One‐year results of 0.01% atropine with orthokeratology (AOK) study: a randomised clinical trial

Abstract

Purpose To report the 1‐year results of an investigation into whether there is an additive effect between 0.01% atropine and orthokeratology (ortho‐k), in a single‐masked, two‐arm, randomised controlled trial: Combined Atropine with Orthokeratology (AOK) for myopia control study (ClinicalTrials.gov number: NCT02955927). Methods Chinese children aged between 6 and 11 years with 1.00–4.00 D of myopia, astigmatism <2.50 D, and no more than 1.00 D anisometropia, were randomly assigned either to an AOK group or ortho‐k only (OK) group at a 1:1 ratio. Subjects in the AOK group instilled one drop of 0.01% atropine into each eye, 10 min before nightly wear of ortho‐k lenses. The primary outcome, axial elongation, was examined at 6‐monthly intervals, along with secondary outcomes including best‐corrected visual acuity (BCVA), manifest refraction, accommodation, pupil size, and corneal topography. Results 29 AOK and 30 OK subjects completed the 1‐year visit. The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p = 0.03). A significant between‐group difference in axial elongation was observed over the first 6‐month period only (p < 0.001), but not over the second period (p = 0.818). At the 1‐year visit, increases in mean (S.D.) mesopic and photopic pupil sizes in the AOK group were 0.64 (0.48) mm and 0.36 (0.34) mm, respectively, which were significantly higher than 0.10 (0.50) mm and 0.02 (0.28) mm in the OK group (p < 0.001). At the 6‐month visit, a significant moderate negative correlation was found between axial elongation and the increase in photopic pupil size (r = −0.42, p = 0.02) in the AOK group. Conclusions There is an additive effect between 0.01% atropine and ortho‐k over one year, with mean axial elongation in the AOK group 0.09 mm slower than that in the OK group. It appears that the additive effect was only during the first six months; a second‐year investigation is warranted to determine whether the effect is sustained over time.

Update and guidance on management of myopia. European Society of Ophthalmology in cooperation with International Myopia Institute

“…328 A recent study showed an additive effect between 0.01% atropine and ortho-K over 1 year, with mean axial elongation in the atropin with orthokeratology group 0.09 mm/year slower than that in the ortho-K group. 329 A review reported that all included studies improved myopia control by the synergistic effect of ortho-K with low-dose atropine, compared with orthokeratology treatment alone. 330 Another pharmacological and optical combination therapy is the use of multifocal spectacles with 0.5% atropine.…”

The Effect of Atropine Alone or Combined with Orthokeratology for Children with Myopia: A Meta-Analysis

“…It may be related to that the follow-up time of this study is only one month, while other studies are more than one year. Subgroup 2 (midium myopia"-3~ -6D") showed that the heterogeneity decreased from 54% to 0% after excluding Tang 2020, [29] but the results remained unchanged. (Table 3 ).…”

“…There were 6 studies with baseline SER ranging from -1 to -3D ,146 patients in AOK group and 149 patients in ortho-k group. [24][27][29] [31]1 The combined results showed that the WMD in the low myopia subgroup was -0.10 mm (95% CI, -0.14, -0.05), which represented that the mean axial elongation of AOK was 0.10 mm shorter than that of ortho-kwithin baseline diopter -3D.There were 3 studies [24][27] [29] with baseline SER ranging from -3 to -6D,62 patients in AOK group and 62 patients in ortho-k group. The combined results showed that the WMD of the midium myopia subgroup was -0.04mm (95% CI, -0.11, 0.03).…”

“…(Table 3 ). It suggested that Tang2020 [29] took the axial length at 1 months after wearing OK as the baseline Kinoshita2018 and 2020 [24][27] took the axial length at 3 months after wearing OK lensas the baseline. The central corneal thickness tends to stabilize after the rst 1-2 months of OK therapy, [37][38] which may affect the experimental results.…”

The effect of 0.01% atropine on ocular axial elongation for myopia children: a meta-analysis

“…We reviewed the titles and abstracts of all articles and excluded 12 articles; full texts and data integrity were also reviewed and 15 were further excluded. Finally, studies that met all inclusion criteria were included in this meta-analysis [13][14][15][17][18][19][20][21][22]. Figure1 showed the selection process of eligible articles.…”