School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.
Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565.
This single-masked randomized clinical trial aimed to evaluate the effectiveness of orthokeratology (ortho-k) for myopic control.
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.
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.
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.).
本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。
共纳入 102 名符合条件的受试者，年龄 6 至 10 岁，近视屈光度为 0.50 至 4.00 屈光度（D），散光不超过 1.25D，随机分为佩戴角膜塑形镜或单焦点眼镜组，为期 2 年。眼轴长度由一名蒙面检查者通过眼内晶状体计算进行测量，在基线和每 6 个月进行一次。本研究在 ClinicalTrials.gov 注册，编号为 NCT00962208。
共有 78 名受试者（角膜塑形镜组 37 名，对照组 41 名）完成了研究。在 2 年结束时，角膜塑形镜组和对照组的平均眼轴延长量分别为 0.36±0.24mm 和 0.63±0.26mm，角膜塑形镜组的眼轴延长速度明显较慢（P<0.01）。眼轴延长与初始近视无相关性（P>0.54），但与受试者的初始年龄相关（P<0.001）。在对照组中，年龄较小（7-8 岁）和较大（9-10 岁）的儿童中，近视进展较快（每年>1.00D）的比例分别为 65%和 13%，而在角膜塑形镜组中，分别为 20%和 9%。5 名受试者因不良事件停止了角膜塑形治疗。
平均而言，佩戴角膜塑形镜的受试者眼轴延长速度比佩戴单焦点眼镜的受试者慢 43%。年龄较小的儿童眼轴延长速度较快，可能受益于早期的角膜塑形治疗。（ClinicalTrials.gov 编号，NCT00962208）。
