Dataset Information

Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial.

ABSTRACT:

Importance

Reducing myopia progression can reduce the risk of associated ocular pathologies.

Objective

To evaluate whether spectacle lenses with higher lenslet asphericity have a higher myopia control efficacy throughout 2 years.

Design, setting, and participants

This 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.

Interventions

Participants 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 measures

Two-year changes in SER and axial length and their differences between groups.

Results

Of 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 relevance

In 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 registration

Chinese Clinical Trial Registry Identifier: ChiCTR1800017683.

SUBMITTER: Bao J

PROVIDER: S-EPMC8972151 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial.

Bao Jinhua J Huang Yingying Y Li Xue X Yang Adeline A Zhou Fengchao F Wu Junqian J Wang Chu C Li Yuhao Y Lim Ee Woon EW Spiegel Daniel P DP Drobe Björn B Chen Hao H

JAMA ophthalmology 20220501 5

<h4>Importance</h4>Reducing myopia progression can reduce the risk of associated ocular pathologies.<h4>Objective</h4>To evaluate whether spectacle lenses with higher lenslet asphericity have a higher myopia control efficacy throughout 2 years.<h4>Design, setting, and participants</h4>This 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 sphe ...[more]

PMID: 35357402

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Project description:ObjectivesTo investigate the short- and long-term effects of myopia control spectacle lenses with highly aspherical lenslets (HAL) and slightly aspherical lenslets (SAL) on visual function and visual quality using data obtained from a randomized controlled clinical trial.MethodsThis was a prospective, randomized, controlled, and double-blinded study; 170 myopic children aged 8-13 years were randomly assigned to the HAL, SAL, or single-vision spectacle lenses (SVL) groups. Distance and near visual acuity (VA) at high (100%) and low (10%) contrast in photopic and scotopic conditions, near phoria, stereoacuity, and accommodative lag, microfluctuations (AMFs), amplitude (AA) were measured after wearing lenses for 10 min, 6 months, and 12 months.ResultsIn total, 161 subjects completed all follow-up in 12 months and were included in the analysis. After 10 min of wearing, the HAL and SAL groups had lower scotopic and low-contrast VA than the SVL group (decreased 0.03-0.08 logMAR and 0.01-0.04 logMAR in different VAs in the HAL and SAL groups, respectively, all P < 0.05). The reduction in VA was recovered at 12 months as the HAL and SAL groups exhibited significant VA improvements, and the VA was not different among the three groups (all P > 0.05). The HAL and SAL groups had significantly larger AMFs than the SVL group (HAL vs. SAL vs. SVL: 0.21 ± 0.08 D vs. 0.16 ± 0.05 D vs. 0.15 ± 0.06 D at baseline, 0.19 ± 0.07 D vs. 0.17 ± 0.05 D vs. 0.13 ± 0.07 D at 12 months, all P < 0.05). There were no significant differences in accommodative lag, AA, or phoria between the groups (all P > 0.05). The HAL and SAL groups had reduced stereoacuity compared to the SVL group at baseline (70' vs. 60' vs. 50', P = 0.005), but no difference was observed at 12 months (70' vs. 70' vs. 70', P = 0.11).ConclusionsHAL and SAL have no significant influence on accommodation and phoria except had larger AMF than SVL. Scotopic VA and low-contrast VA are reduced with short-term HAL and SAL use but recovered to be at same level with the SVL after 1 year of use. Trial registration Chinese Clinical Trial Registry: ChiCTR1800017683. Registered on 9 August 2018. http://www.chictr.org.cn/showproj.aspx?proj=29789.

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: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.

Dataset Information

Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcome and measures

Results

Conclusions and relevance

Trial registration

Publications

Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial.

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