Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data

Abstract Objectives Myopia is a major public health problem and it is essential to find safe and effective means to control its progression. The study design and baseline data are presented for a one-year prospective, double-masked, crossover, randomized clinical trial evaluating the efficacy of sin...

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Main Authors: Junhong Chen, Ran Zhuo, Jiayan Chen, Adeline Yang, Ee Woon Lim, Jinhua Bao, Björn Drobe, Daniel P. Spiegel, Hao Chen, Lijie Hou
Format: Article
Language:English
Published: BMC 2022-08-01
Series:BMC Ophthalmology
Subjects:
Online Access:https://doi.org/10.1186/s12886-022-02562-0
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author Junhong Chen
Ran Zhuo
Jiayan Chen
Adeline Yang
Ee Woon Lim
Jinhua Bao
Björn Drobe
Daniel P. Spiegel
Hao Chen
Lijie Hou
author_facet Junhong Chen
Ran Zhuo
Jiayan Chen
Adeline Yang
Ee Woon Lim
Jinhua Bao
Björn Drobe
Daniel P. Spiegel
Hao Chen
Lijie Hou
author_sort Junhong Chen
collection DOAJ
description Abstract Objectives Myopia is a major public health problem and it is essential to find safe and effective means to control its progression. The study design and baseline data are presented for a one-year prospective, double-masked, crossover, randomized clinical trial evaluating the efficacy of single vision spectacle lenses with concentric rings of slightly aspherical contiguous lenslets technology (SAL) on myopia control. Methods One hundred 8- to 13-year old Chinese children with a refractive error of -0.75 D to -4.75 D were assigned to two groups. In Group 1, SAL and single vision lenses were each worn for 6 months, and Group 2 wore the lenses in the reversed order. Primary outcomes are axial length and spherical equivalent of cycloplegic refractive error. Secondary outcomes included corneal thickness, anterior chamber depth, lens thickness, visual acuity, and lens adaptation. Results No significant differences in baseline parameters (cycloplegic spherical equivalent, axial length, age) were found between groups (0.49 < p < 0.94). All children adapted well to the test lenses and there was no significant difference in visual acuity between the SAL and single vision lenses (p = 0.27). Conclusions The children in the two well balanced groups had comparable visual acuity and adapted well to the test lenses. These results imply that visual acuity can be well improved by SAL lenses. Clear visual acuity provides the assurance for good compliance in this longitudinal study.
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spelling doaj.art-8482e87f33d448538b2cafd4070648cf2022-12-22T04:01:25ZengBMCBMC Ophthalmology1471-24152022-08-0122111010.1186/s12886-022-02562-0Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline dataJunhong Chen0Ran Zhuo1Jiayan Chen2Adeline Yang3Ee Woon Lim4Jinhua Bao5Björn Drobe6Daniel P. Spiegel7Hao Chen8Lijie Hou9School of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical UniversitySchool of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical UniversityDepartment of Optometry Center, Affiliated Eye Hospital of Wenzhou Medical UniversityEssilor International Research Center (WEIRC), Wenzhou Medical UniversityEssilor International Research Center (WEIRC), Wenzhou Medical UniversitySchool of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical UniversityEssilor International Research Center (WEIRC), Wenzhou Medical UniversityEssilor International Research Center (WEIRC), Wenzhou Medical UniversitySchool of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical UniversityHangzhou Branch of Zhejiang Eye Hospital Affiliated to Wenzhou Medical UniversityAbstract Objectives Myopia is a major public health problem and it is essential to find safe and effective means to control its progression. The study design and baseline data are presented for a one-year prospective, double-masked, crossover, randomized clinical trial evaluating the efficacy of single vision spectacle lenses with concentric rings of slightly aspherical contiguous lenslets technology (SAL) on myopia control. Methods One hundred 8- to 13-year old Chinese children with a refractive error of -0.75 D to -4.75 D were assigned to two groups. In Group 1, SAL and single vision lenses were each worn for 6 months, and Group 2 wore the lenses in the reversed order. Primary outcomes are axial length and spherical equivalent of cycloplegic refractive error. Secondary outcomes included corneal thickness, anterior chamber depth, lens thickness, visual acuity, and lens adaptation. Results No significant differences in baseline parameters (cycloplegic spherical equivalent, axial length, age) were found between groups (0.49 < p < 0.94). All children adapted well to the test lenses and there was no significant difference in visual acuity between the SAL and single vision lenses (p = 0.27). Conclusions The children in the two well balanced groups had comparable visual acuity and adapted well to the test lenses. These results imply that visual acuity can be well improved by SAL lenses. Clear visual acuity provides the assurance for good compliance in this longitudinal study.https://doi.org/10.1186/s12886-022-02562-0MyopiaSpectacle lensesProspective studiesRefractive errorsAxial length
spellingShingle Junhong Chen
Ran Zhuo
Jiayan Chen
Adeline Yang
Ee Woon Lim
Jinhua Bao
Björn Drobe
Daniel P. Spiegel
Hao Chen
Lijie Hou
Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data
BMC Ophthalmology
Myopia
Spectacle lenses
Prospective studies
Refractive errors
Axial length
title Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data
title_full Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data
title_fullStr Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data
title_full_unstemmed Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data
title_short Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data
title_sort spectacle lenses with slightly aspherical lenslets for myopia control clinical trial design and baseline data
topic Myopia
Spectacle lenses
Prospective studies
Refractive errors
Axial length
url https://doi.org/10.1186/s12886-022-02562-0
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