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

  • Pediatrics
  • Published:
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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.

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Acknowledgments

The authors would like to thank Peter Bonney for proofreading the article.

Funding

CooperVision S.L. Spain provided financial support. CooperVision S.L. provided the study contact lenses and the funding to carry out the clinical trial.

The sponsor had no role in the design or conduct of this research.

Author information

Authors and Affiliations

  1. Department of Pharmacy, Biotechnology, Optics and Optometry, European University of Madrid, C/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain

    Alicia Ruiz-Pomeda

  2. Department of Statistics, Mathematics and Informatics. Area of Languages and Computer Systems, Miguel Hernández University of Elche, Elche, Alicante, Spain

    Belén Pérez-Sánchez

  3. Clínica oftalmológica Novovision, Madrid, Spain

    Isabel Valls & Ramón Gutiérrez-Ortega

  4. Department Optics I: Optometry and Vision, Universidad Complutense de Madrid, Madrid, Spain

    Francisco Luis Prieto-Garrido

  5. Doctoral and Research School, European University of Madrid, Madrid, Spain

    César Villa-Collar

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  1. Alicia Ruiz-Pomeda
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  2. Belén Pérez-Sánchez
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  3. Isabel Valls
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  4. Francisco Luis Prieto-Garrido
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Correspondence to Alicia Ruiz-Pomeda.

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Conflict of interest

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (CEI-R, Regional Research Ethics Committee of the Community of Madrid, Spain) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Ruiz-Pomeda, A., Pérez-Sánchez, B., Valls, I. et al. MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial. Graefes Arch Clin Exp Ophthalmol 256, 1011–1021 (2018). https://doi.org/10.1007/s00417-018-3906-z

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  • DOI: https://doi.org/10.1007/s00417-018-3906-z

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