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OpenTrials
Completed

NCT Number: NCT04763694

Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control

The purpose of this study is to report the changes in accommodation, aberrations, and myopia in patients wearing multifocal soft contact lens for various durations.

The study objectives are to:

1. Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period. 2. Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.

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Key information

Conditions

Myopia Accommodation Eye Diseases Refractive Errors

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University of New York

New York, 10036, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 8-17 years
  • Refractive error: Sphere ≤ -10.00D, Cylinder ≤ 1.00D
  • Monocular BCVA 20/25 or better
  • No previous CL experience required

Exclusion criteria

  • History of ocular pathology, binocular vision anomalies, refractive surgery, previous myopia control therapy, pharmaceutical agent known to affect accommodation.

Treatment and study plan

Multifocal soft contact lenses

Device

Myopic subjects wore multifocal soft contact lenses for 12 months

Primary outcomes

  1. Axial length

    Time frame: 12 months

    Change in axial length over the duration of the study

  2. Refractive error

    Time frame: 12 months

    Change in refractive error over the duration of the study

  3. Accommodation

    Time frame: 12 months

    Accommodation at various distances during the study

Secondary outcomes

  1. Phoria

    Time frame: 12 months

    The amount of horizontal phoria (in prism diopter) at near while the subjects wore multifocal soft contact lenses, measured using Modified Thorington

Sponsors and collaborators

Lead sponsor

State University of New York College of Optometry

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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