Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years

Abstract

This study evaluated the long-term myopia control effect and safety in children wearing Defocus Incorporated Multiple Segments (DIMS) spectacle lenses. Participants who completed the 2-year RCT were followed for a total of 6 years; their cycloplegic refractions and axial length were measured. Group 1 (n = 36) wore DIMS spectacles for 6 years; Group 2 (n = 14) wore DIMS lens for the first 3.5 years and SV spectacles afterwards; Group 3 (n = 22) wore SV spectacles in the first 2 years and switched to DIMS; Group 4 (n = 18) wore SV spectacles in the first 2 years, switched to DIMS for 1.5 years and then SV spectacles again. Group 1 showed no significant differences in myopia progression (− 0.52 ± 0.66 vs. − 0.40 ± 0.72D) and axial elongation (0.32 ± 0.26 vs. 0.28 ± 0.28 mm, both p > 0.05) between the first and the later 3 years. In the last 2.5 years, DIMS lens groups (Groups 1 and 3) had less myopia progression and axial elongation than the single vision groups (Groups 2 and 4). There was no evidence of rebound after stopping the treatment. Post-wear visual functions in all groups were within norms. The results supported that DIMS lenses provided sustained myopia control without adverse effects over the 6-year study period.Trial registration: clinicaltrials.gov; NCT02206217.

Six‐year cumulative treatment effect and treatment efficacy of a dual focus myopia control contact lens

“…15 This change at 36 months eliminated direct comparison between the observed axial growth of treated eyes during Years 4-6 and a concurrent control group of untreated eyes; a situation faced by others in the myopia control field who conduct clinical trials beyond initial proof of efficacy. 29 This analysis examined some alternative approaches for estimating efficacy in the absence of the concurrent control by employing prior reported average myopic 19 and emmetropic 17 axial growth as comparators (Figure 1), and also examining the delay in time to progress by criterion amounts (Figures 1 and 2). These approaches allowed the accumulated treatment effects of the dual focus contact lens to be assessed over the full 6 years of treatment (Table 1).…”

Assessing the rebound phenomenon in different myopia control treatments: A systematic review

“…The sex distribution was 797 females (46.7%) and 907 males (53.2%). Patient follow-up ranged from 12 25,26 to 72 months, 27 with a mean follow-up of 26.1 ± 16.7 months. Regarding study group intervention, different myopia control therapies were used, such as atropine, 26,[28][29][30] soft multifocal CL, 16,25 DIMS/ HAL spectacles, 27,31 Ortho-K 32 and LLLT.…”

“…Patient follow-up ranged from 12 25,26 to 72 months, 27 with a mean follow-up of 26.1 ± 16.7 months. Regarding study group intervention, different myopia control therapies were used, such as atropine, 26,[28][29][30] soft multifocal CL, 16,25 DIMS/ HAL spectacles, 27,31 Ortho-K 32 and LLLT. 33,34 Concerning the control group intervention, placebo, 26,[28][29][30] single-vision spectacles 27,[31][32][33][34][35] and single-vision CL 25 were used.…”

“…Regarding study group intervention, different myopia control therapies were used, such as atropine, 26,[28][29][30] soft multifocal CL, 16,25 DIMS/ HAL spectacles, 27,31 Ortho-K 32 and LLLT. 33,34 Concerning the control group intervention, placebo, 26,[28][29][30] single-vision spectacles 27,[31][32][33][34][35] and single-vision CL 25 were used. The washout period of myopia control therapies ranged from 1 month 36 to 30 months, 27 with a mean washout period of 10.2 ± 7.4 months.…”

“…33,34 Concerning the control group intervention, placebo, 26,[28][29][30] single-vision spectacles 27,[31][32][33][34][35] and single-vision CL 25 were used. The washout period of myopia control therapies ranged from 1 month 36 to 30 months, 27 with a mean washout period of 10.2 ± 7.4 months. Six studies reported no conflicts of interest (CoI), 16,26,28,29,32,34 while five studies reported CoI by the authors.…”