Importance Slowing myopia progression could decrease the risk of sight-threatening complications. Objective To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses. Design, Setting, and Participants A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019. Interventions Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses. Main Outcomes and Measures The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth. Results Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39 [1.00] D). Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, -0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was -0.23 mm (95% CI, -0.30 to -0.17) for high add power vs single vision, -0.16 mm (95% CI, -0.23 to -0.09) for high add vs medium add power, and -0.07 mm (95% CI, -0.14 to -0.01) for medium add power vs single vision. Conclusions and Relevance Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences. Trial Registration ClinicalTrials.gov Identifier: NCT02255474.

中文翻译：

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高附加焦度、中附加焦度或单光隐形眼镜对儿童近视进展的影响

重要性 减缓近视进展可以降低威胁视力的并发症的风险。目的 确定软性多焦点隐形眼镜是否能减缓儿童近视进展，以及高附加度数 (+2.50 D) 是否比中度数 (+1.50 D) 附加度数镜片更能减缓近视进展。设计、设置和参与者 在位于俄亥俄州哥伦布市和德克萨斯州休斯顿市的 2 所验光学校进行的双盲随机临床试验。2014年9月22日至2016年6月20日，共纳入294名符合条件的7～11岁球形成分近视-0.75 D～-5.00 D、散光小于1.00 D的儿童。随访于6月完成。 2019 年 24 日。 干预措施 参与者被随机分配佩戴高附加功率 (n = 98)、中等附加功率 (n = 98)、或单光 (n = 98) 隐形眼镜。主要结果和测量 主要结果是散瞳等效球面自验光的 3 年变化，以 10 次自验光读数的平均值衡量。有 11 个次要终点，其中 4 个用于本研究分析，包括 3 年眼睛生长。结果 在 294 名随机参与者中，292 名 (99%) 被纳入分析（平均 [SD] 年龄，10.3 [1.2] 岁；177 [60.2%] 名女性；平均 [SD] 球面等效屈光不正，-2.39 [1.00] ] D)。调整后的 3 年近视进展为高附加度为 -0.60 D，中等附加度为 -0.89 D，单光隐形眼镜为 -1.05 D。高附加度与单视的进展差异为 0.46 D（95% CI，0.29-0.63），高附加度与中等附加度为 0.30 D（95% CI，0.13-0.47），0.16 D（95% CI） ，-0。01 到 0.33) 用于中等强度与单视。在 4 个次要终点中，有 3 个终点在组间没有统计学显着差异。调整后的平均眼睛生长为高附加度为 0.42 毫米，中等附加度为 0.58 毫米，单视为 0.66 毫米。高附加焦度与单视的眼睛生长差异为 -0.23 mm（95% CI，-0.30 至 -0.17），高附加焦度与中等附加焦度的差异为 -0.16 mm（95% CI，-0.23 至 -0.09），和 -0.07 毫米（95% CI，-0.14 至 -0.01），用于中等强度与单视。结论和相关性 在近视儿童中，与中度数多焦点和单光隐形眼镜相比，高倍数多焦点隐形眼镜治疗在 3 年内显着降低了近视进展速度。然而，需要进一步研究以了解观察到的差异的临床重要性。试验注册 ClinicalTrials.gov 标识符：NCT02255474。