• Graefes Arch. Clin. Exp. Ophthalmol. · May 2018

    Randomized Controlled Trial Comparative Study

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

    • Alicia Ruiz-Pomeda, Belén Pérez-Sánchez, Isabel Valls, Francisco Luis Prieto-Garrido, Ramón Gutiérrez-Ortega, and César Villa-Collar.
    • 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.
    • Graefes Arch. Clin. Exp. Ophthalmol. 2018 May 1; 256 (5): 1011-1021.

    PurposeTo compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period.MethodsSubjects 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.ResultsEighty-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.ConclusionsMiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children. ClinicalTrials.gov Identifier: NCT01917110.

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