The Efficacy and Safety of Combined 0.01% Atropine and Orthokeratology for Childhood Myopia Control: A 2-Year Randomized Clinical Trial

AI Generated Summary*

Ninety-six Chinese children aged 8 to 12 with -1.00 to -4.00 D myopia were randomized in a double-masked, placebo-controlled, multicenter trial to orthokeratology plus 0.01% atropine or placebo drops; the primary endpoint was 24-month axial elongation. Elongation was 0.33 mm with the combination versus 0.43 mm with orthokeratology alone (p=0.004), a 0.10 mm gap significant only from 18 months. Exploratory subgroup differences were significant only for baseline refraction of -1.00 to -3.00 D or age under 10. Changes in tear meniscus height, non-invasive break-up time, visual acuity and pupil size did not differ significantly between groups, though pupillary light reflex latency was longer with atropine (p=0.029). Adverse events were mild, without infectious keratitis; no atropine-only arm was included.

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