Dataset Information

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.

SUBMITTER: Lam CSY

PROVIDER: S-EPMC10073092 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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

Lam Carly Siu Yin CSY Tang Wing Chun WC Zhang Han Yu HY Lee Paul H PH Tse Dennis Yan Yin DYY Qi Hua H Vlasak Natalia N To Chi Ho CH

Scientific reports 20230404 1

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 ...[more]

PMID: 37015996

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Project description:The aim of this study is to investigate if baseline relative peripheral refraction (RPR) influences the myopia control effects in Chinese myopic children wearing Defocus Incorporated Multiple Segments (DIMS) lenses. Peripheral refraction at 10°, 20°, and 30° nasal (10 N, 20 N, 30 N) and temporal (10 T, 20 T, 30 T) retina were measured at six-month intervals for children who participated in a 2-year randomized controlled trial. The relationship between the baseline peripheral refractions and myopia progression and axial length changes were analysed. A total of 79 children and 81 children in the DIMS and single vision (SV) group were investigated, respectively. In the DIMS group, more baseline myopic RPR spherical equivalent (SE) was associated with more myopic progression (10 N: r = 0.36, p = 0.001; 20 N: r = 0.35, p = 0.001) and greater axial elongation (10 N: r = −0.34, p = 0.001; 20 N: r = −0.29, p = 0.006) after adjusting for co-factors. In the SV group, baseline RPR had association with only myopia progression (10 N: r = 0.37, p = 0.001; 20 N: r = 0.36, p = 0.001; 30 N: r = 0.35, p = 0.002) but not with axial elongation after Bonferroni correction (p > 0.008). No statistically significant relationship was found between temporal retina and myopia progression or axial elongation in both groups. Children with baseline myopic RPR had statistically significant more myopia progression (mean difference around −0.40 D) and more axial elongation (mean difference 0.15 mm) when compared with the children having baseline hyperopic RPR in the DIMS group but not in the SV group. In conclusion, the baseline RPR profile may not influence future myopia progression or axial elongation for the SV lens wearers. However, DIMS lenses slowed down myopia progression and was better in myopia control for the children with baseline hyperopic RPR than the children with myopic RPR. This may partially explain why myopia control effects vary among myopic children. Customised myopic defocus for individuals may optimise myopia control effects, and further research to determine the optimal dosage, with consideration of peripheral retinal profile, is warranted.

Project description:ImportanceReducing myopia progression can reduce the risk of associated ocular pathologies.ObjectiveTo evaluate whether spectacle lenses with higher lenslet asphericity have a higher myopia control efficacy throughout 2 years.Design, setting, and participantsThis double-masked randomized clinical trial was conducted between July 2018 and October 2020 at the Eye Hospital of Wenzhou Medical University in Wenzhou, China. Children aged 8 to 13 years with a cycloplegic spherical equivalent refraction (SER) of -0.75 D to -4.75 D and astigmatism with less than -1.50 D were recruited. A data and safety monitoring committee reviewed findings from a planned interim analysis in 2019.InterventionsParticipants were randomly assigned in a 1:1:1 ratio to receive spectacle lenses with highly aspherical lenslets (HAL), spectacle lenses with slightly aspherical lenslets (SAL), or single-vision spectacle lenses (SVL).Main outcome and measuresTwo-year changes in SER and axial length and their differences between groups.ResultsOf 157 participants who completed each visit (mean [SD] age, 10.4 [1.2] years), 54 were analyzed in the HAL group, 53 in the SAL group, and 50 in the SVL group. Mean (SE) 2-year myopia progression in the SVL group was 1.46 (0.09) D. Compared with SVL, the mean (SE) change in SER was less for HAL (by 0.80 [0.11] D) and SAL (by 0.42 [0.11] D; P ≤ .001). The mean (SE) increase in axial length was 0.69 (0.04) mm for SVL. Compared with SVL, increase in axial length was slowed by a mean (SE) of 0.35 (0.05) mm for HAL and 0.18 (0.05) mm for SAL (P ≤ .001). Compared with SVL, for children who wore HAL at least 12 hours every day, the mean (SE) change in SER was slowed by 0.99 (0.12) D, and increase in axial length slowed by 0.41 (0.05) mm.Conclusions and relevanceIn this study, HAL and SAL reduced the rate of myopia progression and axial elongation throughout 2 years, with higher efficacy for HAL. Longer wearing hours resulted in better myopia control efficacy for HAL.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR1800017683.

Project description:BackgroundMyopia is increasing in prevalence and is currently recognized as a significant public health issue worldwide, particularly in China. Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, several publications indicate that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trials have compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses: defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition lenses (PALs).MethodsThe trial is designed as a 3-year, prospective, randomized, multicenter clinical trial of schoolchildren treated with DIMS lenses and PALs. A total of 600 Chinese primary school children aged 6-12 years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between - 1.00 and - 5.00 diopters and astigmatism ≤ 1.50 diopters. The follow-up time points will be 1 month (m), 3 m, 6 m, 12 m, 18 m, 24 m, 30 m, and 36 m. The primary outcome will be determined by the difference between the two groups in cycloplegic spherical equivalent refraction between baseline and the last follow-up visit. The secondary outcome is the axial length, and the exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, accommodation, compliance, and the results of questionnaires related to wearing experiences.DiscussionThe present study will be the first randomized controlled trial in myopic primary school children treated with DIMS lenses and PALs in China. The results will indicate whether and how much different MD mechanisms retard myopia progression and axial elongation. In addition, the comparison will provide information on the clinical efficacy and safety of DIMS lenses and PALs, including information related to wearing experiences and visual function.Trial registrationChinese Clinical Trial Registry (ChiCTR), ChiCTR1900025645. Registered on 3 September 2019. http://www.chictr.org.cn/showproj.aspx?proj=42927.

Project description:BackgroundMyopia control interventions, such as defocus incorporated multiple segments (DIMS) spectacle lenses, have been adopted in school-aged children to reduce the prevalence of myopia and its complications. This study aimed to investigate the effect of DIMS spectacle lenses on subfoveal choroidal thickness (SfChT) over a period of two years, as the choroidal response to myopic control is a crucial factor in exploring its potential effect on predicting myopia progression.MethodsThis study involved a secondary analysis of our previous randomized clinical trial. Myopic school-aged children aged 8-13 years were recruited in a two-year study investigating the effect of DIMS spectacle lenses on myopia progression. The treated group received DIMS spectacle lenses (n = 78), while the control group was treated with a pair of single vision (SV) spectacle lenses (n = 80). SfChT was monitored at 1 week, 1, 3, 6, 12, 18 and 24 months post lens wear using spectral-domain optical coherence tomography and a custom made auto-segmentation algorithm utilizing convolutional neural networks.ResultsSfChT increased significantly after one week of DIMS spectacle lens wear compared to those wearing SV spectacle lenses (adjusted mean change relative to baseline ± SEM at one week; DIMS vs. SV, 6.75 ± 1.52 µm vs. - 3.17 ± 1.48 µm; P < 0.0001, general linear model). The thickness of choroid increased to 13.64 ± 2.62 µm after 12 months of DIMS lens wear while the choroid thinned in SV group (- 9.46 ± 2.55 µm). Choroidal changes demonstrated a significant negative association with axial elongation over two years in both the DIMS and SV groups. Choroidal change at three months significantly predicted the changes in AL at 12 months after controlling the effect of age and gender.ConclusionsOur study demonstrated a significant choroidal thickening in response to myopic defocus incorporated in a spectacle lens after one week of lens wear, sustained over the two-year study period. The results suggested that choroidal changes at three months may help predict changes in axial length after one year. Trial registration ClinicalTrials.gov. Myopia control with the multi-segment lens. NCT02206217. Registered 29 July 2014, https://clinicaltrials.gov/ct2/show/study/NCT02206217.

Dataset Information

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

Publications

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

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