The Efficacy of a Visual Screening Program to Reduce Later Amblyopia and Untreated Refractive Errors

The Hospital for Sick Children1 site in 1 country2,597 target enrollmentSeptember 2014

ConditionsAmblyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Amblyopia
Sponsor: The Hospital for Sick Children
Enrollment: 2597
Locations: 1
Primary Endpoint: Prevalence of reduced stereo vision
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Amblyopia (lazy eye), is the leading treatable cause of vision loss in childhood. Uncorrected refractive errors (ie farsightedness) can lead to difficulties in school. Unfortunately, many children do not receive vision screening until they have already developed irreversible vision problems. We will conduct a cluster randomized clinical trial in which schools, not individual children, are randomly allocated to receive a kindergarten visual screening program or to receive no intervention by the research team (i.e., "care as usual"). We will compare the prevalence of visual problems (and proportion of children with reading problems) when the children are in Grade 2, after allowing for at least one year of treatment.

Detailed Description

The proposed study is a single-masked cluster randomized clinical trial, with randomization and analyses occurring at the level of "schools" (i.e., we are not randomly assigning individuals to groups). To assess the efficacy of a visual screening program, we will compare visual outcomes in 25 schools randomly chosen to receive the program and 25 schools allocated to "care as usual" one year after screening. The screening tools are HOTV crowded acuity, Preschool Randot Stereoacuity Test, and Plusoptix Autorefractor. The outcome measures will assess later differences between schools receiving the visual screening program and control schools for prevalence of (1) visual and (2) reading problems. A lower prevalence of either or both problems in schools where the visual screening program was offered would provide evidence for the efficacy of vision screening. Primary outcome measure is the prevalence of amblyopia, reduced stereo vision, and untreated clinically significant refractive errors in "screened" versus "care as usual" schools. Secondary outcome measure is the proportion of children performing 1 standard deviation below average on reading scores in "screened" versus "care as usual" schools.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

December 15, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group