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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Accommodation
• Myopia

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