Effects of Contact Lens Wear on Children's Self-Perceptions | NCT00522288

Studies
Effects of Contact Lens Wear on Children's Self-Perceptions

NCT00522288

Sponsor

Ohio State University

Status

Completed

Last Update Posted

Mar 21, 2011Estimated

Enrollment

484Actual

Phase

Not Applicable

Conditions

Myopia

Interventions

Soft contact lenses
Spectacle

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

Mar 2011

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

Sep 2003

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Aug 28, 2007

First Submission Date that Met QC Criteria

Aug 28, 2007

First Posted Date

Aug 29, 2007Estimated

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

Mar 17, 2011

Last Update Posted Date

Mar 21, 2011Estimated

Name	Class
Johnson & Johnson Vision Care, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.

Detailed Description

Eight to eleven year old children will be randomly assigned to wear spectacles or soft contact lenses. The children's self-perceptions will be measured at baseline and every six months. We will compare the change in self-perception between spectacle and soft contact lens wearers over three years. We will also examine the effect of how much children initially like or dislike to wear glasses on the change in self-perception over three years.

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

484Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Contact Lens	Experimental	Soft contact lenses	Device: Soft contact lenses
Spectacle	Active Comparator	Spectacles	Device: Spectacle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Soft contact lenses	Device	Daily wear soft contact lenses disposed of daily or biweekly	Contact Lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global Self-Worth Scale from the Self-Perception Profile for Children		3 years

Secondary Outcomes

Measure	Description	Time Frame
Five other scales from the Self-Perception Profile for Children		3 years
Change in cycloplegic autorefraction		3 years
Change in axial length, measured by A-scan ultrasound

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.00 to 6.00 D spherical component myopia, based on cycloplegic autorefraction
1.00 DC or less astigmatism, based on cycloplegic autorefraction
20/20 or better best-corrected visual acuity in each eye
Global stereoacuity of 250 seconds of arc or better based on Randot stereoacuity

Exclusion Criteria:

Contact lens wear within the past month
Ocular health problems that could affect vision, eye development, or contact lens wear
Systemic health problems that could affect understanding of surveys or contact lens wear
Participation in other eye or vision studies that prescribed a treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey J Walline, OD, PhD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New England College of Optometry		Boston	Massachusetts	02215	United States
Ohio State University College of Optometry

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16432471	Background	Walline JJ, Jones LA, Chitkara M, Coffey B, Jackson JM, Manny RE, Rah MJ, Prinstein MJ, Zadnik K. The Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) study design and baseline data. Optom Vis Sci. 2006 Jan;83(1):37-45. doi: 10.1097/01.opx.0000195566.94572.eb.
15097767	Background

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D003263	Contact Lenses, Hydrophilic
D005139	Eyeglasses

ID	Term
D003261	Contact Lenses
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies