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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
group1
group2
group3
group4
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Myopia focused on measuring Myopia, Focus groups, refraction, Glasses, spectacles

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

group2

group3

group4

group1

Arm Description

Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist

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

Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist

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

Outcomes

Primary Outcome Measures

Visual acuity with and without study refractive correction

Secondary Outcome Measures

Self-reported and Supplemental visual functioning
frequency of glasses-wear and the reason why the frequency is low
Accuracy of spectacles given to children
Value attached to the glasses and satisfaction to the glasses

Full Information

First Posted
September 20, 2012
Last Updated
March 18, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01704729
Brief Title
The Children's WEAR Trial(Phase 1&2)
Acronym
WEAR
Official Title
The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 1, 2016 (Actual)
Study Completion Date
April 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. 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)
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, Focus groups, refraction, Glasses, spectacles

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group2
Arm Type
Other
Arm Description
Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist
Arm Title
group3
Arm Type
Other
Arm Description
Cycloplegic subjective refraction by a "vision technician" trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program
Arm Title
group4
Arm Type
Other
Arm Description
Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist
Arm Title
group1
Arm Type
Other
Arm Description
Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol
Intervention Type
Procedure
Intervention Name(s)
group1
Intervention Description
Non-cycloplegic self-refraction +conventional glasses
Intervention Type
Procedure
Intervention Name(s)
group2
Intervention Description
Cycloplegic subjective refraction by experienced optometrist +conventional glasses
Intervention Type
Procedure
Intervention Name(s)
group3
Intervention Description
Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses
Intervention Type
Procedure
Intervention Name(s)
group4
Intervention Description
Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses
Primary Outcome Measure Information:
Title
Visual acuity with and without study refractive correction
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Self-reported and Supplemental visual functioning
Time Frame
2 months
Title
frequency of glasses-wear and the reason why the frequency is low
Time Frame
2 months
Title
Accuracy of spectacles given to children
Time Frame
2 months
Title
Value attached to the glasses and satisfaction to the glasses
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Breakage, damage and loss of spectacles
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan G Congdon, MD,MPH
Organizational Affiliation
Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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

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