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...
Main Authors: | , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2022-08-01
|
Series: | BMC Ophthalmology |
Subjects: | |
Online Access: | https://doi.org/10.1186/s12886-022-02562-0 |
_version_ | 1798038849639677952 |
---|---|
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. |
first_indexed | 2024-04-11T21:45:59Z |
format | Article |
id | doaj.art-8482e87f33d448538b2cafd4070648cf |
institution | Directory Open Access Journal |
issn | 1471-2415 |
language | English |
last_indexed | 2024-04-11T21:45:59Z |
publishDate | 2022-08-01 |
publisher | BMC |
record_format | Article |
series | BMC Ophthalmology |
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 |
work_keys_str_mv | AT junhongchen spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT ranzhuo spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT jiayanchen spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT adelineyang spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT eewoonlim spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT jinhuabao spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT bjorndrobe spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT danielpspiegel spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT haochen spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata AT lijiehou spectaclelenseswithslightlyasphericallensletsformyopiacontrolclinicaltrialdesignandbaselinedata |