Singapore National Eye Center, Singapore; Singapore Eye Research Institute, Singapore.
Duke-National University of Singapore Graduate Medical School, Singapore; Singapore Clinical Research Institute, Singapore.
Am J Ophthalmol. 2014 Feb;157(2):451-457.e1. doi: 10.1016/j.ajo.2013.09.020. Epub 2013 Dec 4.
To study the change in spherical equivalent and other ocular parameters 1 year after stopping the administration of atropine.
Prospective randomized double-masked clinical trial.
We assigned 400 myopic children, 6 to 12 years of age, to receive atropine 0.5%, 0.1% or 0.01% for 24 months, after which medication was stopped. Parents and children gave informed consent to participate in the research. Children were reviewed at 26, 32 and 36 months, and changes in cycloplegic spherical equivalent (SE), axial length (AL), visual acuity, pupil size, and accommodation were assessed.
Of the children, 356 (89%) entered into the washout phase. At entry, there was no significant difference in age, gender, SE, or AL among the children in the various atropine groups. Over the following 12 months, myopic progression was greater in the 0.5% eyes (-0.87 ± 0.52 D), compared to the 0.1% (-0.68 ± 0.45 D) and 0.01% eyes (-0.28 ± 0.33 D, P < 0.001). AL growth was also greater in the 0.5% (0.35 ± 0.20 mm) and 0.1% (0.33 ± 0.18 mm) eyes, compared to the 0.01% eyes (0.19 ± 0.13 mm, P < 0.001). Pupil size and near visual acuity returned to pre-atropine levels in all groups, but accommodation at 36 months was less in the 0.5% eyes (13.24 ± 2.72 D) compared to the 0.1% (14.45 ± 2.61 D) and 0.01% eyes (14.04 ± 2.90 D, P < 0.001). The overall increase in SE over the entire 36 months in the 0.5%, 0.1% and 0.01% groups was -1.15 ± 0.81 D, -1.04 ± 0.83 D and -0.72 ± 0.72 D, respectively (P < 0.001).
There was a myopic rebound after atropine was stopped, and it was greater in eyes that had received 0.5% and 0.1% atropine. The 0.01% atropine effect, however, was more modulated and sustained.
研究停用阿托品 1 年后的等效球镜和其他眼部参数的变化。
前瞻性随机双盲临床试验。
我们将 400 名 6 至 12 岁的近视儿童分为 3 组,分别使用 0.5%、0.1%或 0.01%阿托品滴眼 24 个月,然后停药。家长和孩子均同意参与研究。在 26、32 和 36 个月时进行随访,评估散瞳等效球镜(SE)、眼轴(AL)、视力、瞳孔大小和调节的变化。
356 名(89%)儿童进入洗脱期。入组时,不同浓度阿托品组儿童的年龄、性别、SE 或 AL 无显著差异。在随后的 12 个月中,0.5%阿托品组(-0.87 ± 0.52 D)的近视进展大于 0.1%(-0.68 ± 0.45 D)和 0.01%(-0.28 ± 0.33 D,P < 0.001)组。0.5%(0.35 ± 0.20 mm)和 0.1%(0.33 ± 0.18 mm)组的 AL 增长也大于 0.01%组(0.19 ± 0.13 mm,P < 0.001)。所有组的瞳孔大小和近视力均恢复到阿托品治疗前水平,但 0.5%组 36 个月时的调节力(13.24 ± 2.72 D)低于 0.1%(14.45 ± 2.61 D)和 0.01%(14.04 ± 2.90 D,P < 0.001)组。0.5%、0.1%和 0.01%组在整个 36 个月的 SE 总增加量分别为-1.15 ± 0.81 D、-1.04 ± 0.83 D 和-0.72 ± 0.72 D(P < 0.001)。
阿托品停药后出现近视反弹,0.5%和 0.1%阿托品组的反弹更明显。然而,0.01%阿托品的效果更为缓和且持久。