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Multicenter Study
. 2022 Mar 1;99(3):204-212.
doi: 10.1097/OPX.0000000000001873.

Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial

Paul Chamberlain, Arthur Bradley  1 , Baskar Arumugam  1 , David Hammond  1 , John McNally  1 , Nicola S Logan  2 , Deborah Jones  3 , Cheryl Ngo  4 , Sofia C Peixoto-de-Matos  5 , Chris Hunt  6 , Graeme Young  6
Affiliations
Multicenter Study

Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial

Paul Chamberlain et al. Optom Vis Sci. .

Abstract

Significance: Treatment of myopic children with a dual-focus soft contact lens (DFCL; MiSight 1 day) produced sustained slowing of myopia progression over a 6-year period. Significant slowing was also observed in children switched from a single vision control to treatment lenses (3 years in each lens).

Purpose: This study aimed to evaluate the effectiveness of DFCLs in sustaining slowed progression of juvenile-onset myopia over a 6-year treatment period and assess myopia progression in children who were switched to a DFCL at the end of year 3.

Methods: Part 1 was a 3-year clinical trial comparing DFCLs with a control contact lens (Proclear 1 day) at four investigational sites. In part 2, subjects completing part 1 were invited to continue for 3 additional years during which all children were treated with MiSight 1 day DFCLs (52 and 56 from the initially treated [T6] and control [T3] groups, respectively). Eighty-five subjects (45 [T3] and 40 [T6]) completed part 2. Cyclopleged spherical equivalent refractive errors (SEREs) and axial lengths (ALs) were monitored, and a linear mixed model was used to compare their adjusted change annually.

Results: Average ages at part 2 baseline were 13.2 ± 1.3 and 13.0 ± 1.5 years for the T6 and T3 groups, respectively. Slowed myopia progression in the T6 group observed during part 1 was sustained throughout part 2 (mean ± standard error of the mean: change from baseline SERE [in diopters], -0.52 ± 0.076 vs. -0.51 ± 0.076; change in AL [in millimeters], 0.28 ± 0.033 vs. 0.23 ± 0.033; both P > .05). Comparing progression rates in part 2 for the T6 and T3 groups, respectively, indicates that prior treatment does not influence efficacy (SERE, -0.51 ± 0.076 vs. -0.34 ± 0.077; AL, 0.23 ± 0.03 vs. 0.18 ± 0.03; both P > .05). Within-eye comparisons of AL growth revealed a 71% slowing for the T3 group (3 years older than part 1) and further revealed a small subset of eyes (10%) that did not respond to treatment.

Conclusions: Dual-focus soft contact lenses continue to slow the progression of myopia in children over a 6-year period revealing an accumulation of treatment effect. Eye growth of the initial control cohort with DFCL was slowed by 71% over the subsequent 3-year treatment period.

Trial registration: ClinicalTrials.gov NCT01729208.

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Conflict of interest statement

Conflict of Interest Disclosure: PC, AB, BA, DH, and JM are employees of the sponsor. The sponsor participated in study design, analysis, and interpretation. The authors were responsible for the preparation of this article and the decision to submit this article for publication. The contract research organization had full access to the study data; the investigators had partial access to the study data and take full responsibility for their presentation in this article. The lead author affirms that the article is an honest, accurate, and transparent account of the study being reported and that no important aspects of the study have been omitted. All investigators were independent from the study sponsor and take responsibility for the integrity of the data. All additional authors have critically reviewed the article for important intellectual content.

References

    1. Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology 2016;123:1036–42.
    1. Flitcroft DI, He M, Jonas JB, et al. IMI—Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiologic Studies. Invest Ophthalmol Vis Sci 2019;60:M20–30.
    1. Tideman JW, Snabel MC, Tedja MS, et al. Association of Axial Length with Risk of Uncorrectable Visual Impairment for Europeans with Myopia. JAMA Ophthalmol 2016;134:1355–63.
    1. Flitcroft DI. The Complex Interactions of Retinal, Optical and Environmental Factors in Myopia Aetiology. Prog Retin Eye Res 2012;31:622–60.
    1. Klaver CC, Wolfs RC, Vingerling JR, et al. Age-specific Prevalence and Causes of Blindness and Visual Impairment in an Older Population: The Rotterdam Study. Arch Ophthalmol 1998;116:653–8.

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