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.).
SourceAvailable from: António Queirós[Show abstract] [Hide abstract]
ABSTRACT: To evaluate the impact of eye and head rotation in the measurement of peripheral refraction with an open-field autorefractometer in myopic eyes wearing two different center-distance designs of multifocal contact lenses (MFCLs).Contact Lens & Anterior Eye 12/2014; 38(2). DOI:10.1016/j.clae.2014.11.201 · 2.00 Impact Factor
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ABSTRACT: To retrospectively compare axial elongation in children with different degrees of myopia wearing spectacles and undergoing ortho-k treatment. The medical records of 128 patients who were fitted with spectacles or orthokeratology (ortho-k) lenses in our clinic between 2008 and 2009 were reviewed. Ortho-k group comprised 65 subjects and 63 subjects wearing spectacles were included in the control group. Subjects were also divided into low-myopia, moderate-myopia and high-myopia groups, based on the basic spherical equivalent refractive error. Axial length periodically measured over 2-year of lens wear and changes in axial length were compared between treatment groups and between subgroups with different degrees of myopia. The control group exhibited more changes in axial length than the ortho-k group at both 12 months (0.39 +/- 0.21 mm vs 0.16 +/- 0.17 mm, p <0.001) and 24 months (0.70 +/- 0.35 mm vs 0.34 +/- 0.29 mm, p <0.001). Axial length elongation was estimated to be slower by about 51% in the ortho-k group. Similar results were found for the subgroups (49%, 59% and 46% reductions, respectively). In the group with low and moderate myopia, the annual increases in axial length were significantly different between the ortho-k and control groups during both the first ( Low myopia: 0.19 +/- 0.17 mm vs 0.40 +/- 0.18 mm, p = 0.001; Moderate myopia: 0.14 +/- 0.18 mm vs 0.45 +/- 0.22 mm, p <0.001) and second ( Low myopia: 0.18 +/- 0.14 mm vs 0.32 +/- 0.19 mm, p = 0.012; Moderate myopia: 0.18 +/- 0.16 mm vs 0.34 +/- 0.30 mm, p = 0.030) years. In the high myopia groups, significant differences were only found between the ortho-k and control groups during the first year (0.16 +/- 0.18 mm vs 0.34 +/- 0.22 mm, p = 0.004). The 2-year axial elongation was significantly associated with initial age (p <0.001) and treatment (p <0.001), but not with gender, initial refractive error, initial axial length, initial corneal curvature. This 2-year study indicates that ortho-k contact lens wear is effective for reducing myopia progression in children with low, moderate and high myopia.BMC Ophthalmology 11/2014; 14(1):141. DOI:10.1186/1471-2415-14-141 · 1.08 Impact Factor
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ABSTRACT: To investigate the effect of overnight orthokeratology (OK) contact lens wear on axial length growth in East Asian children with progressive myopia. A prospective, randomized, contralateral-eye crossover study conducted over a 1-year period. We enrolled 26 myopic children (age range, 10.8-17.0 years) of East Asian ethnicity. Subjects were fitted with overnight OK in 1 eye, chosen at random, and conventional rigid gas-permeable (GP) lenses for daytime wear in the contralateral eye. Lenses were worn for 6 months. After a 2-week recovery period without lens wear, lens-eye combinations were reversed and lens wear was continued for a further 6 months, followed by another 2-week recovery period without lens wear. Axial eye length was monitored at baseline and every 3 months using an IOLMaster biometer. Corneal topography (Medmont E300) and objective refraction (Shin-Nippon NVision-K 5001 autorefractor) were also measured to confirm that OK lens wear was efficacious in correcting myopia. Axial length elongation and myopia progression with OK were compared with conventional daytime rigid contact lens wear. After 6 months of lens wear, axial length had increased by 0.04±0.06 mm (mean ± standard deviation) in the GP eye (P = 0.011) but showed no change (-0.02±0.05 mm) in the OK eye (P = 0.888). During the second 6-month phase of lens wear, in the OK eye there was no change from baseline in axial length at 12 months (-0.04±0.08 mm; P = 0.218). However, in the GP eye, the 12-month increase in axial length was significant (0.09±0.09 mm; P < 0.001). The GP lens-wearing eye showed progressive axial length growth throughout the study. These results provide evidence that, at least in the initial months of lens wear, overnight OK inhibits axial eye growth and myopia progression compared with conventional GP lenses. Apparent shortening of axial length early in OK lens wear may reflect the contribution of OK-induced central corneal thinning, combined with choroidal thickening or recovery due to a reduction or neutralization of the myopiogenic stimulus to eye growth in these myopic children. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.Ophthalmology 11/2014; 122(3). DOI:10.1016/j.ophtha.2014.09.028 · 6.17 Impact Factor