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

March 18, 2021 updated by: Congdon Nathan, Sun Yat-sen University

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity with and without study refractive correction
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-reported and Supplemental visual functioning
Time Frame: 2 months
2 months
frequency of glasses-wear and the reason why the frequency is low
Time Frame: 2 months
2 months
Accuracy of spectacles given to children
Time Frame: 2 months
2 months
Value attached to the glasses and satisfaction to the glasses
Time Frame: 2 months
2 months

Other Outcome Measures

Outcome Measure
Time Frame
Breakage, damage and loss of spectacles
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Nathan G Congdon, MD,MPH, Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZOC-WEAR-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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