This randomized, placebo-controlled, double-blind trial was conducted in China between July 2017 and June 2022, at 474 children non-myopic aged 4 to 9 years old (spherical equivalent under cyclopegic eye drops between + 1.00 D and 0.00 D; astigmatism < – 1.00 D; anisometropia < 2.00 D; at least one relative with myopia of at least 3.00 D). The average age of the participants was 6.8 years; there were 50% girls. The following were excluded: children with ocular pathologies (amblyopia, congenital diseases of the retina, strabismus, cataracts, etc.); those who have previously used atropine or pirenzepine and those using orthokeratology or other optical methods for the management of myopia; children allergic to atropine or having systemic diseases or developmental abnormalities. Finally, 74.5% of the children completed the trial, but this high dropout rate – similar regardless of the arm of the study – had been anticipated in the calculations.
Participants were randomly assigned to one of the following three arms: atropine 0,05 % (N = 160), atropine 0,01 % (N=159) or placebo in the form of sodium chloride (N=155); eye drops were applied once a day, in the evening, to both eyes, for 2 years. The primary endpoints were: the cumulative incidence of myopia over 2 years (at least −0.50 D) and the percentage of participants with rapid progression, of 1.00 D, over this same period.
Results: compared to the placebo group, the group receiving atropine 0.05% had a significantly lower cumulative incidence of myopia at 2 years (difference of 24.6% : incidence of 28.4% versus 53.0% for the placebo) as well as a percentage of participants with significantly lower rapid myopia progression at 2 years (25.0% versus 53.9%, a difference of 28.9%). The differences between the atropine 0.05% and 0.01% groups were also significant: 17.5% and 20.1% for each endpoint. On the other hand, no significant difference was detected between the atropine 0.01% and placebo groups.
Daily instillation of 0.05% atropine eye drops has therefore shown a beneficial effect in reducing the incidence of myopia. In addition, the percentage of participants reporting adverse effects, primarily photophobiawas weak and without notable difference between the three groups (12.9% in the atropine 0.05% group; 18.9% in the atropine 0.01% group and 12.2% in the placebo).
