Potentiating Rural Investment in Children's Eyecare (PRICE)

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02231606

Collaborator

Orbis (Other), United States Agency for International Development (USAID) (U.S. Fed), The Fred Hollows Foundation (Other), Rural Education Action Project (Other), Second People's Hospital of Yunnan Province (Other)

10,234

Enrollment

Location

Arms

Duration (Months)

1028

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Other: Free Glasses Other: Upgrade Glasses 1 Other: Upgrade Glasses 2	N/A

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

Study Type:

Interventional

Actual Enrollment :

10234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

Potentiating Rural Investment in Children's Eyecare (PRICE)

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

Glasses purchase proportion [8 months after the start of the project.]
Proportion of children in each group requiring glasses whose families select to purchase them.

Secondary Outcome Measures

Wearing spectacles proportion [8 months after the start of the project.]
Proportion of children who actually wearing glasses at an unannounced check at endline survey.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.