Dynamic Change in Accommodation After Wearing Multifocal... | NCT04763694

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

NCT04763694

Sponsor

State University of New York College of Optometry

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Myopia
Accommodation

Interventions

Multifocal soft contact lenses

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Dec 5, 2020Actual

Completion Date

Dec 5, 2020Actual

First Submitted Date

Feb 11, 2021

First Submission Date that Met QC Criteria

Feb 18, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaoying Zhu, Assistant Clinical Professor, State University of New York College of OptometryPrincipal Investigator

Lead Sponsor

State University of New York College of OptometryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental	Subjects wore multifocal soft contact lenses for 12 months.	Device: Multifocal soft contact lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multifocal soft contact lenses	Device	Myopic subjects wore multifocal soft contact lenses for 12 months	Treatment arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stewart Bloomfield, PhD	State University of New York College of Optometry	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State University of New York		New York	New York	10036	United States

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided