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Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):1011-1021. doi: 10.1007/s00417-018-3906-z. Epub 2018 Feb 3.

MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial.

Author information

1
Department of Pharmacy, Biotechnology, Optics and Optometry, European University of Madrid, C/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. alicia.ruiz@universidadeuropea.es.
2
Department of Statistics, Mathematics and Informatics. Area of Languages and Computer Systems, Miguel Hernández University of Elche, Elche, Alicante, Spain.
3
Clínica oftalmológica Novovision, Madrid, Spain.
4
Department Optics I: Optometry and Vision, Universidad Complutense de Madrid, Madrid, Spain.
5
Doctoral and Research School, European University of Madrid, Madrid, Spain.

Abstract

PURPOSE:

To compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period.

METHODS:

Subjects aged 8 to 12 with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were assigned to the lens study group (MiSight) or the control group (single vision). Measurements of visual acuity and subjective refraction were taken at 6-month intervals, and axial length, anterior chamber, corneal power, and cycloplegic autorefraction were measured at the baseline, 12-month, and 24-month visits.

RESULTS:

Eighty-nine subjects were recruited. Forty-fix children were assigned to the MiSight group, and 33 to the single-vision spectacle group. In total, 74 children completed the clinical trial, with the following parameters at the beginning of the study: n =  41 in the MiSight group (age: 11.01 ± 1.23 years, spherical equivalent: -2.16 ± 0.94 D, gender: male: 21, female: 20) and n = 33 in the single-vision group (age: 10.12 ± 1.38 years, spherical equivalent: -1.75 ± 0.94 D, gender: male: 12, female: 21). After 2 years of follow-up, myopia progressed slowly in the MiSight group compared to the control group (0.45 D vs 0.74 D, p < 0.001) and there was less axial elongation in the MiSight group compared to the single-vision group (0.28 mm vs 0.44 mm, p < 0.001). Therefore, use of MiSight CLs produced lower myopia progression (39.32%) and lower axial growth of the eye (36.04%) at 2 years compared to spectacle use.

CONCLUSIONS:

MiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children. ClinicalTrials.gov Identifier: NCT01917110.

KEYWORDS:

Axial length; Children; Contact lenses; MiSight; Myopia

PMID:
29396662
DOI:
10.1007/s00417-018-3906-z
[Indexed for MEDLINE]

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