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Retardation of Myopia in Orthokeratology (ROMIO) Study: A 2-Year Randomized Clinical Trial Pauline Cho and Sin-Wan Cheung

This Study was a featured piece of research in the October 2012 issue of  investigative Opthomalogy and Visual Science. It is a key piece of research into overnight contact lenses for children and it concludes that the children wearing overnight ortho-k lenses had a slower increase in eye elongation by 43% compared with that of children wearing single-vision prescription glasses. The development of myopia in younger children tends to be much faster and these children the study concludes, may benefit most from early myopia treatment using overnight ortho-k lenses. The study was carried out in Hong Kong where the rise of myopia in children is highest with around 90% of school leavers in asian cities suffreing from myopia. 
 
 
Pauline Cho and Sin-Wan Cheung
School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, China
 
Abstract

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.)
 
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