Retardation of Myopia in Orthokeratology (ROMIO) Study: A 2-Year Randomized Clinical Trial
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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ABSTRACT: To evaluate the clinical treatment effects of orthokeratology to slow the progression of myopia. Several well-designed controlled studies have investigated the effects of orthokeratology in school-aged children. We conducted this meta-analysis to better evaluate the existing evidence. Relevant studies were identified in the Medline and Embase database without language limitations. The main outcomes included axial length and vitreous chamber depth reported as the mean ± standard deviation. The results were pooled and assessed with a fixed-effects model analysis. Subgroup analyses were performed according to geographical location and study design. Of the seven eligible studies, all reported axial length changes after 2 years, while two studies reported vitreous chamber depth changes. The pooled estimates indicated that change in axial length in the ortho-k group was 0.27 mm (95% confidence interval [CI]: 0.22, 0.32) less than the control group. Myopic progression was reduced by approximately 45%. The combined results revealed that the difference in vitreous chamber depth between the two groups was 0.22 mm (95% confidence interval [CI]: 0.14, 0.31). None of the studies reported severe adverse events. The overall findings suggest that ortho-k can slow myopia progression in school-aged children.PLoS ONE 04/2015; 10(4):e0124535. DOI:10.1371/journal.pone.0124535 · 3.53 Impact Factor
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ABSTRACT: To determine if 'Defocus Incorporated Soft Contact' (DISC) lens wear slows childhood myopia progression. A 2-year double-blind randomised controlled trial was carried out in 221 children aged 8-13 years, with myopia between -1.00 and -5.00 Dioptres (D) and astigmatism ≤1.00 D. Subjects were randomly assigned to the DISC (n=111) or single vision (SV; n=110) contact lens group. DISC lenses incorporated concentric rings, which provided an addition of +2.50 D, alternating with the normal distance correction. Refractive error (cycloplegic autorefraction) and axial length were measured at 6-month intervals. Differences between groups were analysed using unpaired t test. In total, 128 children completed the study, n=65 in the DISC group and n=63 in the SV group. Myopia progressed 25% more slowly for children in the DISC group compared with those in the control group (0.30 D/year; 95% CI -0.71 to -0.47 vs 0.4 D/year; 95% CI -0.93 to -0.65, p=0.031). Likewise, there was less axial elongation for children in the DISC versus SV groups (0.13 mm/year; 95% CI 0.20 to 0.31 vs 0.18 mm/year; 95% CI 0.30 to 0.43, p=0.009). Treatment effect correlated positively with DISC lens wearing time (r=0.342; p=0.005). Indeed, myopia in children who wore the DISC lenses for five or more hours/day progressed 46% (mean difference=-0.382 D, p=0.001; 95% CI -0.59 to -0.17) less than those in the SV group. The daily wearing of DISC lens significantly slowed myopia progression and axial elongation in Hong Kong schoolchildren. The findings demonstrated that simultaneous clear vision with constant myopic defocus can retard myopia progression.The British journal of ophthalmology 10/2013; 98(1). DOI:10.1136/bjophthalmol-2013-303914 · 2.81 Impact Factor
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ABSTRACT: PURPOSE: To analyze cases of orthokeratology-associated infectious keratitis managed in a tertiary care eye hospital in Hong Kong between 2003 and 2013. DESIGN: Retrospective study. METHODS: Case records of patients with infectious keratitis attributable to orthokeratology contact lenses were analyzed. Data analyzed included clinical features, microbiological evaluation, and treatment outcomes. RESULTS: A total of 23 patients were included (16 female, 7 male, mean age: 15.0 +/- 4.2 years; range: 9-23 years). All patients were using overnight orthokeratology for an average of 2.7 +/- 2.8 years (range: 3 months - 10 years) before the onset of infection. Clinical features included corneal infiltrate (n = 14, 60.9%) and corneal perineuritis (n = 12, 52.2%). Fifteen eyes (65.2%) had a positive microbiological culture obtained from corneal scrapings. The most commonly isolated organism was Pseudomonas aeruginosa (n = 6), followed by coagulase-negative Staphylococcus (n = 5) and Acanthamoeba (n = 3). Five cases of Pseudomonas aeruginosa and 5 cases of Acanthamoeba were identified from contact lenses or contact lens solution. The mean duration from disease onset to remission was 31.9 +/- 34.9 days (range: 6-131 days). All patients responded to medical treatment, and no emergency surgical intervention was needed. The best-corrected logMAR visual acuity improved significantly from 0.62 +/- 0.51 (20/83 Snellen) to 0.15 +/- 0.20 (20/28 Snellen) (Wilcoxon signed rank test, P < .001). CONCLUSIONS: Orthokeratology-associated infectious keratitis continues to be a serious problem, especially in regions with high prevalence of myopia. Early clinical and microbiological diagnosis and intensive treatment can improve final visual outcomes. (C) 2014 by Elsevier Inc. All rights reserved.)American Journal of Ophthalmology 08/2014; 158(6). DOI:10.1016/j.ajo.2014.08.026 · 4.02 Impact Factor