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SPOT Vision Screening

Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03479021
Enrollment
100
Registered
2018-03-27
Start date
2017-05-11
Completion date
2019-05-31
Last updated
2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vision Disorders

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.

Interventions

DIAGNOSTIC_TESTWelch-Allyn Spot Vision Screener

photograph of the eye

Sponsors

Welch Allyn
CollaboratorINDUSTRY
Children's Hospital Colorado
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
the SPOT will be effective in screening for amblyogenic risk factors12 monthsthe Spot has a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) necessary to appropriately perform visual triage in developmentally delayed children

Countries

United States

Contacts

Primary ContactKyle Phillips
kyle.phillips@childrenscolorado.org720-777-0524

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026