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：

---

用于控制近视进展的扩展焦深镜片的随机临床试验：SEED LVPEI 印度近视研究的结果


目的 通过为期 1 年的随机临床试验，确定大景深 (EDOF) 隐形眼镜对于控制儿童近视进展的功效。方法 104 名 7~15 岁等效球镜屈光度≤−0.50 D 的儿童被随机分配佩戴 SEED 1 dayPure EDOF 中度隐形眼镜（n=48）或单光框架眼镜（n=56）。在基线和 12 个月就诊时确定使用 Shin-Nippon 开放视野自动验光仪的散瞳验光和使用 Lenstar LS 900 的眼轴长度。在最后一次访视期间进行依从性、视觉不适和干燥问卷调查。结果 69 名儿童（对照组：n=38；治疗组：31）完成了 12 个月的随访，各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向伸长分别为0.22±0.03毫米和0.11±0.03毫米。与单光眼镜片相比，SEED 1 dayPure EDOF 中度隐形眼镜根据球面等效屈光度数可将近视加深速度减慢 59% (−0.28D；p=0.01)，控制轴长可减慢 49% (0.11 mm；p=0.007)。没有参与者报告任何不良反应。虽然大多数参与者 (82%) 对隐形眼镜感到舒适，但 11% 的人表示偶尔会感到干燥，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 中型隐形眼镜对控制近视进展和眼轴延长具有显着效果。可根据合理要求提供数据。