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NCT03479021 Clinical Trial

SPOT Vision Screening

Vision Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03479021
Other study ID # 16-1911 SPOT
Secondary ID
Status Recruiting
Phase
First received March 20, 2018
Last updated April 19, 2018
Start date May 11, 2017
Est. completion date May 31, 2019

Study information
Verified date March 2018
Source Children's Hospital Colorado
Contact Kyle Phillips
Phone 720-777-0524
Email kyle.phillips@childrenscolorado.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Welch-Allyn Spot Vision Screener
photograph of the eye

Locations
Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (2)
Lead Sponsor Collaborator
Children's Hospital Colorado Welch Allyn

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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