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Completed

NCT Number: NCT02458846

Efficacy of Visual Screening in Ontario

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.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Screening: children enrolled in senior kindergarten (age 5-6 years)
  • Follow-up: children enrolled in Grade 2 (age 7-8 years)

Exclusion criteria

  • None

Treatment and study plan

Crowded HOTV Acuity Test

Other

This is one of the most sensitive tests of acuity for vision screening of young children. The child is asked to recognize a letter (H,O,T,V) that is surrounded by bars to induce the crowding effects typical of amblyopia. Children were tested monocularly and was required to achieve at least 20/32 in each eye to pass. Children already wearing glasses were tested with their glasses on.

Preschool Randot Stereoacuity Test

Other

This is a reliable screening test for stereo depth perception for young children. Children wear polarized stereoglasses and are asked to identify or match shapes that are "hiding in the snow", which cannot be perceived if the child has abnormal binocular vision. Children were required to achieve at least 60 arcseconds of disparity to pass. Children already wearing glasses were tested with their glasses worn under the stereo glasses.

Plusoptix Autorefractor

Device

Autorefractors are electronic devices that measure refractive errors by focusing a light onto the child's eyes and recording how their reflections from the retina return to the camera. The Plusoptix has been shown to have high sensitivity and specificity in previous research. AAPOS (2013) guidelines were used to determine the referral criteria.

Comprehensive Eye Exam

Other

Children who did not pass all three screening tests were referred for full cycloplegic optometry exams, with a parent/guardian present. Optometrists assessed visual history, monocular visual acuity (near & far), strabismus, binocular function, abnormalities of the anterior segment, and cycloplegic refraction. If the optometrist prescribed glasses, frames were chosen at the time of the exam and the glasses were dispensed either at school (with an optician) or at the optometrist's office.

Primary outcomes

  1. Prevalence of amblyopia

    Time frame: 16 months

    Prevalence of suspected amblyopia, defined as 2-or-greater line difference in acuity between eyes

  2. Prevalence of refractive errors

    Time frame: 16 months

    Untreated clinically significant refractive errors defined by AAPOS (2013) guidelines

  3. Prevalence of reduced stereo vision

    Time frame: 16 months

    Stereoacuity is often reduced in patients with some types of amblyopia, and will defined as worse than 30 arcsec

Secondary outcomes

  1. Proportion of below-average readers Year 1

    Time frame: 10 months

    Proportion of Grade 1 children reading 1 SD below average

  2. Proportion of below-average readers Year 2

    Time frame: 22 months

    Proportion of Grade 2 children reading 1 SD below average

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2015
Registry last updated
Mar 19, 2020

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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