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.
Our results showed that SMILE offered a less favourable astigmatic correction comparable to femtosecond-assisted LASIK in eyes with low to moderate myopic astigmatism. The alignment of treatment was more variable in SMILE, leading to a lower efficacy compared with LASIK by 3 months postoperatively.
Purpose: To compare the changes in higher order aberrations (HOA's) for photopic and mesopic pupil diameters in children undergoing orthokeratology treatment (OK) or combined 0.01% atropine with orthokeratology treatment (AOK), and their association with axial elongation. Methods: Children aged 6 to <11 years with 1.00-4.00 D of myopia were randomly assigned to each treatment group. Photopic and mesopic pupil diameters were quantified using automated pupillometry and HOA's were measured with a Hartmann-Shack aberrometer and Badal system to control for accommodation. HOA's were rescaled to photopic and mesopic pupil diameters and fitted with a 6 th order Zernike polynomial expansion. Axial length was measured using an optical biometer under cycloplegia. Results: Baseline and six-month data from 25 AOK and 28 OK participants were analysed. At the six-month visit, pupil diameter was larger in the AOK group under photopic conditions (3.70 AE 0.42 vs 3.12 AE 0.33 mm, p < 0.001), along with a range of HOA metrics [3 rd to 6 th order and higher order root mean square error values (HO RMS), all p ≤ 0.003] and individual Zernike terms (primary spherical aberration, and oblique quadrafoil, both p ≤ 0.03). Axial elongation was greater in the OK treatment group (0.05 AE 0.08 vs À0.01 AE 0.12 mm, p = 0.02). In the AOK group, axial elongation was correlated with the increase in photopic pupil diameter (r = À0.45, p = 0.02) and with several HOA metrics; however, these associations were not observed in the OK group. Conclusion: AOK treatment resulted in increased photopic pupil size and HOA's, and significantly less axial elongation over a six-month period compared to OK treatment alone. The improved myopia control observed with combination 0.01% atropine and orthokeratology may be a result of an enhanced optical effect due to a larger photopic pupil size.
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