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

Ohio State University5 sites in 1 country484 target enrollmentSeptember 2003

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Ohio State University
Enrollment: 484
Locations: 5
Primary Endpoint: Global Self-Worth Scale from the Self-Perception Profile for Children
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

October 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ohio State University

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

Outcomes

Primary Outcomes

Global Self-Worth Scale from the Self-Perception Profile for Children

Time Frame: 3 years

Secondary Outcomes

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)