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

March 17, 2011 updated by: Ohio State University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

484

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global Self-Worth Scale from the Self-Perception Profile for Children
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Johnson & Johnson Vision Care, Inc.

Investigators

  • Principal Investigator: Jeffrey J Walline, OD, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimate)

August 29, 2007

Study Record Updates

Last Update Posted (Estimate)

March 21, 2011

Last Update Submitted That Met QC Criteria

March 17, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003H0114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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