To evaluate (1) the long-term efficacy of low-concentration atropine over 5 years, (2) the proportion of children requiring re-treatment and associated factors, and (3) the efficacy of pro re nata (PRN) re-treatment using 0.05% atropine from years 3 to 5. Randomized, double-masked extended trial. Children 4 to 12 years of age originally from the Low-Concentration Atropine for Myopia Progression (LAMP) study. Children 4 to 12 years of age originally from the LAMP study were followed up for 5 years. During the third year, children in each group originally receiving 0.05%, 0.025%, and 0.01% atropine were randomized to continued treatment and treatment cessation. During years 4 and 5, all continued treatment subgroups were switched to 0.05% atropine for continued treatment, whereas all treatment cessation subgroups followed a PRN re-treatment protocol to resume 0.05% atropine for children with myopic progressions of 0.5 diopter (D) or more over 1 year. Generalized estimating equations were used to compare the changes in spherical equivalent (SE) progression and axial length (AL) elongation among groups. (1) Changes in SE and AL in different groups over 5 years, (2) the proportion of children who needed re-treatment, and (3) changes in SE and AL in the continued treatment and PRN re-treatment groups from years 3 to 5. Two hundred seventy (82.8%) of 326 children (82.5%) from the third year completed 5 years of follow-up. Over 5 years, the cumulative mean SE progressions were –1.34 ± 1.40 D, –1.97 ± 1.03 D, and –2.34 ± 1.71 D for the continued treatment groups with initial 0.05%, 0.025%, and 0.01% atropine, respectively ( = 0.02). Similar trends were observed in AL elongation ( = 0.01). Among the PRN re-treatment group, 87.9% of children (94/107) needed re-treatment. The proportion of re-treatment across all studied concentrations was similar ( = 0.76). The SE progressions for continued treatment and PRN re-treatment groups from years 3 to 5 were –0.97 ± 0.82 D and –1.00 ± 0.74 D ( = 0.55) and the AL elongations were 0.51 ± 0.34 mm and 0.49 ± 0.32 mm ( = 0.84), respectively. Over 5 years, the continued 0.05% atropine treatment demonstrated good efficacy for myopia control. Most children needed to restart treatment after atropine cessation at year 3. Restarted treatment with 0.05% atropine achieved similar efficacy as continued treatment. Children should be considered for re-treatment if myopia progresses after treatment cessation. The author(s) have no proprietary or commercial interest in any materials discussed in this article.

中文翻译：

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低浓度阿托品治疗近视进展 (LAMP) 研究的五年临床试验：第 4 期报告


评估(1)低浓度阿托品5年以上的长期疗效，(2)需要再治疗的儿童比例及相关因素，以及(3)Pro re nata (PRN)再治疗的疗效从第 3 至第 5 年使用 0.05% 阿托品。随机、双盲扩展试验。最初来自低浓度阿托品治疗近视进展 (LAMP) 研究的 4 至 12 岁儿童。最初参与 LAMP 研究的 4 至 12 岁儿童被随访了 5 年。在第三年，每组中最初接受0.05%、0.025%和0.01%阿托品的儿童被随机分为继续治疗和停止治疗。在第 4 年和第 5 年，所有继续治疗亚组均改用 0.05% 阿托品继续治疗，而所有治疗停止亚组均遵循 PRN 重新治疗方案，对近视进展达到 0.5 屈光度 (D) 或以上的儿童恢复使用 0.05% 阿托品1年多。使用广义估计方程来比较各组之间球当量（SE）进展和轴长（AL）伸长的变化。 (1) 5年内不同组SE和AL的变化，(2) 需要再治疗的儿童比例，(3) 继续治疗组和PRN再治疗组从3岁起SE和AL的变化到 5。 326 名儿童（82.5%）中的 270 名（82.8%）从第三年开始完成了 5 年的随访。 5 年来，初始使用 0.05%、0.025% 和 0.01% 阿托品的持续治疗组的累积平均 SE 进展分别为 –1.34 ± 1.40 D、–1.97 ± 1.03 D 和 –2.34 ± 1.71 D (= 0.02 ）。 AL 伸长率也观察到类似的趋势 (= 0.01)。在PRN再治疗组中，87.9%的儿童（94/107）需要再治疗。 所有研究浓度的再治疗比例相似 (= 0.76)。从第 3 年到第 5 年，继续治疗组和 PRN 重新治疗组的 SE 进展分别为 –0.97 ± 0.82 D 和 –1.00 ± 0.74 D (= 0.55)，AL 伸长分别为 0.51 ± 0.34 mm 和 0.49 ± 0.32 mm (= 0.84) ）， 分别。 5年来，持续0.05%阿托品治疗显示出良好的近视控制效果。大多数儿童在第 3 年停用阿托品后需要重新开始治疗。使用 0.05% 阿托品重新开始治疗与继续治疗取得了相似的疗效。如果停止治疗后近视继续恶化，应考虑重新治疗儿童。作者对本文讨论的任何材料没有专有或商业利益。