Clinical trial NCT02231606: Potentiating Rural Investment in Children's Eyecare (PRICE)
Official title: Potentiating Rural Investment in Children's Eyecare (PRICE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Myopia Prevalence
Proportion of Purchase of free Spectacles
Proportion of Purchase of update Spectacles
Proportion of Wearing Spectacles
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Orbis
name: United States Agency for International Development (USAID)
name: The Fred Hollows Foundation
name: Rural Education Action Project
name: Second People's Hospital of Yunnan Province
First posted: 2014-09-04
Enrollment: 10234
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Randomly selected primary schools, which has all 3, 4 and 5 grades, in the 9 project counties.
2. A class randomly selected from each grade of 3, 4, and 5 grades of the selected primary schools.
3. All children in the selected classes.

Exclusion Criteria:

1. Those schools that the total number of students are more than 2000.
2. Those schools that the total number of students of 3, 4, 5 grades are less than 80.
3. 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.

Primary outcomes:
measure: Glasses purchase proportion
timeFrame: 8 months after the start of the project.
Secondary outcomes:
measure: Wearing spectacles proportion
timeFrame: 8 months after the start of the project.
Other outcomes:
measure: Visual acuity
timeFrame: At the first week of the study, two months later, and six months later.
measure: Mydriatic refraction results
timeFrame: One month after visual screening.
measure: Family economic conditions
timeFrame: At the first week of the study
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Nathan Congdon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.