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Efficacy of Visual Screening in Ontario

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Crowded HOTV Acuity Test
Preschool Randot Stereoacuity Test
Plusoptix Autorefractor
Comprehensive Eye Exam
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amblyopia

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Screened Schools

Care As Usual Schools

Arm Description

25 schools. Screening involved: crowded HOTV acuity test, Preschool Randot Stereoacuity Test, and Plusoptix autorefractor. Referral criteria followed AAPOS guidelines for screening for amblyopia and amblyopia risk factors. Children who fail any one of the three tests (including uncooperative/unable children) will be given a referral letter, which includes an assigned appointment time for a comprehensive eye exam at school with a licensed optometrist. Any needed glasses will be dispensed at no cost to the parents. 6 months after the eye exam, we will follow up with a phone call to parents to offer any additional support (such as replacing broken/lost glasses)

25 schools were randomly allocated to the "care as usual" schools. No intervention was provided by the research team, however, children may have received optometry/ophthalmology care via regular referral channels (e.g., family physicians, teachers)

Outcomes

Primary Outcome Measures

Prevalence of amblyopia
Prevalence of suspected amblyopia, defined as 2-or-greater line difference in acuity between eyes
Prevalence of refractive errors
Untreated clinically significant refractive errors defined by AAPOS (2013) guidelines
Prevalence of reduced stereo vision
Stereoacuity is often reduced in patients with some types of amblyopia, and will defined as worse than 30 arcsec

Secondary Outcome Measures

Proportion of below-average readers Year 1
Proportion of Grade 1 children reading 1 SD below average
Proportion of below-average readers Year 2
Proportion of Grade 2 children reading 1 SD below average

Full Information

First Posted
January 8, 2015
Last Updated
March 17, 2020
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02458846
Brief Title
Efficacy of Visual Screening in Ontario
Official Title
The Efficacy of a Visual Screening Program to Reduce Later Amblyopia and Untreated Refractive Errors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screened Schools
Arm Type
Experimental
Arm Description
25 schools. Screening involved: crowded HOTV acuity test, Preschool Randot Stereoacuity Test, and Plusoptix autorefractor. Referral criteria followed AAPOS guidelines for screening for amblyopia and amblyopia risk factors. Children who fail any one of the three tests (including uncooperative/unable children) will be given a referral letter, which includes an assigned appointment time for a comprehensive eye exam at school with a licensed optometrist. Any needed glasses will be dispensed at no cost to the parents. 6 months after the eye exam, we will follow up with a phone call to parents to offer any additional support (such as replacing broken/lost glasses)
Arm Title
Care As Usual Schools
Arm Type
No Intervention
Arm Description
25 schools were randomly allocated to the "care as usual" schools. No intervention was provided by the research team, however, children may have received optometry/ophthalmology care via regular referral channels (e.g., family physicians, teachers)
Intervention Type
Other
Intervention Name(s)
Crowded HOTV Acuity Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Preschool Randot Stereoacuity Test
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Plusoptix Autorefractor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Eye Exam
Intervention Description
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 Outcome Measure Information:
Title
Prevalence of amblyopia
Description
Prevalence of suspected amblyopia, defined as 2-or-greater line difference in acuity between eyes
Time Frame
16 months
Title
Prevalence of refractive errors
Description
Untreated clinically significant refractive errors defined by AAPOS (2013) guidelines
Time Frame
16 months
Title
Prevalence of reduced stereo vision
Description
Stereoacuity is often reduced in patients with some types of amblyopia, and will defined as worse than 30 arcsec
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Proportion of below-average readers Year 1
Description
Proportion of Grade 1 children reading 1 SD below average
Time Frame
10 months
Title
Proportion of below-average readers Year 2
Description
Proportion of Grade 2 children reading 1 SD below average
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Wong
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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Efficacy of Visual Screening in Ontario

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