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

This study has been completed.
Sponsor:
Collaborator:
Vistakon
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00522288
First received: August 28, 2007
Last updated: March 17, 2011
Last verified: March 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Five other scales from the Self-Perception Profile for Children [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in cycloplegic autorefraction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in axial length, measured by A-scan ultrasound [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in Overall score from the Pediatric Refractive Error Profile [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 484
Study Start Date: September 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contact Lens
Soft contact lenses
Device: Soft contact lenses
Daily wear soft contact lenses disposed of daily or biweekly
Other Name: 1 Day Acuvue or Acuvue 2 contact lenses
Active Comparator: Spectacle
Spectacles
Device: Spectacle
Spectacles for the treatment of myopia
Other Name: Children chose their own frames.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Jeffrey J. Walline, OD, PhD, College of Optometry, The Ohio State University
ClinicalTrials.gov Identifier: NCT00522288     History of Changes
Other Study ID Numbers: 2003H0114
Study First Received: August 28, 2007
Last Updated: March 17, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014