Dataset Information

Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses.

ABSTRACT: To determine the effect of progressive addition lenses (PALs) and single vision lenses (SVLs) on peripheral defocus in myopic children, and to compare the effect of myopic versus hyperopic peripheral defocus on foveal myopia progression.Eighty-four myopic children aged 6 to 11 years with spherical equivalent (SE) cycloplegic autorefraction between -0.75 diopters (D) and -4.50 D were randomly assigned to wear SVLs or PALs. Aberrometry measurements of the eye and spectacles were made centrally, 30° nasally, temporally, and superiorly, and 20° inferiorly on the retina using a Complete Ophthalmic Analysis System for Vision Research (COAS-VR). The association between peripheral defocus and the 1-year change in central myopia was investigated.SVLs caused a hyperopic shift in peripheral defocus at all locations (all P ? 0.0003). PALs caused a myopic shift in peripheral defocus in three of four locations measured (all P ? 0.01) with the greatest shift superiorly due to the PAL addition (-1.04 ± 0.30 D). Superior retinal defocus when wearing either SVLs or PALs was associated with the 1-year change in central myopia. The adjusted 1-year change in central SE myopia was -0.38 D for children with absolute superior myopic defocus (n = 67) and -0.65 D for children with absolute superior hyperopic defocus (n = 17; difference = 0.27 D; P = 0.002).PALs caused a myopic shift in peripheral defocus. Superior myopic defocus was associated with less central myopia progression. These data support the continued investigation of optical designs that result in peripheral myopic defocus as a potential way to slow myopia progression. (ClinicalTrials.gov number, NCT00335049.).

SUBMITTER: Berntsen DA

PROVIDER: S-EPMC3755539 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses.

Berntsen David A DA Barr Christopher D CD Mutti Donald O DO Zadnik Karla K

Investigative ophthalmology & visual science 20130827 8

<h4>Purpose</h4>To determine the effect of progressive addition lenses (PALs) and single vision lenses (SVLs) on peripheral defocus in myopic children, and to compare the effect of myopic versus hyperopic peripheral defocus on foveal myopia progression.<h4>Methods</h4>Eighty-four myopic children aged 6 to 11 years with spherical equivalent (SE) cycloplegic autorefraction between -0.75 diopters (D) and -4.50 D were randomly assigned to wear SVLs or PALs. Aberrometry measurements of the eye and sp ...[more]

PMID: 23838771

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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: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: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:SIGNIFICANCE:Growing popularity of handheld digital devices imposes significant challenges to our visual system and clinical management. This study aimed to determine the effects of lens design on parameters that may influence the refractive management of pre-presbyopic adult computer users. PURPOSE:To determine the effects of wearing conventional single-vision lenses (SVL) versus progressive addition lenses (PAL) on the working distance and refractive status. METHODS:Adult computer users, recruited from two age cohorts (18 to 25 years, n = 19; 30 to 40 years, n = 45), were prescribed SVLs and PALs designed for use with handheld digital devices. For each lens type, the working distance and refractive shift (post-task - pre-task) were measured immediately after lens delivery (T0) and after 1 month of lens wear (T1). Working distances were recorded with an automatic ultrasound device while the participants were playing a video game. Refractive status through the subjects' glasses was measured before (pre-task) and after playing the game (post-task). Questionnaires assessing the frequencies of 10 digital work-related visual symptoms were conducted for both lens types at T1. RESULTS:Switching from SVL to PAL increased the working distance in both cohorts (mean ± SEM = 1.88 ± 0.60 cm; P = .002) and induced a small but significant positive refractive shift (+0.08 ± 0.04 D, P = .021) in the older cohort at T1. In the younger cohort, the changes in working distance due to the switching lens design were correlated with myopic error (r = +0.66, P = .002). In the older cohort, the changes in refractive shift due to switching lens design were correlated with amplitude of accommodation at both time points (r for T0 and T1 = -0.32 and -0.30, respectively; both P < .05). Progressive addition lens was rated as causing less "increased sensitivity to light" compared with SVL. CONCLUSIONS:Switching from SVL to PAL increased the working distance and induced a positive refractive shift in the majority of pre-presbyopic adults.

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Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses.

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Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses.

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