Xiaoying Li, Wei Ma, Yutong Song, Maurice Yap, Longqian Liu
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引用次数: 0
Abstract
Purpose: To assess the efficacy of the Defocus Incorporated Multiple Segments (DIMS) spectacle lens for myopia control and its impact on vision-related quality of life in Chinese children over a 1-year period. Methods: This randomized double-blind prospective controlled clinical trial enrolled 176 myopic subjects aged between seven and 14 years who were randomly assigned into the DIMS group or the control single-vision (SV) group. Refractive error and axial length measurements at baseline, three-, six-, nine-, and 12-month follow-up visits were monitored. The Quality of Life Impact of Refractive Correction (QIRC) questionnaire was used to evaluate the vision-related quality of life at baseline and at 12 months postintervention. Results: Of the initial cohort, a total of 151 children successfully completed the study (DIMS n = 72; SV n = 79). Baseline characteristics were similar between both groups. Average axial elongation and myopia progression after 1 year were 0.17 (95% CI 0.13-0.20) mm and -0.27 (95% CI -0.36 to -0.18) D in the DIMS group and 0.30 (95% CI 0.26-0.33) mm and -0.55 (95% CI -0.64 to -0.47) D in the SV group. The mean differences in axial elongation and myopia progression were 0.13 mm (95% CI 0.08-0.18 mm, p < 0.001) and -0.28 D (95% CI -0.41 to -0.15 D, p < 0.001) between the two groups. No significant difference in the QIRC score was found between the DIMS and SV groups (55.30 (95% CI 53.17-56.90) versus 54.20 (95% CI 51.99-56.41), p=0.854)). Conclusion: The use of DIMS lenses in children was found to slow down myopia progression compared to SV lenses, without negatively affecting their overall quality of life. Trial Registration: Clinical Trial Registry identifier: ChiCTR2000037443.
目的:评价离焦合并多节段(DIMS)眼镜片对中国儿童1年近视控制的效果及其对视力相关生活质量的影响。方法:采用随机双盲前瞻性对照临床试验,将176名年龄在7 ~ 14岁的近视患者随机分为DIMS组和对照单视力组。对基线、3个月、6个月、9个月和12个月随访时的屈光不正和眼轴长度测量进行监测。使用屈光矫正生活质量影响问卷(QIRC)评估基线和干预后12个月的视力相关生活质量。结果:在初始队列中,共有151名儿童成功完成了研究(DIMS n = 72;SV n = 79)。两组的基线特征相似。1年后,DIMS组的平均眼轴伸长和近视进展为0.17 (95% CI 0.13-0.20) mm和-0.27 (95% CI -0.36 - -0.18) D, SV组为0.30 (95% CI 0.26-0.33) mm和-0.55 (95% CI -0.64 - -0.47) D。两组眼轴伸长和近视进展的平均差异分别为0.13 mm (95% CI 0.08 ~ 0.18 mm, p < 0.001)和-0.28 D (95% CI -0.41 ~ -0.15 D, p < 0.001)。DIMS组和SV组的QIRC评分无显著差异(55.30 (95% CI 53.17-56.90) vs 54.20 (95% CI 51.99-56.41), p=0.854)。结论:与SV隐形眼镜相比,儿童使用DIMS隐形眼镜可以减缓近视的进展,而不会对他们的整体生活质量产生负面影响。试验注册:临床试验注册标识:ChiCTR2000037443。
期刊介绍:
Journal of Ophthalmology is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies related to the anatomy, physiology and diseases of the eye. Submissions should focus on new diagnostic and surgical techniques, instrument and therapy updates, as well as clinical trials and research findings.