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Abstract
Aim To determine if ‘Defocus Incorporated Multiple Segments’ (DIMS) spectacle lenses slow childhood myopia progression.
Methods A 2-year double-masked randomised controlled trial was carried out in 183 Chinese children aged 8–13 years, with myopia between −1.00 and −5.00 D and astigmatism ≤1.50 D. Children were randomly assigned to wear DIMS (n=93) or single vision (SV) spectacle lenses (n=90). DIMS lens incorporated multiple segments with myopic defocus of +3.50 D. Refractive error (cycloplegic autorefraction) and axial length were measured at 6month intervals.
Results 160 children completed the study, n=79 in the DIMS group and n=81 in the SV group. Average (SE) myopic progressions over 2 years were −0.41±0.06 D in the DIMS group and −0.85±0.08 D in the SV group. Mean (SE) axial elongation was 0.21±0.02 mm and 0.55±0.02 mm in the DIMS and SV groups, respectively. Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference −0.44±0.09 D, 95% CI −0.73 to −0.37, p<0.0001). Likewise, children in the DIMS group had less axial elongation by 62% than those in the SV group (mean difference 0.34±0.04 mm, 95% CI 0.22 to 0.37, p<0.0001). 21.5% children who wore DIMS lenses had no myopia progression over 2 years, but only 7.4% for those who wore SV lenses.
Conclusions Daily wear of the DIMS lens significantly retarded myopia progression and axial elongation in myopic children. Our results demonstrated simultaneous clear vision with constant myopic defocus can slow myopia progression.
Trial registration number NCT02206217.
- myopia
- myopic defocus
- myopia control
- simultaneous vision
- spectacle lens
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Footnotes
Contributors All the authors listed have been involved in the undertaking of the clinical trial with emphasis on various aspects, from the conception of the lens design, fabrication of the lens and registration of the clinical trial and preparation of clinical protocol to data collection and analysis, interpretation and conclusions. A few manuscripts are now in preparation by the author team.
Funding This was a collaborative research supported by HOYA, Tokyo, Japan (PolyU grant numbers H-ZG3B and 1-87LK). In addition to the financial support, the sponsor also provided manufacturing spectacle lenses and frames. It was a joint collaboration in the design of the DIMS lens.
Competing interests None. Patents titled ‘Spectacle Lens' in China (CN104678572 B) and in USA (US10268050 B2) were issued on 27 April 2018 and 23 April 2019 respectively.
Patient consent for publication Not required.
Ethics approval All aspects of the study met the tenets of the Declaration of Helsinki and were approved by the Human Subjects Ethics Subcommittee of the Hong Kong Polytechnic University.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data are available upon request.
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