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

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

Detailed Description
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: Soft contact lenses
* Device: Spectacle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contact Lens<br>Soft contact lenses | Device: Soft contact lenses<br>* Daily wear soft contact lenses disposed of daily or biweekly<br>* Other names: 1 Day Acuvue or Acuvue 2 contact lenses;|
| Active Comparator: Spectacle<br>Spectacles | Device: Spectacle<br>* Spectacles for the treatment of myopia<br>* Other names: Children chose their own frames.;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Self-Perception, Contact Lenses, Glasses, Randomized, Children, Self-esteem