Back to resultsDynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
Primary Purpose
Myopia, Accommodation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multifocal soft contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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.
Sites / Locations
- State University of New York
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
Subjects wore multifocal soft contact lenses for 12 months.
Outcomes
Primary Outcome Measures
Axial length
Change in axial length over the duration of the study
Refractive error
Change in refractive error over the duration of the study
Accommodation
Accommodation at various distances during the study
Secondary Outcome Measures
Phoria
The amount of horizontal phoria (in prism diopter) at near while the subjects wore multifocal soft contact lenses, measured using Modified Thorington
Full Information
NCT ID
NCT04763694
First Posted
February 11, 2021
Last Updated
February 18, 2021
Sponsor
State University of New York College of Optometry
1. Study Identification
Unique Protocol Identification Number
NCT04763694
Brief Title
Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
Official Title
Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 5, 2020 (Actual)
Study Completion Date
December 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York College of Optometry
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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:
Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period.
Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Accommodation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Subjects wore multifocal soft contact lenses for 12 months.
Intervention Type
Device
Intervention Name(s)
Multifocal soft contact lenses
Intervention Description
Myopic subjects wore multifocal soft contact lenses for 12 months
Primary Outcome Measure Information:
Title
Axial length
Description
Change in axial length over the duration of the study
Time Frame
12 months
Title
Refractive error
Description
Change in refractive error over the duration of the study
Time Frame
12 months
Title
Accommodation
Description
Accommodation at various distances during the study
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Phoria
Description
The amount of horizontal phoria (in prism diopter) at near while the subjects wore multifocal soft contact lenses, measured using Modified Thorington
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stewart Bloomfield, PhD
Organizational Affiliation
State University of New York College of Optometry
Official's Role
Study Director
Facility Information:
Facility Name
State University of New York
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
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