MyopiaWEARNCT01704729
The Children's WEAR Trial(Phase 1&2)
A study testing group1, group2 and group3 in people with Myopia, run by Sun Yat-sen University at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Myopia
- What is being tested?
- group1, group2 and group3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to 1 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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)
- Conditions
- Myopia
- Being tested
- group1, group2, group3, group4
- Keywords
- Myopia, Focus groups, refraction, Glasses, spectacles
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group1Procedure or surgery
Non-cycloplegic self-refraction +conventional glasses
group2Procedure or surgery
Cycloplegic subjective refraction by experienced optometrist +conventional glasses
group3Procedure or surgery
Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses
group4Procedure or surgery
Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses
| Study group | Role | What they receive |
|---|---|---|
| group2 | Other | Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist Receives: Procedure: group2 |
| group3 | Other | Cycloplegic subjective refraction by a "vision technician" trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program Receives: Procedure: group3 |
| group4 | Other | Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist Receives: Procedure: group4 |
| group1 | Other | Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol Receives: Procedure: group1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity with and without study refractive correction
Measured: 2 months
Secondary outcomes (4)
Self-reported and Supplemental visual functioning
Measured: 2 months
frequency of glasses-wear and the reason why the frequency is low
Measured: 2 months
Accuracy of spectacles given to children
Measured: 2 months
Value attached to the glasses and satisfaction to the glasses
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2012
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan G Congdon, MD,MPH, Principal investigator, Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704729
- Sponsor's protocol ID
- ZOC-WEAR-1
- Acronym
- WEAR
- Status last verified
- Mar 2021
- First submitted
- 20 Sep 2012
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)
- ClinicalTrials.gov ID
- NCT01704729
- Acronym / sponsor ID
- WEAR / ZOC-WEAR-1
- Conditions
- Myopia
- Keywords
- Myopia, Focus groups, refraction, Glasses, spectacles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group2 | Other | Procedure: group2Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist |
| group3 | Other | Procedure: group3Cycloplegic subjective refraction by a "vision technician" trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program |
| group4 | Other | Procedure: group4Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist |
| group1 | Other | Procedure: group1Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group1Non-cycloplegic self-refraction +conventional glasses | Procedure or surgery | group1 |
| group2Cycloplegic subjective refraction by experienced optometrist +conventional glasses | Procedure or surgery | group2 |
| group3Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses | Procedure or surgery | group3 |
| group4Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses | Procedure or surgery | group4 |
Primary outcome
Visual acuity with and without study refractive correction
Time frame: 2 months
4 secondary outcomes
Self-reported and Supplemental visual functioning
Time frame: 2 months
frequency of glasses-wear and the reason why the frequency is low
Time frame: 2 months
Accuracy of spectacles given to children
Time frame: 2 months
Value attached to the glasses and satisfaction to the glasses
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan G Congdon, MD,MPH principal investigator
Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group1, group2 and group3 in people with Myopia, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity with and without study refractive correction (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.