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.
Institute for Eye Research, Sydney, New South Wales, Australia (PS, LD, AH, AM, BH), Vision Co-operative Research Centre, Sydney, New South Wales, Australia (PS, LD, AH, AM, BH), School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia (PS, AH, XC, JG, BH), Carl Zeiss Vision, Adelaide, South Australia, Australia (SV, SF), International Clinical Trials Center, Zhongshan Ophthalmic Centre, SunYat Sen University, Guangzhou, People's Republic of China (XC, ZL, JG), and College of Optometry, University of Houston, Houston, Texas (ELS).
The study was funded by the Co-operative Research Centre Program, Australian Federal Government; Institute for Eye Research, Sydney, Australia and Vision CRC, Australia. Lenses were supplied by Carl Zeiss Vision and the study carried out at the International Clinical Trials Center, Zhongshan Ophthalmic Center, at Sun Yet Sen University in Guangzhou China.
Received November 8, 2009; accepted May 14, 2010.