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Completed

NCT Number: NCT02231606

Potentiating Rural Investment in Children's Eyecare (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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free Glasses

Other

Provide free glasses

Upgrade Glasses 1

Other

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

Other

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 outcomes

  1. Glasses purchase proportion

    Time frame: 8 months after the start of the project.

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

Secondary outcomes

  1. Wearing spectacles proportion

    Time frame: 8 months after the start of the project.

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

Other outcomes

  1. Visual acuity

    Time frame: 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

  2. Mydriatic refraction results

    Time frame: 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.

  3. Family economic conditions

    Time frame: At the first week of the study

    Collect the children's family economic information on baseline survey.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Orbis
  • Rural Education Action Project
  • Second People's Hospital of Yunnan Province
  • The Fred Hollows Foundation
  • United States Agency for International Development (USAID)

Registry information

Acronym: PRICE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2014
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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