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

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT00522288

Collaborator

Johnson & Johnson Vision Care, Inc. (Industry)

484

Enrollment

Locations

Arms

Duration (Months)

96.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Soft contact lenses Device: Spectacle	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

484 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Contact Lens Soft contact lenses	Device: Soft contact lenses Daily wear soft contact lenses disposed of daily or biweekly Other Names: 1 Day Acuvue or Acuvue 2 contact lenses
Active Comparator: Spectacle Spectacles	Device: Spectacle Spectacles for the treatment of myopia Other Names: Children chose their own frames.

Arm

Intervention/Treatment

Experimental: Contact Lens

Soft contact lenses

Device: Soft contact lenses

Daily wear soft contact lenses disposed of daily or biweekly

Other Names:

1 Day Acuvue or Acuvue 2 contact lenses

Active Comparator: Spectacle

Spectacles

Device: Spectacle

Spectacles for the treatment of myopia

Other Names:

Children chose their own frames.

Outcome Measures

Primary Outcome Measures

Global Self-Worth Scale from the Self-Perception Profile for Children [3 years]

Secondary Outcome Measures

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 [3 years]
Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer [3 years]
Change in Overall score from the Pediatric Refractive Error Profile [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New England College of Optometry	Boston	Massachusetts	United States	02215
2	Ohio State University College of Optometry	Columbus	Ohio	United States	43210-1240
3	Pacific University College of Optometry	Forest Grove	Oregon	United States	97116
4	Southern College of Optometry	Memphis	Tennessee	United States	38014
5	University of Houston College of Optometry	Houston	Texas	United States	77204