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

Graefe's Archive for Clinical and Experimental Ophthalmology volume 257, pages 207–215 (2019)Cite this article

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

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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. Faculty of Biomedical and Health Sciences, Department of Pharmacy, Biotechnology, Nutrition, Optics and Optometry, European University of Madrid, C/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain

    Alicia Ruiz-Pomeda & César Villa-Collar

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

    Belén Pérez-Sánchez

  3. Ocular Surface Group. Institute of Applicate Opthalmobiology (IOBA), Department of Theoretical Physics, Atomic and Optic, University of Valladolid, Valladolid, Spain

    Pilar Cañadas

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

    Francisco Luis Prieto-Garrido

  5. Clínica oftalmológica Novovisión, Madrid, Spain

    Ramón Gutiérrez-Ortega

Authors
  1. Alicia Ruiz-Pomeda
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  2. Belén Pérez-Sánchez
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  3. Pilar Cañadas
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  4. Francisco Luis Prieto-Garrido
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  5. Ramón Gutiérrez-Ortega
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  6. César Villa-Collar
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Corresponding author

Correspondence to Alicia Ruiz-Pomeda.

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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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Ruiz-Pomeda, A., Pérez-Sánchez, B., Cañadas, P. et al. Binocular and accommodative function in the controlled randomized clinical trial MiSight® Assessment Study Spain (MASS). Graefes Arch Clin Exp Ophthalmol 257, 207–215 (2019). https://doi.org/10.1007/s00417-018-4115-5

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  • DOI: https://doi.org/10.1007/s00417-018-4115-5

Keywords

  • Binocular vision
  • Accommodation
  • Dual focus contact lenses
  • Children