局部阿托品滴眼液用于儿童近视控制的临床试验结果显示,短期研究结果不一致,报告的长期安全性或其他结果很少。
■报告局部阿托品用于儿童近视控制的长期安全性和结果。
■这个前景,阿托品治疗近视(ATOM)1和ATOM2随机临床试验的双盲观察研究在2个单中心进行,纳入了2021年至2022年ATOM1研究(阿托品1%vs安慰剂;1999年至2003年)和ATOM2研究(阿托品0.01%vs0.1%vs0.5%;2006年至2012年)的成人.
■睫状肌麻痹球当量(SE)随轴向长度(AL)的变化;眼部并发症的发生率。
■在每个原始队列中的原始400名参与者中,研究小组评估了400名ATOM1成人参与者中的71名(原始队列的17.8%;研究年龄,平均[SD]30.5[1.2]年;40.6%女性)和400名ATOM2成人参与者中的158名(原始队列的39.5%;研究年龄,意思是[SD],24.5[1.5]年;42.9%女性)基线特征(SE和AL)代表原始队列。在这项研究中,评估ATOM1参与者,平均(SD)SE和AL为-5.20(2.46)屈光度(D),25.87(1.23)mm和-6.00(1.63)D,1%阿托品治疗组和安慰剂组的25.90(1.21)mm,分别(SE的差异,0.80D;95%CI,-0.25至1.85D;P=0.13;AL差异,-0.03毫米;95%CI,-0.65至0.58毫米;P=.92)。在ATOM2参与者中,平均值(SD)SE和AL为-6.40(2.21)D;26.25(1.34)mm;-6.81(1.92)D,26.28(0.99)毫米;和-7.19(2.87)D,26.31(1.31)mm中的0.01%,0.1%,和0.5%阿托品组,分别。白内障/晶状体混浊的20年发病率没有差异,近视性黄斑变性,或比较1%阿托品治疗组与安慰剂组的乳头旁萎缩(β/γ区)。
■在大约四分之一的原始参与者中,在儿童期使用0.01%~1.0%的短期局部用阿托品滴眼液,持续2~4年,与治疗后10~20年的最终屈光不正差异无关.与安慰剂组相比,1%阿托品治疗组的治疗或近视相关眼部并发症的发生率没有增加。这些发现可能会影响未来临床试验的设计,因为需要进一步的研究来调查阿托品用于儿童近视控制的持续时间和浓度。
UNASSIGNED: Clinical
trial results of topical atropine eye drops for childhood myopia control have shown inconsistent outcomes across short-term studies, with little long-term safety or other outcomes reported.
UNASSIGNED: To report the long-term safety and outcomes of topical atropine for childhood myopia control.
UNASSIGNED: This prospective, double-masked observational study of the Atropine for the Treatment of Myopia (ATOM) 1 and ATOM2 randomized clinical trials took place at 2 single centers and included adults reviewed in 2021 through 2022 from the ATOM1 study (atropine 1% vs placebo; 1999 through 2003) and the ATOM2
study (atropine 0.01% vs 0.1% vs 0.5%; 2006 through 2012).
UNASSIGNED: Change in cycloplegic spherical equivalent (SE) with axial length (AL); incidence of ocular complications.
UNASSIGNED: Among the original 400 participants in each original cohort, the study team evaluated 71 of 400 ATOM1 adult participants (17.8% of original cohort;
study age, mean [SD] 30.5 [1.2] years; 40.6% female) and 158 of 400 ATOM2 adult participants (39.5% of original cohort;
study age, mean [SD], 24.5 [1.5] years; 42.9% female) whose baseline characteristics (SE and AL) were representative of the original cohort. In this
study, evaluating ATOM1 participants, the mean (SD) SE and AL were -5.20 (2.46) diopters (D), 25.87 (1.23) mm and -6.00 (1.63) D, 25.90 (1.21) mm in the 1% atropine-treated and placebo groups, respectively (difference of SE, 0.80 D; 95% CI, -0.25 to 1.85 D; P = .13; difference of AL, -0.03 mm; 95% CI, -0.65 to 0.58 mm; P = .92). In ATOM2 participants, the mean (SD) SE and AL was -6.40 (2.21) D; 26.25 (1.34) mm; -6.81 (1.92) D, 26.28 (0.99) mm; and -7.19 (2.87) D, 26.31 (1.31) mm in the 0.01%, 0.1%, and 0.5% atropine groups, respectively. There was no difference in the 20-year incidence of cataract/lens opacities, myopic macular degeneration, or parapapillary atrophy (β/γ zone) comparing the 1% atropine-treated group vs the placebo group.
UNASSIGNED: Among approximately one-quarter of the original participants, use of short-term topical atropine eye drops ranging from 0.01% to 1.0% for a duration of 2 to 4 years during childhood was not associated with differences in final refractive errors 10 to 20 years after treatment. There was no increased incidence of treatment or myopia-related ocular complications in the 1% atropine-treated group vs the placebo group. These findings may affect the design of future clinical trials, as further studies are required to investigate the duration and concentration of atropine for childhood myopia control.