Potentiating Rural Investment in Children's Eyecare (PRICE)

Sun Yat-sen University

Status: Completed

Conditions: Myopia

Treatments: Other: Upgrade Glasses 1; Other: Free Glasses; Other: Upgrade Glasses 2

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02231606

ZOC-PRICE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,234 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10,234 participants in 4 patient groups

Group 1: Pure Control

No Intervention group

Description:

Provision of glasses prescription only

Group 2: Free Glasses

Experimental group

Description:

Free glasses for all, no upgrade glasses offered

Treatment:

Other: Free Glasses

Group 3: Free + Upgrade Glasses 1

Experimental group

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)

Treatment:

Other: Upgrade Glasses 1

Other: Free Glasses

Group 4: Free + Upgrade Glasses 2

Experimental group

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)

Treatment:

Other: Free Glasses

Other: Upgrade Glasses 2