search
Back to results

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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Free Glasses
Upgrade Glasses 1
Upgrade Glasses 2
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Myopia focused on measuring Myopia Prevalence, Proportion of Purchase of free Spectacles, Proportion of Purchase of update Spectacles, Proportion of Wearing Spectacles

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Group 1: Pure Control

Group 2: Free Glasses

Group 3: Free + Upgrade Glasses 1

Group 4: Free + Upgrade Glasses 2

Arm Description

Provision of glasses prescription only

Free glasses for all, no upgrade glasses offered

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)

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)

Outcomes

Primary Outcome Measures

Glasses purchase proportion
Proportion of children in each group requiring glasses whose families select to purchase them.

Secondary Outcome Measures

Wearing spectacles proportion
Proportion of children who actually wearing glasses at an unannounced check at endline survey.

Full Information

First Posted
August 31, 2014
Last Updated
March 7, 2016
Sponsor
Sun Yat-sen University
Collaborators
Orbis, United States Agency for International Development (USAID), The Fred Hollows Foundation, Rural Education Action Project, Second People's Hospital of Yunnan Province
search

1. Study Identification

Unique Protocol Identification Number
NCT02231606
Brief Title
Potentiating Rural Investment in Children's Eyecare (PRICE)
Acronym
PRICE
Official Title
Potentiating Rural Investment in Children's Eyecare (PRICE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Orbis, United States Agency for International Development (USAID), The Fred Hollows Foundation, Rural Education Action Project, Second People's Hospital of Yunnan Province

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia Prevalence, Proportion of Purchase of free Spectacles, Proportion of Purchase of update Spectacles, Proportion of Wearing Spectacles

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Pure Control
Arm Type
No Intervention
Arm Description
Provision of glasses prescription only
Arm Title
Group 2: Free Glasses
Arm Type
Experimental
Arm Description
Free glasses for all, no upgrade glasses offered
Arm Title
Group 3: Free + Upgrade Glasses 1
Arm Type
Experimental
Arm 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)
Arm Title
Group 4: Free + Upgrade Glasses 2
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
Free Glasses
Intervention Description
Provide free glasses
Intervention Type
Other
Intervention Name(s)
Upgrade Glasses 1
Intervention 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)
Intervention Type
Other
Intervention Name(s)
Upgrade Glasses 2
Intervention 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)
Primary Outcome Measure Information:
Title
Glasses purchase proportion
Description
Proportion of children in each group requiring glasses whose families select to purchase them.
Time Frame
8 months after the start of the project.
Secondary Outcome Measure Information:
Title
Wearing spectacles proportion
Description
Proportion of children who actually wearing glasses at an unannounced check at endline survey.
Time Frame
8 months after the start of the project.
Other Pre-specified Outcome Measures:
Title
Visual acuity
Description
There are three times of vision acuity(VA) check. The baseline VA, the fraction VA and the endline VA with and without glasses
Time Frame
At the first week of the study, two months later, and six months later.
Title
Mydriatic refraction results
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.
Time Frame
One month after visual screening.
Title
Family economic conditions
Description
Collect the children's family economic information on baseline survey.
Time Frame
At the first week of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD, MPH
Organizational Affiliation
The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
14985292
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.
Results Reference
background
PubMed Identifier
24327616
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.
Results Reference
background
PubMed Identifier
20547954
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.
Results Reference
background
PubMed Identifier
19104465
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.
Results Reference
background
PubMed Identifier
29161286
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.
Results Reference
derived

Learn more about this trial

Potentiating Rural Investment in Children's Eyecare (PRICE)

We'll reach out to this number within 24 hrs