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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01704729
Acronym
WEAR
Enrollment
2300
Registered
2012-10-11
Start date
2012-09-30
Completion date
2016-04-01
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Myopia, Focus groups, refraction, Glasses, spectacles

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)

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)

Interventions

PROCEDUREgroup1

Non-cycloplegic self-refraction +conventional glasses

PROCEDUREgroup2

Cycloplegic subjective refraction by experienced optometrist +conventional glasses

PROCEDUREgroup3

Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses

PROCEDUREgroup4

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

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Visual acuity with and without study refractive correction2 months

Secondary

MeasureTime frame
Self-reported and Supplemental visual functioning2 months
frequency of glasses-wear and the reason why the frequency is low2 months
Accuracy of spectacles given to children2 months
Value attached to the glasses and satisfaction to the glasses2 months

Other

MeasureTime frame
Breakage, damage and loss of spectacles2 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026