Purpose To determine the efficacy of extended depth of focus (EDOF) contact lenses for controlling myopia progression in children through a 1-year randomised clinical trial. Methods A total of 104 children aged 7–15 years, with spherical equivalent refraction ≤−0.50 D, were randomly assigned to wear SEED 1 dayPure EDOF Mid contact lenses (n=48) or single vision spectacle lenses (n=56). Cycloplegic refraction with Shin-Nippon open field autorefractor and axial length with Lenstar LS 900 was determined at the baseline and 12-month visits. The compliance, visual discomfort and dryness questionnaires were administered during the final visit. Results Sixty-nine children (control: n=38; treatment: 31) completed the 12-month follow-up visit, with no difference in baseline characteristics between the groups. Mean (SEM) myopia progression in the 12th month was −0.48±0.07D in the control group and −0.20±0.08D in the treatment group. Mean axial elongation was 0.22±0.03 mm and 0.11±0.03 mm in the control and treatment groups, respectively. SEED 1 dayPure EDOF Mid contact lenses slowed myopia progression by 59% (−0.28D; p=0.01) based on spherical equivalent refraction and controlled axial length by 49% (0.11 mm; p=0.007) in comparison to single vision spectacle lenses. None of the participants reported any adverse effects. While most of the participants (82%) were comfortable with the contact lenses, 11% reported occasional dryness and 14% experienced mild fluctuations in visual acuity after immediate lens wear. Conclusion Daily wear of SEED 1 dayPure EDOF Mid contact lenses in Indian children showed a significant effect in controlling myopia progression and axial elongation. Data are available on reasonable request.

中文翻译：

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用于控制近视加深镜片的随机临床试验：SEED LVPEI 印度近视研究的结果


目的 通过一项为期 1 年的随机临床试验确定扩展焦深 （EDOF） 隐形眼镜控制儿童近视加深的疗效。方法 共 104 名年龄在 7-15 岁之间、等效屈光度为 ≤−0.50 D） 的儿童被随机分配佩戴 SEED 1 dayPure EDOF 中隐形眼镜 （n=48） 或单光眼镜片 （n=56）。在基线和 12 个月访视时确定 Shin-Nippon 开场自动验光仪的睫状肌麻痹屈光和使用 Lenstar LS 900 的眼轴长度。在最后一次访问期间进行了依从性、视觉不适和干燥问卷。结果 69 例儿童 （对照： n=38;治疗： 31） 完成了 12 个月的随访，两组之间的基线特征没有差异。对照组第 12 个月的平均 （SEM） 近视进展为 -0.48±0.07D，治疗组为 -0.20±0.08D。对照组和治疗组的平均轴伸长分别为 0.22±0.03 mm 和 0.11±0.03 mm。与单光眼镜片相比，SEED 1 天纯 EDOF 中隐形眼镜根据球面等效屈光度和轴长控制了 49%（0.11 mm;p=0.07），近视进展减缓了 59%（-0.28D;p=0.01）。没有参与者报告任何不良反应。虽然大多数参与者 （82%） 对隐形眼镜感到满意，但 11% 的人报告偶尔干燥，14% 的人在立即佩戴隐形眼镜后出现视力轻微波动。结论 印度儿童每日佩戴 SEED 1 dayPure EDOF 中隐形眼镜对控制近视加深和眼轴伸长有显著效果。数据可应合理要求提供。