School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.
Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.
Ophthalmic Physiol Opt. 2020 Sep;40(5):557-566. doi: 10.1111/opo.12722. Epub 2020 Aug 10.
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).
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.
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.
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.
报告一项关于 0.01%阿托品与角膜塑形术（ortho-k）联合应用是否具有附加效应的研究结果，该研究为单盲、双臂、随机对照试验：近视控制研究中的联合阿托品与角膜塑形术（AOK）（ClinicalTrials.gov 编号：NCT02955927）。
6-11 岁的中国儿童，近视 1.00-4.00 D，散光<2.50 D，双眼屈光参差不超过 1.00 D，按 1:1 的比例随机分配至 AOK 组或仅行角膜塑形术（OK）组。AOK 组在夜间佩戴角膜塑形镜前 10 分钟，每只眼滴一滴 0.01%阿托品。每隔 6 个月检查主要结局指标（眼轴伸长），同时检查次要结局指标，包括最佳矫正视力（BCVA）、显性折射、调节、瞳孔大小和角膜地形图。
29 名 AOK 组和 30 名 OK 组受试者完成了 1 年的随访。AOK 组的眼轴伸长率明显低于 OK 组（平均（标准差），0.07（0.16）mm 比 0.16（0.15）mm，p=0.03）。仅在前 6 个月观察到组间差异有统计学意义（p<0.001），而在后 6 个月差异无统计学意义（p=0.818）。在 1 年的随访中，AOK 组中中、暗光瞳孔大小的平均（标准差）分别增加了 0.64（0.48）mm 和 0.36（0.34）mm，明显高于 OK 组的 0.10（0.50）mm 和 0.02（0.28）mm（p<0.001）。在 6 个月的随访中，AOK 组眼轴伸长与明视瞳孔大小增加之间存在显著的中度负相关（r=-0.42，p=0.02）。
在 1 年的时间里，0.01%阿托品与角膜塑形术联合应用具有附加效应，AOK 组的平均眼轴伸长比 OK 组慢 0.09mm。似乎这种附加效应只在最初的 6 个月内起作用；需要进行第二年的研究，以确定这种效应是否随着时间的推移而持续。
