Potentiating Rural Investment in Children's Eyecare (PRICE)

Myopia Clinical Trial

— PRICE  

Official title:

Potentiating Rural Investment in Children's Eyecare (PRICE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231606
• Other study ID #: ZOC-PRICE
• Status: Completed
• Phase: N/A
• First received: August 31, 2014
• Last updated: March 7, 2016
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10234
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Free Glasses
Provide free glasses
• 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)
• 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)

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (6)

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

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Other	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.	No
Other	Family economic conditions	Collect the children's family economic information on baseline survey.	At the first week of the study	No
Primary	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.	No
Secondary	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.	No