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

NCT ID: NCT01704729

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-04-01

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)

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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group2

Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist

Group Type OTHER

group2

Intervention Type PROCEDURE

Cycloplegic subjective refraction by experienced optometrist +conventional glasses

group3

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

Group Type OTHER

group3

Intervention Type PROCEDURE

Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses

group4

Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist

Group Type OTHER

group4

Intervention Type PROCEDURE

Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses

group1

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

Group Type OTHER

group1

Intervention Type PROCEDURE

Non-cycloplegic self-refraction +conventional glasses

Interventions

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group1

Non-cycloplegic self-refraction +conventional glasses

Intervention Type PROCEDURE

group2

Cycloplegic subjective refraction by experienced optometrist +conventional glasses

Intervention Type PROCEDURE

group3

Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses

Intervention Type PROCEDURE

group4

Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses

Intervention Type PROCEDURE

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Congdon Nathan

MD,MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nathan G Congdon, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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ZOC-WEAR-1

Identifier Type: -

Identifier Source: org_study_id

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