Abstract
Purpose :
Low dose atropine is a promising therapy for myopia control, but its evidence has not been substantiated, and the optimal dosage has not been identified. We conducted a double-blinded, randomized placebo-controlled trial to establish the efficacy and safety of various low dose atropine (0.01%, 0.025% and 0.05%), and to identify the best optimal dosage for myopia control.
Methods :
Children aged 4-12 years with myopia at least -1 Diopter (D), and astigmatism of -2.5 D or less, were randomized in 1:1:1:1 ratio to 0.05% atropine, 0.025% atropine, 0.01% atropine, and placebo drops, to be administered once nightly to both eyes for one year. Cycloplegic refraction, best corrected visual acuity, accommodation, pupil size, and axial length were measured at baseline, 2 weeks, and then every 4 months for one years. Visual Functioning Questionnaire-25 (VFQ-25) was administered at the one-year visit. Generalized estimating equation with robust standard errors was used to test the difference of the outcome measures among groups. Multiple comparisons were performed with Bonferroni adjustment.
Results :
A total of 442 children were recruited. The one-year results were showed in Table 1. The mean myopia progression at one year was 0.26 D, 0.47 D, 0.58 D, and 0.82 D in the atropine 0.05%, 0.025%, 0.01%, and placebo groups, respectively. Myopia progression in all low dose atropine groups was significantly lower than that of placebo group in a dose-related pattern (p<.01). The mean increase in axial length was 0.21mm, 0.31mm, 0.33mm, and 0.43mm in the 0.05%, 0.025%, 0.01%, and placebo groups, respectively. Reduction in accommodation amplitude was -1.9 D, -1.6 D, -0.28 D, and -0.28 D in 0.05%, 0.025%, 0.01% and placebo, respectively. The change in pupil size under both photopic and scotopic conditions followed dose response (p<.01). The effect of atropine on accommodation amplitude and pupil size in all groups was small and clinically insignificant. VFQ-25, and change in near VA was similar among all groups.
Conclusions :
Low dose atropine (0.05%, 0.025%, 0.01%) once nightly was effective in retarding the myopia progression, when compared with placebo group. Atropine 0.05% have a better efficacy and yet maintain a safe treatment profile than other groups.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.