Retardation of Myopia in Orthokeratology (ROMIO) Study: A 2-Year Randomized Clinical Trial
Retardation of Myopia in Orthokeratology (ROMIO) Study: A 2-Year Randomized Clinical Trial
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DOI：
10.1167/iovs.12-10565
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发表时间：
2012-10-01
影响因子：
4.4
通讯作者：
Cheung, Sin-Wan
中科院分区：
文献类型：
--
作者：
Cho, Pauline;Cheung, Sin-Wan
目的.这项单盲随机临床试验旨在评估角膜塑形术（ortho-k）对近视控制的有效性。共102例符合条件的受试者，年龄范围为6至10岁，近视度数为0.50至4.00 D，散光不超过1.25 D，随机分配配戴ortho-k镜片或单视眼镜，为期2年。眼轴长度由设盲的检查者通过计算眼内透镜进行测量，并在基线和每6个月进行一次。本研究在www.example.com上注册，编号为NCT 00962208。共有78名受试者（ortho-k组37名，对照组41名）完成了研究。在2年结束时，ortho-k组和对照组的平均轴向伸长分别为0.36 +/-0.24和0.63 +/-0.26 mm，ortho-k组明显较慢（P <0.01）。眼轴延长与初始近视无相关性（P> 0.54），但与初始年龄相关（P <0.001）。在对照组中，年龄较小（年龄范围：7 - 8岁）和年龄较大（年龄范围：9 - 10岁）的儿童中，近视快速进展（每年> 1.00 D）的受试者百分比分别为65%和13%，在ortho-k组中分别为20%和9%。5名受试者因不良事件而停止ortho-k治疗。平均而言，与戴单视眼镜的受试者相比，戴角膜塑形镜的受试者的眼轴伸长增加较慢，增幅为43%。年龄较小的儿童往往有更快的轴向伸长，并可能受益于早期ortho-k治疗。（ClinicalTrials.gov编号，NCT 00962208。）（Invest Ophthalmol维斯科学。2012; 53：7077 - 7085）DOI：10.1167/iovs.12 - 10565
PURPOSE. This single-masked randomized clinical trial aimed to evaluate the effectiveness of orthokeratology (ortho-k) for myopic control.METHODS. A total of 102 eligible subjects, ranging in age from 6 to 10 years, with myopia between 0.50 and 4.00 diopters (D) and astigmatism not more than 1.25D, were randomly assigned to wear ortho-k lenses or single-vision glasses for a period of 2 years. Axial length was measured by intraocular lens calculation by a masked examiner and was performed at the baseline and every 6 months. This study was registered at ClinicalTrials.gov, number NCT00962208.RESULTS. In all, 78 subjects (37 in ortho-k group and 41 in control group) completed the study. The average axial elongation, at the end of 2 years, were 0.36 +/- 0.24 and 0.63 +/- 0.26 mm in the ortho-k and control groups, respectively, and were significantly slower in the ortho-k group (P < 0.01). Axial elongation was not correlated with the initial myopia (P > 0.54) but was correlated with the initial age of the subjects (P < 0.001). The percentages of subjects with fast myopic progression (> 1.00D per year) were 65% and 13% in younger (age range: 7-8 years) and older (age range: 9-10 years) children, respectively, in the control group and were 20% and 9%, respectively, in the ortho-k group. Five subjects discontinued ortho-k treatment due to adverse events.CONCLUSIONS. On average, subjects wearing ortho-k lenses had a slower increase in axial elongation by 43% compared with that of subjects wearing single-vision glasses. Younger children tended to have faster axial elongation and may benefit from early ortho-k treatment. (ClinicalTrials.gov number, NCT00962208.) (Invest Ophthalmol Vis Sci. 2012;53:7077-7085) DOI:10.1167/iovs.12-10565