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.

Study Overview

• Status: Completed
• Conditions: Myopia; Accommodation
• Intervention / Treatment: Device: Multifocal soft contact lenses

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10036
      • State University of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Subjects wore multifocal soft contact lenses for 12 months.	Device: Multifocal soft contact lenses; Myopic subjects wore multifocal soft contact lenses for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Change in axial length over the duration of the study	12 months
Refractive error	Change in refractive error over the duration of the study	12 months
Accommodation	Accommodation at various distances during the study	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: State University of New York College of Optometry
• Investigators: Study Director: Stewart Bloomfield, PhD, State University of New York College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 5, 2020
• Study Completion (Actual): December 5, 2020

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: IRBNET ID 1325316

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes