The efficacy and safety of combined 0.01% atropine and orthokeratology for childhood myopia control: a 2-year randomized clinical trial

Purpose To explore the efficacy and safety of combined low-concentration atropine and orthokeratology lenses (AOK) for slowing the progression of myopia. Methods In this randomized, placebo-controlled, double-blinded, multicenter clinical trial. Children ( n = 96) aged 8–12 years with myopia between −1.00D and −4.00D and astigmatism of no more than 1.5D in either eye were randomly assigned to the AOK or orthokeratology (OK) group. The primary outcome, axial elongation, was examined at baseline and visited at 6, 12, 18 and 24 months, along with secondary outcomes, including tear meniscus height (TMH), non-invasive break-up time (NIBUT), visual acuity and dynamic changes of pupillary light reflex. Results Over the 24 months, the axial elongation was significantly slower in the AOK group than in the OK group (0.33 ± 0.17 mm vs. 0.43 ± 0.16 mm, respectively; p = 0.004). In the subgroup analysis, there were significant differences in the change of axial length in the subgroup of subjects with an initial spherical equivalent refraction (SER) of −1.00 to −3.00D or aged 8–10 years ( p = 0.017, 0.021, respectively). At the 24-month visit, the changes in TMH, NIBUT, visual acuity and pupil size in the AOK group were insignificantly different from those in the OK group (p>0.05, respectively). The latency of the pupillary light reflex was significantly longer in the AOK group than in the OK group ( p = 0.029). Conclusion The combination of 0.01% atropine and orthokeratology produced a combined effect in slowing axial elongation over 2 years, with good tolerability and minimal ocular surface impact. Clinical Trial Registration https://www.chictr.org.cn/showprojEN.html?proj=29216 , identifier ChiCTR1800018419.