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

Sun Yat-sen University

Status: Completed

Conditions: Myopia

Treatments: Procedure: group3; Procedure: group4; Procedure: group1; Procedure: group2

Study type: Interventional

Funder types: Other

Identifiers

NCT01704729

ZOC-WEAR-1

Details and patient eligibility

About

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)

Full description

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)

Enrollment: 2,300 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,300 participants in 4 patient groups

group2

Other group

Description:

Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist

Treatment:

Procedure: group2

group3

Other group

Description:

Cycloplegic subjective refraction by a "vision technician" trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program

Treatment:

Procedure: group3

group4

Other group

Description:

Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist

Treatment:

Procedure: group4

group1

Other group

Description:

Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol

Treatment:

Procedure: group1