The Children's WEAR Trial(Phase 1&2)

Study Overview
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Brief Summary
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Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: (September 2012 - August 2013)

Detailed Description
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Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: self-refraction with adjustable glasses, receiving custom standard glasses; subjective refraction by an expert refractionist after cycloplegic automated refraction and receiving custom standard glasses; subjective refraction by a rural refractionist after cycloplegic automated refraction, receiving custom standard glasses; and subjective refraction by an expert refractionist after cycloplegic automated refraction receiving ready made glasses (September 2012 - August 2013)

Official Title
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The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)

Conditions
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Myopia

Intervention / Treatment
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* Procedure: group1
* Procedure: group2
* Procedure: group3
* Procedure: group4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: phase1: - aged 12-17 years with <= -1.00D of myopic refractive error in each eye phase2: - 12-15 years old children from two locations in Guangdong Province with uncorrected vision </= 6/12 in at least one eye thought to be due to refractive error (that is, correctable to at least 6/7.5 with cycloplegic subjective refraction by an optometrist) Exclusion Criteria: those corrected VA can not up to 6/7.5 with cycloplegic subjective refraction by an optometrist those with significant strabismus or vision abnormality (keratopathy, cataract, vitreous macular diseases ), or with vision deficiency ( amblyopia ) children are to be excluded. Children developing acquired vision problems other than myopia

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group2<br>Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist | Procedure: group2<br>* Cycloplegic subjective refraction by experienced optometrist +conventional glasses<br>|
| Other: group3<br>Cycloplegic subjective refraction by a vision technician trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program | Procedure: group3<br>* Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses<br>|
| Other: group4<br>Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist | Procedure: group4<br>* Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses<br>|
| Other: group1<br>Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol | Procedure: group1<br>* Non-cycloplegic self-refraction +conventional glasses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity with and without study refractive correction |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported and Supplemental visual functioning |  | 2 months | 
| frequency of glasses-wear and the reason why the frequency is low |  | 2 months | 
| Accuracy of spectacles given to children |  | 2 months | 
| Value attached to the glasses and satisfaction to the glasses |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Focus groups, refraction, Glasses, spectacles