Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia Progression Among Taiwanese Schoolchildren: A Randomized Paired-Eye Clinical Trial

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Abstract

Introduction

To evaluate the efficacy and safety of myopia control using a multifocal soft contact lens designed with high peripheral add power in schoolchildren.

Methods

This 1-year multi-center, prospective, randomized, double-blind, controlled study enrolled myopic schoolchildren aged 6–15 years with refractive errors between − 1.0 D and − 10.0 D. Each participant was randomly allocated to wear a daily disposable multifocal soft contact lens as the treatment in one eye and a single-vision soft contact lens as the control in the other eye. The primary endpoints were changes in the cycloplegic spherical equivalent (SE) and axial length at 1 year.

Results

Fifty-two of the 59 participants (88.1%) completed the study protocol. The mean change in SE was − 0.73 ± 0.40 D in the treatment group. and − 0.85 ± 0.51 D in the control group (mean difference: − 0.12 ± 0.34 D, p = 0.012). The mean change in axial length was 0.25 ± 0.14 mm in the treatment group, and 0.33 ± 0.17 mm in the control group (mean difference: 0.08 ± 0.10 mm, p < 0.001). The treatment was well tolerated, and no serious adverse events were observed.

Conclusions

Treatment with multifocal soft contact lenses with high peripheral add power was effective in controlling the progression of myopia and axial length elongation in myopic schoolchildren.

Supplementary Information

The online version contains supplementary material available at 10.1007/s40123-023-00859-x.

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Most cited references 22

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Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050.

Brien A. Holden, Timothy Fricke, David Wilson … (2016)

Myopia is a common cause of vision loss, with uncorrected myopia the leading cause of distance vision impairment globally. Individual studies show variations in the prevalence of myopia and high myopia between regions and ethnic groups, and there continues to be uncertainty regarding increasing prevalence of myopia.

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The complex interactions of retinal, optical and environmental factors in myopia aetiology.

D.I. Flitcroft (2012)

Myopia is the commonest ocular abnormality but as a research topic remains at the margins of mainstream ophthalmology. The concept that most myopes fall into the category of 'physiological myopia' undoubtedly contributes to this position. Yet detailed analysis of epidemiological data linking myopia with a range of ocular pathologies from glaucoma to retinal detachment demonstrates statistically significant disease association in the 0 to -6 D range of 'physiological myopia'. The calculated risks from myopia are comparable to those between hypertension, smoking and cardiovascular disease. In the case of myopic maculopathy and retinal detachment the risks are an order of magnitude greater. This finding highlights the potential benefits of interventions that can limit or prevent myopia progression. Our understanding of the regulatory processes that guide an eye to emmetropia and, conversely how the failure of such mechanisms can lead to refractive errors, is certainly incomplete but has grown enormously in the last few decades. Animal studies, observational clinical studies and more recently randomized clinical trials have demonstrated that the retinal image can influence the eye's growth. To date human intervention trials in myopia progression using optical means have had limited success but have been designed on the basis of simple hypotheses regarding the amount of defocus at the fovea. Recent animal studies, backed by observational clinical studies, have revealed that the mechanisms of optically guided eye growth are influenced by the retinal image across a wide area of the retina and not solely the fovea. Such results necessitate a fundamental shift in how refractive errors are defined. In the context of understanding eye growth a single sphero-cylindrical definition of foveal refraction is insufficient. Instead refractive error must be considered across the curved surface of the retina. This carries the consequence that local retinal image defocus can only be determined once the 3D structure of the viewed scene, off axis performance of the eye and eye shape has been accurately defined. This, in turn, introduces an under-appreciated level of complexity and interaction between the environment, ocular optics and eye shape that needs to be considered when planning and interpreting the results of clinical trials on myopia prevention. Copyright © 2012 Elsevier Ltd. All rights reserved.

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The Complications of Myopia: A Review and Meta-Analysis

Annechien E. G. Haarman, Clair A. Enthoven, J. Willem L. Tideman … (2020)

Purpose To determine the risk between degree of myopia and myopic macular degeneration (MMD), retinal detachment (RD), cataract, open angle glaucoma (OAG), and blindness. Methods A systematic review and meta-analyses of studies published before June 2019 on myopia complications. Odds ratios (OR) per complication and spherical equivalent (SER) degree (low myopia SER –3.00 diopter [D]; moderate myopia SER ≤ –3.00 to > –6.00 D; high myopia SER ≤ –6.00 D) were calculated using fixed and random effects models. Results Low, moderate, and high myopia were all associated with increased risks of MMD (OR, 13.57, 95% confidence interval [CI], 6.18–29.79; OR, 72.74, 95% CI, 33.18–159.48; OR, 845.08, 95% CI, 230.05–3104.34, respectively); RD (OR, 3.15, 95% CI, 1.92–5.17; OR, 8.74, 95% CI, 7.28–10.50; OR, 12.62, 95% CI, 6.65–23.94, respectively); posterior subcapsular cataract (OR, 1.56, 95% CI, 1.32–1.84; OR, 2.55, 95% CI, 1.98–3.28; OR, 4.55, 95% CI, 2.66–7.75, respectively); nuclear cataract (OR, 1.79, 95% CI, 1.08–2.97; OR, 2.39, 95% CI, 1.03–5.55; OR, 2.87, 95% CI, 1.43–5.73, respectively); and OAG (OR, 1.59, 95% CI, 1.33–1.91; OR, 2.92, 95% CI, 1.89–4.52 for low and moderate/high myopia, respectively). The risk of visual impairment was strongly related to longer axial length, higher myopia degree, and age older than 60 years (OR, 1.71, 95% CI, 1.07–2.74; OR, 5.54, 95% CI, 3.12–9.85; and OR, 87.63, 95% CI, 34.50–222.58 for low, moderate, and high myopia in participants aged >60 years, respectively). Conclusions Although high myopia carries the highest risk of complications and visual impairment, low and moderate myopia also have considerable risks. These estimates should alert policy makers and health care professionals to make myopia a priority for prevention and treatment.

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Author and article information

Contributors

Tzu-Hsun Tsai:

ORCID: http://orcid.org/0000-0002-2320-4458

lucia_tsai@yahoo.com.tw , tsaith@ntuh.gov.tw

Journal

Journal ID (nlm-ta): Ophthalmol Ther

Journal ID (iso-abbrev): Ophthalmol Ther

Title: Ophthalmology and Therapy

Publisher: Springer Healthcare (Cheshire )

ISSN (Print): 2193-8245

ISSN (Electronic): 2193-6528

Publication date (Electronic): 21 December 2023

Publication date PMC-release: 21 December 2023

Publication date (Print): February 2024

Volume: 13

Issue: 2

Pages: 541-552

Affiliations

[1 ]GRID grid.19188.39, ISNI 0000 0004 0546 0241, Department of Ophthalmology, College of Medicine, , National Taiwan University Hospital, National Taiwan University, ; Taipei, Taiwan

[2 ]Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, ( https://ror.org/05bqach95) Taipei, Taiwan

[3 ]Department of Ophthalmology, Chang Gung Memorial Hospital Linkou Branches, ( https://ror.org/02verss31) Taoyüan, Taiwan

[4 ]Great Vision Eye Clinic, Taichung, Taiwan

[5 ]College of Biological Science and Technology, National Yang Ming Chiao Tung University, ( https://ror.org/00se2k293) Hsinchu, Taiwan

[6 ]Department of Ophthalmology, Chang Gung Memorial Hospital Taipei Branches, ( https://ror.org/02verss31) Taipei, Taiwan

[7 ]Department of Ophthalmology, National Taiwan University Hospital Hsin-Chu Branch, ( https://ror.org/03nteze27) Hsinchu, Taiwan

Author information

Yao-Lin Liu http://orcid.org/0000-0002-3149-458X

Ken-Kuo Lin http://orcid.org/0000-0003-1306-134X

Li-Sheng Cheng http://orcid.org/0009-0002-8163-6512

Chao-Wen Lin http://orcid.org/0000-0001-5766-3057

Jiahn-Shing Lee http://orcid.org/0000-0001-7007-939X

Chiun-Ho Hou http://orcid.org/0000-0003-2441-039X

Tzu-Hsun Tsai http://orcid.org/0000-0002-2320-4458

Article

Publisher ID: 859

DOI: 10.1007/s40123-023-00859-x

PMC ID: 10787710

PubMed ID: 38127196

SO-VID: 02291b62-5c5e-4a96-9584-7313e3f9df86

License:

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 16 October 2023

Date accepted : 21 November 2023

Funding

Funded by: Largan Medical Co., Ltd.

Custom metadata

Keywords: axial length,children,myopia control,multifocal soft contact lens,peripheral myopic defocus

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Keywords: axial length, children, myopia control, multifocal soft contact lens, peripheral myopic defocus

Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia Progression Among Taiwanese Schoolchildren: A Randomized Paired-Eye Clinical Trial

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Supplementary Information

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Most cited references 22

Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050.

The complex interactions of retinal, optical and environmental factors in myopia aetiology.

The Complications of Myopia: A Review and Meta-Analysis

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