An interventional study of Crowded HOTV Acuity Test and Preschool Randot Stereoacuity Test in Amblyopia, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 3 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Diagnostic
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.
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.
183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.
This study's enrollment of 2,597 is above the median of 60 across 133 interventional studies indexed under Amblyopia.
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Exclusion Criteria:
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)
Other: Crowded HOTV Acuity Test · Other: Preschool Randot Stereoacuity Test · Device: Plusoptix Autorefractor · Other: Comprehensive Eye Exam
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)
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.
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.
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.
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.
Prevalence of amblyopia
Prevalence of suspected amblyopia, defined as 2-or-greater line difference in acuity between eyes
Time frame: 16 months
Prevalence of refractive errors
Untreated clinically significant refractive errors defined by AAPOS (2013) guidelines
Time frame: 16 months
Prevalence of reduced stereo vision
Stereoacuity is often reduced in patients with some types of amblyopia, and will defined as worse than 30 arcsec
Time frame: 16 months
Proportion of below-average readers Year 1
Proportion of Grade 1 children reading 1 SD below average
Time frame: 10 months
Proportion of below-average readers Year 2
Proportion of Grade 2 children reading 1 SD below average
Time frame: 22 months
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