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阿托品联合角膜塑形术控制近视:研究设计与初步结果。

Combined Atropine with Orthokeratology for Myopia Control: Study Design and Preliminary Results.

机构信息

a School of Optometry , The Hong Kong Polytechnic University , Hung Hom , Hong Kong.

b Department of Ophthalmology , The University of Hong Kong , Hong Kong.

出版信息

Curr Eye Res. 2019 Jun;44(6):671-678. doi: 10.1080/02713683.2019.1568501. Epub 2019 Jan 24.

Abstract

: The purpose of this study is to present the study design and one month's preliminary results of a 2-year randomized trial, Combined Atropine with Orthokeratology (AOK), for myopia control study. : Children aged 6 to <11 years and with 1.00-4.00 D myopia were randomly assigned to AOK group or ortho-k alone (OK) group. Subjects are required to attend routine ortho-k aftercare visits (first-overnight, 1 week, 2 weeks, 3 weeks, 1 month, and every 3 months after commencement of lens wear). Clinical outcomes, including lens performance, changes in refractive error, unaided vision, ocular adverse events, corneal staining, lens binding and centration, and axial length, are also assessed at 6-monthly data collection visit. : Data of 30 AOK and 34 OK subjects who had completed the 1-month visit were analyzed. No significant differences in baseline data were found between the two groups ( > 0.05). At the 1-month visit, first-fit success rate was 95%, with full myopia reduction. Mild corneal staining was observed in 23.3% and 30.9% and mild self-reported lens binding in 50% and 41% in AOK and OK groups, respectively, after 1-month lens wear. Mean (±standard deviation) change in axial length was significantly higher in AOK than OK subjects (AOK: -0.05 ± 0.05 mm; OK: -0.02 ± 0.03 mm) ( = 0.003). : After 1 month of treatment, first-fit success rate of ortho-k lenses was high in both groups of subjects; addition of 0.01% atropine in AOK subjects did not affect the lens performance or clinical responses. These results provide the assurance that it is acceptable to continue this longitudinal study, as longer study duration, usually 2 years, is required to determine the effectiveness of treatment for myopia control.

摘要

本研究旨在介绍一项为期 2 年的随机试验的研究设计和一个月的初步结果,即联合阿托品与角膜塑形术(AOK)用于近视控制研究。研究对象为年龄在 6 至<11 岁、近视 1.00-4.00D 的儿童。将他们随机分配至 AOK 组或角膜塑形镜(OK)组。要求受试者在常规角膜塑形镜的随访(第一晚、1 周、2 周、3 周、1 个月和开始戴镜后每 3 个月)后进行随访。还在 6 个月的数据收集时评估临床结果,包括镜片性能、屈光度变化、裸眼视力、眼部不良事件、角膜染色、镜片绑定和中心定位以及眼轴长度。共分析了 30 名 AOK 组和 34 名 OK 组完成 1 个月随访的患者的数据。两组患者的基线数据无显著差异(>0.05)。在 1 个月随访时,AOK 组和 OK 组的初次适配成功率分别为 95%和 94%,均实现了完全近视矫正。AOK 组和 OK 组分别有 23.3%和 30.9%的患者出现轻度角膜染色,50%和 41%的患者出现轻度自述镜片绑定。AOK 组的眼轴平均(±标准差)变化显著高于 OK 组(AOK:-0.05±0.05mm;OK:-0.02±0.03mm)(=0.003)。经过 1 个月的治疗,两组患者的角膜塑形镜初次适配成功率均较高;在 AOK 组受试者中添加 0.01%的阿托品并未影响镜片性能或临床反应。这些结果表明,在较长的研究时间(通常为 2 年)内确定治疗近视控制的效果之前,可以继续进行这项纵向研究。

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