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

NCT ID: NCT04763694

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-12-05

Brief Summary

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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

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Conditions

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Myopia Accommodation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Subjects wore multifocal soft contact lenses for 12 months.

Group Type EXPERIMENTAL

Multifocal soft contact lenses

Intervention Type DEVICE

Myopic subjects wore multifocal soft contact lenses for 12 months

Interventions

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Multifocal soft contact lenses

Myopic subjects wore multifocal soft contact lenses for 12 months

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York College of Optometry

OTHER

Sponsor Role lead

Responsible Party

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Xiaoying Zhu

Assistant Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stewart Bloomfield, PhD

Role: STUDY_DIRECTOR

State University of New York College of Optometry

Locations

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State University of New York

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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IRBNET ID 1325316

Identifier Type: -

Identifier Source: org_study_id

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