目的：探讨周边离焦设计硬性透气性角膜接触镜(RGPCL)对6-12岁高度近视儿童近视进展的控制效果，并与传统单光RGPCL及单光框架镜进行比较。

方法：本研究为前瞻性队列研究。纳入2022年1月至2023年1月期间就诊于西安市第一医院眼视光中心的6-12岁高度近视儿童。根据监护人自主选择分为三组：离焦RGPCL组、单光RGPCL组及单光框架镜组。比较戴镜前，戴镜后0.5、1、1.5、2 a眼轴长度(AL)和睫状肌麻痹下等效球镜(SE)，并计算各组AL和SE延缓率。

结果：本研究共纳入高度近视儿童90例180眼，无失访。离焦RGPCL组30例60眼，其中男12例，女18例，平均年龄9.96±1.56岁； 单光RGPCL组30例60眼，其中男15例，女15例，平均年龄9.40±1.52岁； 单光框架镜组30例60眼，其中男14例，女16例，平均年龄9.80±1.37岁。戴镜后0.5、1、1.5、2 a，三组儿童的AL和SE均较戴镜前增加(均P<0.05)，离焦RGPCL组的AL和SE增长量均显著低于单光RGPCL组和单光框架镜组(均P<0.05)。戴镜后2 a，离焦RGPCL组AL增长量为0.22±0.24 mm，SE增长量为0.70±0.70 D； 单光RGPCL组分别为0.49±0.38 mm和1.34±0.60 D； 单光框架镜组分别为0.50±0.21 mm和1.72±0.47 D。以单光框架镜组为对照，离焦RGPCL组在戴镜后2 a时的AL延缓率为56.0%，SE度数延缓率为59.3%。

结论：对于6-12岁高度近视儿童，离焦RGPCL能有效且显著地延缓AL增长和SE进展，其控制效果明显优于单光RGPCL和单光框架镜。离焦RGPCL可作为高度近视儿童的一种有效光学干预方案。

METHODS:This prospective cohort study enrolled children aged 6-12 y with high myopia who visited the Ophthalmology and Optometry Center of Xi'an No.1 Hospital between January 2022 and January 2023. Based on parental preference, participants were divided into three groups: defocused RGPCL group, single-vision RGPCL group, and single-vision spectacles group. The axial length(AL)and cycloplegic spherical equivalent(SE)refraction were compared at baseline, 0.5, 1, 1.5, and 2 y after lens wear. Additionally, AL and SE delay rates were calculated for each group.

RESULTS: This study enrolled a total of 90 children with high myopia(180 eyes), with no participants lost to follow-up. Participants were allocated into three groups based on parental preference. Thirty children(60 eyes)were assigned to the peripheral defocus RGPCL group, consisting of 12 boys and 18 girls with a mean age of 9.96±1.56 y; 30 children(60 eyes)to the single-vision RGPCL group, including 15 boys and 15 girls with a mean age of 9.40±1.52 y; and 30 children(60 eyes)to the single-vision spectacles group, with 14 boys and 16 girls and a mean age of 9.80±1.37 y. At 0.5, 1, 1.5, and 2 y lens fitting, AL and SE increased significantly in all three groups(all P<0.05), with the growth rates in the defocused RGPCL group being significantly lower than those in the single-vision RGPCL and single-vision spectacles groups(all P<0.05). At 2 y lens fitting, the AL elongation was 0.22±0.24 mm and the mean SE progression was 0.70±0.70 D in the peripheral defocus RGPCL group; 0.49±0.38 mm and 1.34±0.60 D in the single-vision RGPCL group; and 0.50±0.21 mm and 1.72±0.47 D in the single-vision spectacles group. Using the single-vision spectacles group as the control, the AL delay rate and SE delay rate at 2 y lens fitting were 56.0% and 59.3%, respectively, in the defocused RGPCL group.

CONCLUSION:For children with high myopia aged 6-12 y, defocus RGPCLs can effectively and significantly delay AL elongation and SE progression, demonstrating markedly superior control efficacy compared to single-vision RGPCL or single-vision spectacles. Defocused RGPCL can serve as an effective optical intervention for high myopia children.