SPOT Vision Screening
Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2017
CompletedFirst Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedApril 23, 2018
March 1, 2018
2.1 years
March 20, 2018
April 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 months
Interventions
photograph of the eye
Eligibility Criteria
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).
You may qualify if:
- child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening
You may not qualify if:
- glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Coloradolead
- Welch Allyncollaborator
Study Sites (1)
Children's Hospital Colorado
Aurora, Colorado, 80045-7106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2018
First Posted
March 27, 2018
Study Start
May 11, 2017
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
April 23, 2018
Record last verified: 2018-03