title: Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial.
abstract: OBJECTIVE
  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.).
authors.affiliation: School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.
authors.forename: Pauline
authors.initials: P
authors.lastname: Cho
authors.forename: Sin-Wan
authors.initials: SW
authors.lastname: Cheung
mesh_terms: D001251:Astigmatism / Q000628:therapy*; D002648:Child; D018450:Disease Progression; D005139:Eyeglasses / Q000009:adverse effects; D005260:Female; D006723:Hong Kong; D006801:Humans; D016014:Linear Models; D008297:Male; D009216:Myopia / Q000628:therapy*; D054158:Orthokeratologic Procedures / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome