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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT01704729

Collaborator

(none)

2,300

Enrollment

Location

Arms

Duration (Months)

53.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Myopia	Procedure: group1 Procedure: group2 Procedure: group3 Procedure: group4	N/A

Detailed 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)

Study Design

Study Type:

Interventional

Actual Enrollment :

2300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Visual acuity with and without study refractive correction [2 months]

Secondary Outcome Measures

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]

Other Outcome Measures

Breakage, damage and loss of spectacles [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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