Effect of low-dose atropine on young premyopic and low-myopic children: atropine treatment of myopia (ATOM3) - a randomised control trial.

Abstract

To evaluate the effectiveness of atropine 0.01% in young premyopic and low-myopic children. Children (5-9 years old) with premyopia (spherical equivalent refraction, SER+1.00 to -0.49D, n 156) or low myopia (SER -0.50 to -1.50D, n 52), with at least 1 parent with myopia <-3.00D, were randomised to receive placebo or atropine 0.01% eye-drops in a 1:1 ratio. Cycloplegic autorefraction and axial length were measured every 6 months over 2 years. Mean baseline SER was +0.5+/-0.04D in premyopia and -1.00±0.06D in the low-myopia eyes. Progression over 2 years in premyopic eyes was -0.96±0.10D vs -0.82±0.10D (p=0.328), or 0.72±0.03 mm vs 0.63±0.04 mm (p=0.161) in the placebo and atropine groups, respectively. Progression in eyes remaining emmetropic was -0.43±0.37D vs -0.29±0.37D (p=0.007) or 0.49±0.22 mm vs 0.41±0.38 mm (p=0.209) in the placebo versus atropine-treated eyes, respectively; while eyes which became myopic progressed by -1.78±0.82D vs -1.63±0.82D (p=0.121) or 1.08±0.34 mm vs 0.96±0.14 mm (p=0.010). Incident myopia at 2 years was 42.6% in placebo and 44.8% in atropine 0.01% treated eyes (p=0.896). In the low-myopia group, placebo versus atropine treated eyes progressed by -1.65±0.15D vs -1.23±0.15D (p=0.066) or 0.86±0.07 mm vs 0.68±0.05 mm (p=0.062) at 2 years. There was no difference in near acuity, glare (2.7%) or allergy (6.0%) between treatment groups. Although there were no significant differences in myopia progression between atropine and placebo treated eyes, there were trends towards less myopic shift in atropine-treated eyes in premyopic eyes which remained emmetropic and in eyes with low myopia.