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Completed

NCT Number: NCT00522288

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

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New England College of Optometry, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soft contact lenses

Device

Daily wear soft contact lenses disposed of daily or biweekly

Other names: 1 Day Acuvue or Acuvue 2 contact lenses

Spectacle

Device

Spectacles for the treatment of myopia

Other names: Children chose their own frames.

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. Five other scales from the Self-Perception Profile for Children

    Time frame: 3 years

  2. Change in cycloplegic autorefraction

    Time frame: 3 years

  3. Change in axial length, measured by A-scan ultrasound

    Time frame: 3 years

  4. Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer

    Time frame: 3 years

  5. Change in Overall score from the Pediatric Refractive Error Profile

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Johnson & Johnson Vision Care, Inc.

Registry information

Official study title

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

Acronym: ACHIEVE

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Aug 29, 2007
Registry last updated
Mar 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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