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Pauline Cho, Sin-Wan Cheung; Retardation of Myopia in Orthokeratology (ROMIO) Study: A 2-Year Randomized Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2012;53(11):7077-7085. doi: 10.1167/iovs.12-10565.
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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.)
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