An observational study in Vision Disorders, sponsored by Children's Hospital Colorado. Status unknown at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by Children's Hospital Colorado · Observational
The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children. These children have a higher percentage of vision disorders than the average population. The SPOT screen itself takes about six seconds to complete. It produces a photograph of the eye and a print out with amount of hyperopia, myopia, astigmatism and pupil size. The subject will have three SPOT screens around the time of their standard of care eye exam. The data obtained from the three SPOT screens will be compared among themselves for accuracy and to the findings of the clinical eye exam.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's planned enrollment of 100 is below the median of 126 across 97 observational studies indexed under Vision Disorders.
Browse Vision Disorders studies →Children's Hospital Colorado is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The children have various disabilities or delays to include: Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), chromosomal abnormalities such as Down Syndrome, Cerebral Palsy (CP), and mental retardation (MR).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening
Exclusion Criteria:
glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener
photograph of the eye
the SPOT will be effective in screening for amblyogenic risk factors
the Spot has a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) necessary to appropriately perform visual triage in developmentally delayed children
Time frame: 12 months
Started May 2017 (actual). Primary completion is estimated for May 2019, 24 months after the start.
Of 51 non-industry observational studies under Vision Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's planned 24 months is close to that.
Counting every sponsor, half of 58 studies reached it within 23 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Children's Hospital Colorado