NCT04763694

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. 1.Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period.
  2. 2.Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

February 11, 2021

Last Update Submit

February 18, 2021

Conditions

MyopiaAccommodation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Phoria

    12 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Subjects wore multifocal soft contact lenses for 12 months.

Device: Multifocal soft contact lenses

Interventions

Multifocal soft contact lensesDEVICE

Myopic subjects wore multifocal soft contact lenses for 12 months

Treatment arm

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: 8-17 years
  • Refractive error: Sphere ≤ -10.00D, Cylinder ≤ 1.00D
  • Monocular BCVA 20/25 or better
  • No previous CL experience required

You may not qualify if:

  • History of ocular pathology, binocular vision anomalies, refractive surgery, previous myopia control therapy, pharmaceutical agent known to affect accommodation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Stewart Bloomfield, PhD

    State University of New York College of Optometry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 21, 2021

Study Start

October 1, 2018

Primary Completion

December 5, 2020

Study Completion

December 5, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(1)