Purpose
To report the results of 12-month wear of three novel spectacle lens designs intended to reduce peripheral hyperopic defocus and one standard design control lens and their effect on the progression of myopia in Chinese children aged 6 to 16 years.
Methods
Chinese children (n = 210) with myopia (−0.75 D to −3.50 D sphere, cylinder ≤−1.50 D) were randomized to one of four groups wearing either one of three novel spectacle lens designs (types I, II, or III) or conventional, single-vision spectacle lenses. Data were collected at 6 and 12 months. Primary and secondary outcome measures were the changes in central cycloplegic auto-refraction and eye axial length, respectively. Peripheral refraction along the horizontal meridian (nasal and temporal) was taken at baseline with and without spectacle lenses. Multivariate linear regression was used to adjust analyses for important covariates.
Results
Progression in eyes wearing control spectacle lenses at 6 and 12 months was −0.55 D ± 0.35 D and −0.78 ± 0.50 D, respectively. For the entire group, no statistically significant differences were observed in the rates of progression with the novel designs in comparison to control spectacle lenses. However, in younger children (6 to 12 years) with parental history of myopia (n = 100), there was significantly less progression (−0.68 D ± 0.47 D vs. −0.97 D ± 0.48 D) with lens type III compared with control spectacles (mean difference, 0.29 D, std error, 0.11, p = 0.038).
Conclusions
There were no statistically significant differences in the rate of progression of myopia between the control and novel lens wearing eyes for the age group 6 to 16 years. The finding of reduced progression of myopia with type III lens design in younger children with parental myopia needs to be validated in a more targeted study.
To the extent that has been tested and that can be tolerated by wearers of spectacle lenses, the high positive aspherization of the distance zone added to PALs does not enhance their therapeutic efficacy in slowing myopia progression. (http://www.anzctr.org.au/ number, ACTRN12608000566336).
The results of this clinical trial could not verify the therapeutic effect of MyoVision for slowing down myopia progression in Japanese children. Additional studies are needed to design lenses that can reduce peripheral hyperopic defocus individually and to examine the effectiveness of these lenses in preventing myopia progression.
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