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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Soft contact lenses; Device: Spectacle

• Registration Number: NCT00522288
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-28
• Study First Posted: 2007-08-29
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-17
• Last Update Posted: 2011-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contact Lens	Soft contact lenses	Soft contact lenses
Spectacle	Spectacle	Spectacles

Primary Outcome Measures

Name	Time	Method
Global Self-Worth Scale from the Self-Perception Profile for Children	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Southern College of Optometry; 🇺🇸 Memphis, Tennessee, United States

University of Houston College of Optometry; 🇺🇸 Houston, Texas, United States

Ohio State University College of Optometry; 🇺🇸 Columbus, Ohio, United States

Pacific University College of Optometry; 🇺🇸 Forest Grove, Oregon, United States

New England College of Optometry; 🇺🇸 Boston, Massachusetts, United States