Potentiating Rural Investment in Children's Eyecare (PRICE) (PRICE)

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Other: Free Glasses; Other: Upgrade Glasses 1; Other: Upgrade Glasses 2

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 Type: Interventional
• Enrollment (Actual): 10234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1: Pure Control; Provision of glasses prescription only
Experimental: Group 2: Free Glasses; Free glasses for all, no upgrade glasses offered	Other: Free Glasses; Provide free glasses
Experimental: Group 3: Free + Upgrade Glasses 1; 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)	Other: Free Glasses; Provide free glasses; Other: Upgrade Glasses 1; 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)
Experimental: Group 4: Free + Upgrade Glasses 2; 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)	Other: Free Glasses; Provide free glasses; Other: Upgrade Glasses 2; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasses purchase proportion	Proportion of children in each group requiring glasses whose families select to purchase them.	8 months after the start of the project.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wearing spectacles proportion	Proportion of children who actually wearing glasses at an unannounced check at endline survey.	8 months after the start of the project.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	There are three times of vision acuity(VA) check. The baseline VA, the fraction VA and the endline VA with and without glasses	At the first week of the study, two months later, and six months later.
Mydriatic refraction results	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.	One month after visual screening.
Family economic conditions	Collect the children's family economic information on baseline survey.	At the first week of the study

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: United States Agency for International Development (USAID); Orbis; The Fred Hollows Foundation; Rural Education Action Project; Second People's Hospital of Yunnan Province

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 31, 2014
• First Submitted That Met QC Criteria: August 31, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Estimate): March 9, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Myopia Prevalence; Proportion of Purchase of free Spectacles; Proportion of Purchase of update Spectacles; Proportion of Wearing Spectacles
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: ZOC-PRICE