Combined 0.01% atropine with orthokeratology in childhood myopia control (AOK) study: A 2-year randomized clinical trial

Background: To investigate whether combining 0.01% atropine with orthokeratology (AOK) has a better effect in retarding axial elongation, compared with orthokeratology alone (OK) over two years. Methods: A total of 96 Chinese children aged six to < 11 years with myopia (1.00 – 4.00 D, inclusive) were randomized into either the AOK or OK group in a 1:1 ratio. Axial length (the primary outcome), and secondary outcomes (e.g. pupil size and choroidal thickness) were measured at 1-month and at 6-monthly intervals after commencement of treatment. Results: Both intention-to-treat and per-protocol analyses showed significantly slower axial elongation in the AOK group than OK group over two years (P = 0.008, P < 0.001, respectively). AOK subjects had statistically slower axial elongation (adjusted mean [standard error], 0.17 [0.03] mm vs 0.34 [0.03] mm, P < 0.001), larger increase in mesopic (0.70 [0.09] mm vs 0.31 [0.09] mm, P = 0.003) and photopic pupil size (0.78 [0.07] mm vs 0.23 [0.07] mm, P < 0.001), and greater thickening of the choroid (22.6 [3.5] µm vs −9.0 [3.5] µm, P < 0.001) than OK subjects over two years. Except for a higher incidence of photophobia in the AOK group (P = 0.006), there were no differences in the incidence of any other symptom or adverse events between the two groups. Slower axial elongation was associated with a larger increase in the photopic pupil size and a greater thickening in the choroid in the AOK group. Conclusions: Slower axial elongation following 2-year AOK treatment may result from increased pupil dilation and a thickening in the choroid observed in the AOK group.