眼科 ›› 2025, Vol. 34 ›› Issue (5): 366-370.doi: 10.13281/j.cnki.issn.1004-4469.2025.05.006

• 论著 • 上一篇    下一篇

多区正向光学离焦镜片与单光镜片对6~12岁儿童散光和近视控制的随机对照研究

陈莺1   孙文峰1  甄毅2   

  1. 1中国科学技术大学医院眼科,合肥 230026; 2首都医科大学附属北京同仁医院 北京同仁眼科中心 北京市眼科研究所 国家眼科诊断与治疗工程技术研究中心 眼科诊疗设备与材料教育部工程研究中心 眼科学与视觉科学北京市重点实验室,北京100730

  • 收稿日期:2024-09-08 出版日期:2025-09-25 发布日期:2025-09-12
  • 通讯作者: 甄毅,Email:dr_zhenyi@163.com

A randomized controlled study on myopic and astigmatism control of children aged 6-12 years between single spectacle lenses and defocus incorporated multiple segments spectacle lenses

Chen Ying1, Sun Wenfeng1, Zhen Yi2   

  1. 1 Department of Ophthalmology, University of Science and Technology of China Hospital, Hefei 230026, China;
    2 Natonal Engineering Research Center for Ophthalmology, Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Engineering Research Center of the Ministry of Education for Ophthalmic Diagnosis and Treatment Equipment and Materials, Beijing Tongren Hospital, Capital Medical University; Beijing Key Laboratory of Ophthalmology and Visual Science, Beijing 100730, China

  • Received:2024-09-08 Online:2025-09-25 Published:2025-09-12
  • Contact: Zhen Yi, Email: dr_zhenyi@163.com

摘要:  目的  对比多区正向光学离焦镜片(简称离焦镜片)和单光镜片对儿童散光和近视的影响,明确离焦镜片是否存在增加散光的风险及在近视控制方面的效果。设计  随机对照临床试验。研究对象  2022-2023年中国科学技术大学医院6~12岁近视儿童志愿者102例。方法  招募符合条件的儿童志愿者并随机分为离焦镜片组和单光镜片组(各51例),分别配戴离焦镜片和单光镜片12个月。对两组儿童进行全面眼科检查,包括裂隙灯显微镜检查、睫状肌麻痹后电脑验光、检影验光、主觉验光等确定配镜度数。取右眼数据进行统计分析。主要指标  J0、J45、等效球镜及眼轴变化量。结果  入组时离焦镜片组和单光镜片组在年龄、J0、J45、等效球镜度数、眼轴长度等均无统计学差异。戴镜12个月后,离焦镜片组和单光镜片组J0的变化分别为(0.08±0.13)D和(0.08±0.13)D(t=-0.193,P=0.424);J45的变化分别为(0.01±0.06)D和 (-0.01±0.07)D(t=0.029,P=0.977);等效球镜度变化分别为(-0.51±0.59)D和(-0.74±0.42)D(t=2.229,P=0.014),离焦组等效球镜进展较单光组降低31.1%;眼轴增长分别为(0.25±0.22) mm和(0.39±0.22)mm(t=-3.083,P=0.003),离焦组眼轴增长较单光组眼轴增长减少35.8%。结论 12个月的观察结果显示,与单光镜片相比,多区正向光学离焦镜片不会增加6~12岁儿童散光增长的风险且在控制近视进展方面有一定优势。

关键词: 离焦镜片, 单光镜片, 散光, 近视控制

Abstract:  Objective To compare the effects of defocus incorporated multiple segments spectacle lenses (referred to as defocus lenses) and single-vision lenses on astigmatism and myopia in children and whether defocus lenses increase the risk of astigmatism progression and their efficacy in myopia control.  Design Randomized controlled trial. Participants 102 Volunteers aged 6-12 years with myopia, recruited from University of Science and Technology of China Hospital between 2022 and 2023. Method Eligible children were randomly assigned to the defocus lens group (n=51) or single-vision lens group (n=51) for 12 months. Comprehensive ophthalmic examinations were performed, including slit-lamp microscopy, computer-assisted autorefraction under cycloplegia, retinoscopy, and subjective refraction to determine corrective prescriptions. Main Outcome Measures Changes in J0, J45, spherical equivalent refractive error (SER), and axial length. Results At baseline, there were no statistically significant differences between the defocus group and the single-vision group in terms of age, J0, J45, spherical equivalent refraction, or axial length. After 12 months of lens wear, the changes in J0 were (0.08±0.13) D and (0.08±0.13) D in the defocus and single-vision groups, respectively, with no statistically significant difference between the two groups (t=-0.193, P=0.424). The changes in J45 were (0.01±0.06) D and (-0.01±0.07) D, respectively, with no statistically significant difference between the two groups (t=0.029, P=0.977). The changes in spherical equivalent refraction were (-0.51±0.59) D and (-0.74±0.42) D, respectively, showing a statistically significant difference between the two groups (t=2.229, P=0.014). The progression of spherical equivalent refraction in the defocus group was reduced by 31.1% compared with the single-vision group. The axial elongation was (0.25±0.22) mm and (0.39±0.22) mm, respectively, showing a statistically significant difference between the two groups (t=-3.083, P=0.003). Axial elongation in the defocus group was reduced by 35.8% compared with the single-vision group. Conclusions The 12-month observation results show that compared to single-vision lenses, defocus incorporated multiple segments spectacle lenses do not increase the risk of astigmatism progression and demonstrate superior efficacy in controlling myopia progression of children aged 6-12 years.  

Key words: Defocus lenses, Single-vision lenses, Astigmatism, Myopia control