MyopiaPRICENCT02231606
Potentiating Rural Investment in Children's Eyecare (PRICE)
A study testing Free Glasses, Upgrade Glasses 1 and Upgrade Glasses 2 in people with Myopia, run by Sun Yat-sen University at 1 site in China.
Trial summary
The aim of the project is to create, study and advocate for a model that can be adopted by the Chinese government to provide spectacles for all children sustainable. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Free Glasses, Upgrade Glasses 1 and Upgrade Glasses 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,234 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jul 2015
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Randomly selected primary schools, which has all 3, 4 and 5 grades, in the 9 project counties.
- A class randomly selected from each grade of 3, 4, and 5 grades of the selected primary schools.
- All children in the selected classes.
Who cannot join
- Those schools that the total number of students are more than 2000.
- Those schools that the total number of students of 3, 4, 5 grades are less than 80.
- Children suffering from eye diseases such as cataract, congenital ptosis, strabismus, congenital glaucoma will not be included in the study and will be recommended referral.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the project is to create, study and advocate for a model that can be adopted by the Chinese government to provide spectacles for all children sustainable.
Read the detailed description
Uncorrected refractive error (URE) is the leading cause of visual impairment among Chinese children, accounting for 90% or more of poor vision, and Chinese children have among the highest rates of myopia in the world. Despite the fact that the problem of URE is safely and inexpensively treated with glasses, only 15-40% of children needing them own and wear glasses sufficient to provide good vision in rural China.
PRICE (Potentiating Rural Investment in Children's Eyecare) will use a randomized, controlled design across 4 groups of all 138 schools in Yunnan (one of China's poorest provinces) and Guangdong (one of the richest) to optimize the model of "free glasses for all with an optional upgrade." The selection of free spectacles and cost of the "upgrade" options will be varied between groups in order to find the optimal balance between high rates of purchase of upgrade glasses on the one hand and good acceptance and wear of free spectacles among those selecting them on the other.
- Conditions
- Myopia
- Being tested
- Free Glasses, Upgrade Glasses 1, Upgrade Glasses 2
- Keywords
- Myopia Prevalence, Proportion of Purchase of free Spectacles, Proportion of Purchase of update Spectacles, Proportion of Wearing Spectacles
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free GlassesOther
Provide free glasses
Upgrade Glasses 1Other
Provide optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD)
Upgrade Glasses 2Other
Provide optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pure Control | No intervention | Provision of glasses prescription only |
| Group 2: Free Glasses | Experimental | Free glasses for all, no upgrade glasses offered Receives: Other: Free Glasses |
| Group 3: Free + Upgrade Glasses 1 | Experimental | Free glasses for all, optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD) Receives: Other: Free Glasses; Other: Upgrade Glasses 1 |
| Group 4: Free + Upgrade Glasses 2 | Experimental | Free glasses for all, optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD) Receives: Other: Free Glasses; Other: Upgrade Glasses 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasses purchase proportion
Proportion of children in each group requiring glasses whose families select to purchase them.
Measured: 8 months after the start of the project.
Secondary outcomes (1)
Wearing spectacles proportion
Proportion of children who actually wearing glasses at an unannounced check at endline survey.
Measured: 8 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 posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis, United States Agency for International Development (USAID), The Fred Hollows Foundation, Rural Education Action Project, Second People's Hospital of Yunnan Province
- 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
- NCT02231606
- Sponsor's protocol ID
- ZOC-PRICE
- Acronym
- PRICE
- Status last verified
- Mar 2016
- First submitted
- 31 Aug 2014
- Last updated
- 9 Mar 2016
- 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 14985292Zhou 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 24327616Li 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, 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 19104465Wang X, Congdon N, Ma Y, Hu M, Zhou Y, Liao W, Jin L, Xiao B, Wu X, Ni M, Yi H, Huang Y, Varga B, Zhang H, Cun Y, Li X, Yang L, Liang C, Huang W, Rozelle S, Ma X. Cluster-randomized controlled trial of the effects of free glasses on purchase of children's glasses in China: The PRICE (Potentiating Rural Investment in Children's Eyecare) study. PLoS One. 2017 Nov 21;12(11):e0187808. doi: 10.1371/journal.pone.0187808. eCollection 2017.
PubMed 29161286
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potentiating Rural Investment in Children's Eyecare (PRICE)
- ClinicalTrials.gov ID
- NCT02231606
- Acronym / sponsor ID
- PRICE / ZOC-PRICE
- Conditions
- Myopia
- Keywords
- Myopia Prevalence, Proportion of Purchase of free Spectacles, Proportion of Purchase of update Spectacles, Proportion of Wearing Spectacles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,234 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Orbis, United States Agency for International Development (USAID), The Fred Hollows Foundation, Rural Education Action Project, Second People's Hospital of Yunnan Province
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Sep 2014 (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.
The aim of the project is to create, study and advocate for a model that can be adopted by the Chinese government to provide spectacles for all children sustainable.
Detailed description
Uncorrected refractive error (URE) is the leading cause of visual impairment among Chinese children, accounting for 90% or more of poor vision, and Chinese children have among the highest rates of myopia in the world. Despite the fact that the problem of URE is safely and inexpensively treated with glasses, only 15-40% of children needing them own and wear glasses sufficient to provide good vision in rural China.
PRICE (Potentiating Rural Investment in Children's Eyecare) will use a randomized, controlled design across 4 groups of all 138 schools in Yunnan (one of China's poorest provinces) and Guangdong (one of the richest) to optimize the model of "free glasses for all with an optional upgrade." The selection of free spectacles and cost of the "upgrade" options will be varied between groups in order to find the optimal balance between high rates of purchase of upgrade glasses on the one hand and good acceptance and wear of free spectacles among those selecting them on the other.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pure Control | No intervention | –Provision of glasses prescription only |
| Group 2: Free Glasses | Experimental | Other: Free GlassesFree glasses for all, no upgrade glasses offered |
| Group 3: Free + Upgrade Glasses 1 | Experimental | Other: Free Glasses, Other: Upgrade Glasses 1Free glasses for all, optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD) |
| Group 4: Free + Upgrade Glasses 2 | Experimental | Other: Free Glasses, Other: Upgrade Glasses 2Free glasses for all, optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD) |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Randomly selected primary schools, which has all 3, 4 and 5 grades, in the 9 project counties.
- A class randomly selected from each grade of 3, 4, and 5 grades of the selected primary schools.
- All children in the selected classes.
Key exclusion criteria (3 listed)
- Those schools that the total number of students are more than 2000.
- Those schools that the total number of students of 3, 4, 5 grades are less than 80.
- Children suffering from eye diseases such as cataract, congenital ptosis, strabismus, congenital glaucoma will not be included in the study and will be recommended referral.
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 |
|---|---|---|
| Free GlassesProvide free glasses | Other | Group 2: Free Glasses, Group 3: Free + Upgrade Glasses 1, Group 4: Free + Upgrade Glasses 2 |
| Upgrade Glasses 1Provide optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD) | Other | Group 3: Free + Upgrade Glasses 1 |
| Upgrade Glasses 2Provide optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD) | Other | Group 4: Free + Upgrade Glasses 2 |
Primary outcome
Glasses purchase proportion
Time frame: 8 months after the start of the project.
Proportion of children in each group requiring glasses whose families select to purchase them.
1 secondary outcome
Wearing spectacles proportion
Time frame: 8 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 9 Mar 2016.
- 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 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.
- 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 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.
- Derived from this study: PubMed 29161286Wang X, Congdon N, Ma Y, Hu M, Zhou Y, Liao W, Jin L, Xiao B, Wu X, Ni M, Yi H, Huang Y, Varga B, Zhang H, Cun Y, Li X, Yang L, Liang C, Huang W, Rozelle S, Ma X. Cluster-randomized controlled trial of the effects of free glasses on purchase of children's glasses in China: The PRICE (Potentiating Rural Investment in Children's Eyecare) study. PLoS One. 2017 Nov 21;12(11):e0187808. doi: 10.1371/journal.pone.0187808. eCollection 2017.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Glasses, Upgrade Glasses 1 and Upgrade Glasses 2 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 9 Mar 2016. 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?
Glasses purchase proportion (time frame: 8 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 NCT02231606, which also lists 5 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 9 Mar 2016.