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NCT04763694 Clinical Trial

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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04763694
Other study ID # IRBNET ID 1325316
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date December 5, 2020

Study information
Verified date February 2021
Source State University of New York College of Optometry
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 5, 2020
Est. primary completion date December 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Multifocal soft contact lenses
Myopic subjects wore multifocal soft contact lenses for 12 months

Locations
Country Name City State
United States State University of New York New York New York

Sponsors (1)
Lead Sponsor Collaborator
State University of New York College of Optometry

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Axial length Change in axial length over the duration of the study 12 months
Primary Refractive error Change in refractive error over the duration of the study 12 months
Primary Accommodation Accommodation at various distances during the study 12 months
Secondary Phoria The amount of horizontal phoria (in prism diopter) at near while the subjects wore multifocal soft contact lenses, measured using Modified Thorington 12 months
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