Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-04-16 @ 2:42 PM
Study NCT ID:
NCT02231606
Status:
COMPLETED
Last Update Posted:
2016-03-09
First Post:
2014-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potentiating Rural Investment in Children's Eyecare (PRICE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2014-08-31', 'studyFirstSubmitQcDate': '2014-08-31', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'At the first week of the study, two months later, and six months later.', 'description': 'There are three times of vision acuity(VA) check. The baseline VA, the fraction VA and the endline VA with and without glasses'}, {'measure': 'Mydriatic refraction results', 'timeFrame': 'One month after visual screening.', 'description': 'Those uncorrected VA ≤ 6/12 in either eye and 25% of the students whose uncorrected VA \\> 6/12 in both eyes will receive mydriatic refraction.'}, {'measure': 'Family economic conditions', 'timeFrame': 'At the first week of the study', 'description': "Collect the children's family economic information on baseline survey."}], 'primaryOutcomes': [{'measure': 'Glasses purchase proportion', 'timeFrame': '8 months after the start of the project.', 'description': 'Proportion of children in each group requiring glasses whose families select to purchase them.'}], 'secondaryOutcomes': [{'measure': 'Wearing spectacles proportion', 'timeFrame': '8 months after the start of the project.', 'description': 'Proportion of children who actually wearing glasses at an unannounced check at endline survey.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myopia Prevalence', 'Proportion of Purchase of free Spectacles', 'Proportion of Purchase of update Spectacles', 'Proportion of Wearing Spectacles'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '14985292', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24327616', 'type': 'BACKGROUND', 'citation': 'Zhou 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.'}, {'pmid': '20547954', 'type': 'BACKGROUND', 'citation': 'Li 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.'}, {'pmid': '19104465', 'type': 'BACKGROUND', 'citation': 'He 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.'}, {'pmid': '29161286', 'type': 'DERIVED', 'citation': "Wang 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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPRICE (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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Randomly selected primary schools, which has all 3, 4 and 5 grades, in the 9 project counties.\n2. A class randomly selected from each grade of 3, 4, and 5 grades of the selected primary schools.\n3. All children in the selected classes.\n\nExclusion Criteria:\n\n1. Those schools that the total number of students are more than 2000.\n2. Those schools that the total number of students of 3, 4, 5 grades are less than 80.\n3. 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.'}, 'identificationModule': {'nctId': 'NCT02231606', 'acronym': 'PRICE', 'briefTitle': "Potentiating Rural Investment in Children's Eyecare (PRICE)", 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': "Potentiating Rural Investment in Children's Eyecare (PRICE)", 'orgStudyIdInfo': {'id': 'ZOC-PRICE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1: Pure Control', 'description': 'Provision of glasses prescription only'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Free Glasses', 'description': 'Free glasses for all, no upgrade glasses offered', 'interventionNames': ['Other: Free Glasses']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Free + Upgrade Glasses 1', 'description': '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)', 'interventionNames': ['Other: Free Glasses', 'Other: Upgrade Glasses 1']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Free + Upgrade Glasses 2', 'description': '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)', 'interventionNames': ['Other: Free Glasses', 'Other: Upgrade Glasses 2']}], 'interventions': [{'name': 'Free Glasses', 'type': 'OTHER', 'description': 'Provide free glasses', 'armGroupLabels': ['Group 2: Free Glasses', 'Group 3: Free + Upgrade Glasses 1', 'Group 4: Free + Upgrade Glasses 2']}, {'name': 'Upgrade Glasses 1', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Group 3: Free + Upgrade Glasses 1']}, {'name': 'Upgrade Glasses 2', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Group 4: Free + Upgrade Glasses 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Nathan Congdon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orbis', 'class': 'OTHER'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'The Fred Hollows Foundation', 'class': 'UNKNOWN'}, {'name': 'Rural Education Action Project', 'class': 'UNKNOWN'}, {'name': "Second People's Hospital of Yunnan Province", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD,MPH', 'investigatorFullName': 'Congdon Nathan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}