《低浓度阿托品治疗近视进展的两年临床研究（LAMP）：第二阶段报告》。
Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report.
机构信息
Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Hong Kong Eye Hospital, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.
Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.
出版信息
Ophthalmology. 2020 Jul;127(7):910-919. doi: 10.1016/j.ophtha.2019.12.011. Epub 2019 Dec 21.
PURPOSE
To evaluate the efficacy and safety of 0.05%, 0.025%, and 0.01% atropine eye drops over 2 years to determine which is the optimal concentration for longer-term myopia control.
DESIGN
Randomized, double-masked trial extended from the Low-Concentration Atropine for Myopia Progression (LAMP) Study.
PARTICIPANTS
Three hundred eighty-three of 438 children (87%) aged 4 to 12 years with myopia of at least -1.0 diopter (D) originally randomized to receive atropine 0.05%, 0.025%, 0.01%, or placebo once daily in both eyes in the LAMP phase 1 study were continued in this extended trial (phase 2).
METHODS
Children in the placebo group (phase 1) were switched to receive 0.05% atropine from the beginning of the second-year follow-up, whereas those in the 0.05%, 0.025%, and 0.01% atropine groups continued with the same regimen. Cycloplegic refraction, axial length (AL), accommodation amplitude, photopic and mesopic pupil diameter, and best-corrected visual acuity were measured at 4-month intervals.
MAIN OUTCOME MEASURES
Changes in spherical equivalent (SE) and AL and their differences between groups.
RESULTS
Over the 2-year period, the mean SE progression was 0.55±0.86 D, 0.85±0.73 D, and 1.12±0.85 D in the 0.05%, 0.025%, and 0.01% atropine groups, respectively (P = 0.015, P < 0.001, and P = 0.02, respectively, for pairwise comparisons), with mean AL changes over 2 years of 0.39±0.35 mm, 0.50±0.33 mm, and 0.59±0.38 mm (P = 0.04, P < 0.001, and P = 0.10, respectively). Compared with the first year, the second-year efficacy of 0.05% and 0.025% atropine remained similar (P >0.1), but improved mildly in the 0.01% atropine group (P = 0.04). For the phase 1 placebo group, the myopia progression was reduced significantly after switching to 0.05% atropine (SE change, 0.18 D in second year vs. 0.82 D in first year [P < 0.001]; AL elongated 0.15 mm in second year vs. 0.43 mm in first year [P < 0.001]). Accommodation loss and change in pupil size in all concentrations remained similar to the first-year results and were well tolerated. Visual acuity and vision-related quality of life remained unaffected.
CONCLUSIONS
Over 2 years, the efficacy of 0.05% atropine observed was double that observed with 0.01% atropine, and it remained the optimal concentration among the studied atropine concentrations in slowing myopia progression.
目的
评估 0.05%、0.025%和 0.01%阿托品滴眼液在 2 年内的疗效和安全性，以确定哪种浓度最适合长期控制近视。
设计
在低浓度阿托品治疗近视进展（LAMP）研究的基础上进行的随机、双盲试验扩展。
参与者
383 名 4 至 12 岁的儿童（87%）最初随机接受每日一次的 0.05%、0.025%、0.01%阿托品或安慰剂治疗，共有 438 名儿童患有近视，屈光度至少为-1.0 （D），他们继续参与该扩展试验（第 2 阶段）。
方法
第 1 阶段安慰剂组（第 1 阶段）从第二年随访开始改为接受 0.05%阿托品，而 0.05%、0.025%和 0.01%阿托品组继续采用相同方案。每 4 个月测量一次睫状肌麻痹验光、眼轴（AL）、调节幅度、明视和中视瞳孔直径以及最佳矫正视力。
主要观察指标
等效球镜（SE）和 AL 的变化及其组间差异。
结果
在 2 年期间，0.05%、0.025%和 0.01%阿托品组的 SE 进展平均值分别为 0.55±0.86 D、0.85±0.73 D 和 1.12±0.85 D（P=0.015、P<0.001 和 P=0.02，分别为两两比较），2 年内 AL 变化的平均值分别为 0.39±0.35 mm、0.50±0.33 mm 和 0.59±0.38 mm（P=0.04、P<0.001 和 P=0.10，分别为两两比较）。与第一年相比，0.05%和 0.025%阿托品的第二年疗效相似（P>0.1），但 0.01%阿托品组的疗效略有改善（P=0.04）。对于第 1 阶段安慰剂组，在改用 0.05%阿托品后，近视进展明显减少（SE 变化：第二年为 0.18 D，第一年为 0.82 D[P<0.001]；AL 延长 0.15 mm，第二年为 0.43 mm，第一年为 0.43 mm[P<0.001]）。所有浓度的调节损失和瞳孔大小变化与第一年的结果相似，且耐受性良好。视力和与视力相关的生活质量不受影响。
结论
在 2 年内，0.05%阿托品的疗效是 0.01%阿托品的两倍，并且在研究的阿托品浓度中，它仍然是减缓近视进展的最佳浓度。
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