NCT02231606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

August 31, 2014

Last Update Submit

March 7, 2016

Conditions

Keywords

Myopia PrevalenceProportion of Purchase of free SpectaclesProportion of Purchase of update SpectaclesProportion of Wearing Spectacles

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Wearing spectacles proportion

    8 months after the start of the project.

Other Outcomes (3)

  • Visual acuity

    At the first week of the study, two months later, and six months later.

  • Mydriatic refraction results

    One month after visual screening.

  • Family economic conditions

    At the first week of the study

Study Arms (4)

Group 1: Pure Control

NO INTERVENTION

Provision of glasses prescription only

Group 2: Free Glasses

EXPERIMENTAL

Free glasses for all, no upgrade glasses offered

Other: Free Glasses

Group 3: Free + Upgrade Glasses 1

EXPERIMENTAL

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 GlassesOther: Upgrade Glasses 1

Group 4: Free + Upgrade Glasses 2

EXPERIMENTAL

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 GlassesOther: Upgrade Glasses 2

Interventions

Provide free glasses

Group 2: Free GlassesGroup 3: Free + Upgrade Glasses 1Group 4: Free + Upgrade Glasses 2

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)

Group 3: Free + Upgrade Glasses 1

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)

Group 4: Free + Upgrade Glasses 2

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

  • 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.

    PMID: 14985292BACKGROUND
  • 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.

    PMID: 24327616BACKGROUND
  • 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.

    PMID: 20547954BACKGROUND
  • 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.

    PMID: 19104465BACKGROUND
  • 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.

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Nathan Congdon, MD, MPH

    The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD,MPH

Study Record Dates

First Submitted

August 31, 2014

First Posted

September 4, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations