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SPOT Vision Screening

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ClinicalTrials.gov Identifier: NCT03479021
Recruitment Status : Unknown
Verified March 2018 by Children's Hospital Colorado.
Recruitment status was:  Recruiting
First Posted : March 27, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Welch Allyn
Information provided by (Responsible Party):
Children's Hospital Colorado

Study Description
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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.

Condition or disease Intervention/treatment
Vision Disorders Diagnostic Test: Welch-Allyn Spot Vision Screener

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

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Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Welch-Allyn Spot Vision Screener
    photograph of the eye

Outcome Measures
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Primary Outcome Measures :
  1. the SPOT will be effective in screening for amblyogenic risk factors [ Time Frame: 12 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479021


Contacts
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Contact: Kyle Phillips 720-777-0524 kyle.phillips@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045-7106
Contact: Kyle Phillips    702-777-0524    kyle.phillips@childrenscolorado.org   
Sponsors and Collaborators
Children's Hospital Colorado
Welch Allyn
More Information
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Responsible Party: Children's Hospital Colorado
ClinicalTrials.gov Identifier: NCT03479021    
Other Study ID Numbers: 16-1911 SPOT
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases