The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,300
- Locations
- 1
- Primary Endpoint
- Visual acuity with and without study refractive correction
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
group2
Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist
Intervention: group2 (Procedure)
group3
Cycloplegic subjective refraction by a "vision technician" trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program
Intervention: group3 (Procedure)
group4
Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist
Intervention: group4 (Procedure)
group1
Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol
Intervention: group1 (Procedure)
Outcomes
Primary Outcomes
Visual acuity with and without study refractive correction
Time Frame: 2 months
Secondary Outcomes
- Value attached to the glasses and satisfaction to the glasses(2 months)
- frequency of glasses-wear and the reason why the frequency is low(2 months)
- Self-reported and Supplemental visual functioning(2 months)
- Accuracy of spectacles given to children(2 months)
Investigators
Congdon Nathan
MD,MPH
Sun Yat-sen University