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

This study is ongoing, but not recruiting participants.

Sponsored by: Ohio State University
Information provided by: Ohio State University
ClinicalTrials.gov Identifier: NCT00522288
  Purpose

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


Condition Intervention
Myopia
Device: Soft contact lenses
Device: Spectacle

MedlinePlus related topics:   Eye Wear   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Effects of Contact Lens Wear on Children's Self-Perceptions

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Global Self-Worth Scale from the Self-Perception Profile for Children [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Five other scales from the Self-Perception Profile for Children [ Time Frame: 3 years ]
  • Change in cycloplegic autorefraction [ Time Frame: 3 years ]
  • Change in axial length, measured by A-scan ultrasound [ Time Frame: 3 years ]
  • Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer [ Time Frame: 3 years ]
  • Change in Overall score from the Pediatric Refractive Error Profile [ Time Frame: 3 years ]

Enrollment:   484
Study Start Date:   September 2003
Estimated Study Completion Date:   October 2007

Arms Assigned Interventions
Contact Lens: Experimental
Soft contact lenses
Device: Soft contact lenses
Daily wear soft contact lenses disposed of daily or biweekly
Spectacle: Active Comparator
Spectacles
Device: Spectacle
Spectacles for the treatment of myopia

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 affect of how much children initially like or dislike to wear glasses on the change in self-perception over three years.

  Eligibility
Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522288

Locations
United States, Massachusetts
New England College of Optometry    
      Boston, Massachusetts, United States, 02215
United States, Ohio
Ohio State University College of Optometry    
      Columbus, Ohio, United States, 43210-1240
United States, Oregon
Pacific University College of Optometry    
      Forest Grove, Oregon, United States, 97116
United States, Tennessee
Southern College of Optometry    
      Memphis, Tennessee, United States, 38014
United States, Texas
University of Houston College of Optometry    
      Houston, Texas, United States, 77204

Sponsors and Collaborators
Ohio State University

Investigators
Principal Investigator:     Jeffrey J Walline, OD, PhD     Ohio State University College of Optometry    
  More Information


Publications:

Study ID Numbers:   GRT961759
First Received:   August 28, 2007
Last Updated:   August 28, 2007
ClinicalTrials.gov Identifier:   NCT00522288
Health Authority:   United States: Institutional Review Board

Keywords provided by Ohio State University:
Myopia  
Self-Perception  
Contact Lenses  
Glasses  
Randomized
Children
Self-esteem

Study placed in the following topic categories:
Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on October 10, 2008




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