely and effectively controlling myopia in Chinese children. E primary purpose of the present randomized clinical trial was to investigate the effect of atropine 0.01% on amplitude of accommodation, accommodative facility (AF), pupil size, distant and near BCVA, near stereoacuity, intraocular pressure (IOP), and difficulties affecting routine vision-related activities in Chinese children, with myopia progression being the secondary outcome measure. Children aged 6 to 14 years Refractive error of spherical equivalent between −0.50 D and −6.00 D†‡ Astigmatism of −2.50 D or less† Best-corrected visual acuity of logMAR 0.1 or better in both eyes No history of other ocular diseases (i.e., amblyopia, strabismus, cataract, glaucoma, and congenital retinal diseases) In good general health with no history of significant cardiac, respiratory, or endocrine diseases No allergy to atropine, tropicamide, and cyclopentolate No current or previous use of atropine or pirenzepine, contact lenses, or other forms of treatment that might affect myopia progression Willing to comply with the allocated treatment and follow-up schedule logMAR logarithm of the minimum angle of resolution. All statistical tests were performed with STATA 13.0 (College Station, TX, USA)
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