MyopiaWEARIIINCT02529540
WEAR (Wearability and Evaluation of Adjustable Refraction) III
A study testing Adjustable glasses, Custom standard glasses and Ready-made glasses in people with Myopia, run by Sun Yat-sen University.
Trial summary
Two-month randomized trial comparing three groups. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Myopia
- What is being tested?
- Adjustable glasses, Custom standard glasses and Ready-made glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 Jun 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 11-16 years old middle school students from two locations in Guangdong Province.
- With ≤ -1.00 Diopter of myopic refractive error in each eye.
- With uncorrected vision ≤ 6/12 in both eyes thought to be due to refractive error (that is, correctable to at least 6/7.5 with subjective refraction by an optometrist).
- With informed consents(There are two types of informed consents. One of them is whether the parents of the students agree their kids to participate in the project. The other informed consent is whether the parents agree their kids to have the cycloplegic refraction. If the students were admitted to participate in project but without being agreed to have cycloplegic refraction by their parents , they would have non cycloplegic retinoscopy.).
Who cannot join
- Those corrected VA can not up to 6/7.5 with 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.
About this study
Official title: WEAR (Wearability and Evaluation of Adjustable Refraction) III: A Randomized Non-inferiority Trial of Children's Wear of Adjustable Glasses
Two-month randomized trial comparing three groups.
Read the detailed description
Two-month randomized non-inferiority trial (the margin of non-inferiority is 20%) comparing three groups: self-refraction with adjustable glasses, receiving adjustable glasses; subjective refraction by an expert refractionist after computer optometry and receiving custom standard glasses; subjective refraction by an expert refractionist after computer optometry and receiving ready-made glasses. The main outcome of this study is the rate of glasses wear on twice-weekly covert evaluation by head teachers. And the continuous teacher assessment of wearing study glasses will be calculated as the number of times wearing glasses/ Total number of separate observations.
- Conditions
- Myopia
- Being tested
- Adjustable glasses, Custom standard glasses, Ready-made glasses
- Keywords
- Myopia, self-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.
Adjustable glassesOther
The glasses will be used for refraction and wearing within professional instructions.
Custom standard glassesOther
The custom standard glasses are made by the traditional standards after refraction.
Ready-made glassesOther
The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Self-refraction with adjustable glasses Receives: Other: Adjustable glasses |
| Group 2 | Other | Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses Receives: Other: Custom standard glasses |
| Group 3 | Other | Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses Receives: Other: Ready-made glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearing spectacles proportion
The participators in each group may have the different wearing spectacles proportion.
Measured: 5 months after the start of the project
Secondary outcomes (1)
The quality of life after wearing glasses(questionnaires)
The quality of life will be learned by questionnaires
Measured: 5 months after the start of the project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start1 Sep 2015
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Model description
- This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Gaozhou Hospital of Traditional Chinese Medicine, Xinyi traditional Chinese medicine hospital
- Responsible party
- Principal investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan Congdon, MD, MPH, Principal investigator, The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529540
- Sponsor's protocol ID
- ZOC-WEAR 3
- Acronym
- WEARIII
- Status last verified
- Oct 2018
- First submitted
- 16 Aug 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
PubMed 14985292He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719.
PubMed 19104465Li L, Lam J, Lu Y, Ye Y, Lam DS, Gao Y, Sharma A, Zhang M, Griffiths S, Congdon N. Attitudes of students, parents, and teachers toward glasses use in rural China. Arch Ophthalmol. 2010 Jun;128(6):759-65. doi: 10.1001/archophthalmol.2010.73.
PubMed 20547954He M, Congdon N, MacKenzie G, Zeng Y, Silver JD, Ellwein L. The child self-refraction study results from urban Chinese children in Guangzhou. Ophthalmology. 2011 Jun;118(6):1162-9. doi: 10.1016/j.ophtha.2010.10.003. Epub 2011 Jan 12.
PubMed 21232802Zhou Z, Zeng J, Ma X, Pang X, Yi H, Chen Q, Meltzer ME, He M, Rozelle S, Congdon N. Accuracy of rural refractionists in western China. Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):154-61. doi: 10.1167/iovs.13-13250.
PubMed 24327616Wang CY, Zhang G, Tang B, Jin L, Huang W, Wang X, Chen T, Zhu W, Xiao B, Wang J, Zhou Z, Tang Z, Liang Y, Crescioni M, Wilson D, McAneney H, Silver JD, Moore B, Congdon N. A Randomized Noninferiority Trial of Wearing Adjustable Glasses versus Standard and Ready-made Spectacles among Chinese Schoolchildren: Wearability and Evaluation of Adjustable Refraction III. Ophthalmology. 2020 Jan;127(1):27-37. doi: 10.1016/j.ophtha.2019.08.002. Epub 2019 Aug 14.
PubMed 31543351
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEAR (Wearability and Evaluation of Adjustable Refraction) III: A Randomized Non-inferiority Trial of Children's Wear of Adjustable Glasses
- ClinicalTrials.gov ID
- NCT02529540
- Acronym / sponsor ID
- WEARIII / ZOC-WEAR 3
- Conditions
- Myopia
- Keywords
- Myopia, self-refraction, glasses, spectacles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Gaozhou Hospital of Traditional Chinese Medicine, Xinyi traditional Chinese medicine hospital
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 20 Aug 2015 (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.
Two-month randomized trial comparing three groups.
Detailed description
Two-month randomized non-inferiority trial (the margin of non-inferiority is 20%) comparing three groups: self-refraction with adjustable glasses, receiving adjustable glasses; subjective refraction by an expert refractionist after computer optometry and receiving custom standard glasses; subjective refraction by an expert refractionist after computer optometry and receiving ready-made glasses. The main outcome of this study is the rate of glasses wear on twice-weekly covert evaluation by head teachers. And the continuous teacher assessment of wearing study glasses will be calculated as the number of times wearing glasses/ Total number of separate observations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Adjustable glassesSelf-refraction with adjustable glasses |
| Group 2 | Other | Other: Custom standard glassesSubjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses |
| Group 3 | Other | Other: Ready-made glassesSubjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 11-16 years old middle school students from two locations in Guangdong Province.
- With ≤ -1.00 Diopter of myopic refractive error in each eye.
- With uncorrected vision ≤ 6/12 in both eyes thought to be due to refractive error (that is, correctable to at least 6/7.5 with subjective refraction by an optometrist).
- With informed consents(There are two types of informed consents. One of them is whether the parents of the students agree their kids to participate in the project. The other informed consent is whether the parents agree their kids to have the cycloplegic refraction. If the students were admitted to participate in project but without being agreed to have cycloplegic refraction by their parents , they would have non cycloplegic retinoscopy.).
Key exclusion criteria (3 listed)
- Those corrected VA can not up to 6/7.5 with 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 |
|---|---|---|
| Adjustable glassesThe glasses will be used for refraction and wearing within professional instructions. | Other | Group 1 |
| Custom standard glassesThe custom standard glasses are made by the traditional standards after refraction. | Other | Group 2 |
| Ready-made glassesThe glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction. | Other | Group 3 |
Primary outcome
Wearing spectacles proportion
Time frame: 5 months after the start of the project
The participators in each group may have the different wearing spectacles proportion.
1 secondary outcome
The quality of life after wearing glasses(questionnaires)
Time frame: 5 months after the start of the project
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 15 Oct 2018.
- Background: PubMed 14985292He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
- Background: PubMed 19104465He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719.
- Background: PubMed 20547954Li L, Lam J, Lu Y, Ye Y, Lam DS, Gao Y, Sharma A, Zhang M, Griffiths S, Congdon N. Attitudes of students, parents, and teachers toward glasses use in rural China. Arch Ophthalmol. 2010 Jun;128(6):759-65. doi: 10.1001/archophthalmol.2010.73.
- Background: PubMed 21232802He M, Congdon N, MacKenzie G, Zeng Y, Silver JD, Ellwein L. The child self-refraction study results from urban Chinese children in Guangzhou. Ophthalmology. 2011 Jun;118(6):1162-9. doi: 10.1016/j.ophtha.2010.10.003. Epub 2011 Jan 12.
- Background: PubMed 24327616Zhou Z, Zeng J, Ma X, Pang X, Yi H, Chen Q, Meltzer ME, He M, Rozelle S, Congdon N. Accuracy of rural refractionists in western China. Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):154-61. doi: 10.1167/iovs.13-13250.
- Derived from this study: PubMed 31543351Wang CY, Zhang G, Tang B, Jin L, Huang W, Wang X, Chen T, Zhu W, Xiao B, Wang J, Zhou Z, Tang Z, Liang Y, Crescioni M, Wilson D, McAneney H, Silver JD, Moore B, Congdon N. A Randomized Noninferiority Trial of Wearing Adjustable Glasses versus Standard and Ready-made Spectacles among Chinese Schoolchildren: Wearability and Evaluation of Adjustable Refraction III. Ophthalmology. 2020 Jan;127(1):27-37. doi: 10.1016/j.ophtha.2019.08.002. Epub 2019 Aug 14.
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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 Congdon, MD, MPH principal investigator
The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable glasses, Custom standard glasses and Ready-made glasses in people with Myopia, run by Sun Yat-sen University.
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 4 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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Wearing spectacles proportion (time frame: 5 months after the start of the project). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529540, which also lists 6 linked publications.
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 15 Oct 2018.