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

Sun Yat-sen University2,300 enrolled

Overview

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)

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

2,300

Conditions

Myopia

Interventions

group1PROCEDURE

Non-cycloplegic self-refraction +conventional glasses

group2PROCEDURE

Cycloplegic subjective refraction by experienced optometrist +conventional glasses

group3PROCEDURE

Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Visual acuity with and without study refractive correction

Time frame: 2 months

Secondary Outcomes

Self-reported and Supplemental visual functioning

Time frame: 2 months

frequency of glasses-wear and the reason why the frequency is low

Time frame: 2 months

Accuracy of spectacles given to children

Time frame: 2 months

Value attached to the glasses and satisfaction to the glasses

Time frame: 2 months

Data from ClinicalTrials.gov

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