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

Not Applicable

Completed

• Conditions: Myopia; Accommodation
• Interventions: Device: Multifocal soft contact lenses

• Registration Number: NCT04763694
• Lead Sponsor: State University of New York College of Optometry

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2020-12-05
• Study Completion: 2020-12-05
• Status Verified: 2021-02
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Multifocal soft contact lenses	Subjects wore multifocal soft contact lenses for 12 months.

Primary Outcome Measures

Name	Time	Method
Axial length	12 months	Change in axial length over the duration of the study
Refractive error	12 months	Change in refractive error over the duration of the study
Accommodation	12 months	Accommodation at various distances during the study

Secondary Outcome Measures

Name	Time	Method
Phoria	12 months	The amount of horizontal phoria (in prism diopter) at near while the subjects wore multifocal soft contact lenses, measured using Modified Thorington

Trial Locations

Locations (1)

State University of New York; 🇺🇸 New York, New York, United States