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Binocular and accommodative function in the controlled randomized clinical trial MiSight® Assessment Study Spain (MASS)

  • Alicia Ruiz-PomedaEmail author
  • Belén Pérez-Sánchez
  • Pilar Cañadas
  • Francisco Luis Prieto-Garrido
  • Ramón Gutiérrez-Ortega
  • César Villa-Collar
Pediatrics
  • 101 Downloads

Abstract

Purpose

To evaluate the binocular and accommodative function in children wearing dual focus (DF) MiSight® contact lenses (CLs) for myopia control compared with children wearing single-vision (SV) spectacles.

Methods

This was a randomized, controlled clinical trial involving subjects aged 8 to 12, with myopia ranging from − 0.75 to − 4.00D and astigmatism < 1.00D, allocated to MiSight® study CLs group or control group wearing SV. Binocular and accommodative function was determined at baseline, 12-, and 24-month visits, assessed by the following sequence of tests: distance and near horizontal phoria, accommodative convergence/accommodation (AC/A) ratio, stereopsis, accommodative amplitude (AA), and accommodative response (AR) at 33, 25 and 20 cm.

Results

Seventy-four children completed the study: 41 in the CL group and 33 in the SV group. CLs group did not show any significant differences in binocular and accommodative measurements throughout the study. In control group, distance and near phoria, stereopsis, AC/A and AR at 20 cm did not show any significant change, but AA, AR at 33 cm and AR at 25 cm were greater at 24-month visit compared with baseline (p < 0.05).

Conclusions

DF lenses do not change the binocular and accommodative function in children wearing dual focus CLs.

Trial registration

NCT01917110

Keywords

Binocular vision Accommodation Dual focus contact lenses Children 

Notes

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.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

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.

Informed consent

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

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Alicia Ruiz-Pomeda
    • 1
    Email author return OK on get
  • Belén Pérez-Sánchez
    • 2
  • Pilar Cañadas
    • 3
  • Francisco Luis Prieto-Garrido
    • 4
  • Ramón Gutiérrez-Ortega
    • 5
  • César Villa-Collar
    • 1
  1. 1.Faculty of Biomedical and Health Sciences, Department of Pharmacy, Biotechnology, Nutrition, Optics and OptometryEuropean University of MadridMadridSpain
  2. 2.Department of Statistics, Mathematics and Informatics, Area of Languages and Computer SystemsMiguel Hernández University of ElcheAlacantSpain
  3. 3.Ocular Surface Group. Institute of Applicate Opthalmobiology (IOBA), Department of Theoretical Physics, Atomic and OpticUniversity of ValladolidValladolidSpain
  4. 4.Department Optics I: Optometry and VisionUniversidad Complutense de MadridMadridSpain
  5. 5.Clínica oftalmológica NovovisiónMadridSpain

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