- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03479021
SPOT Vision Screening
April 19, 2018 updated by: Children's Hospital Colorado
Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kyle Phillips
- Phone Number: 720-777-0524
- Email: kyle.phillips@childrenscolorado.org
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045-7106
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Kyle Phillips
- Phone Number: 702-777-0524
- Email: kyle.phillips@childrenscolorado.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 11, 2017
Primary Completion (ANTICIPATED)
May 31, 2019
Study Completion (ANTICIPATED)
May 31, 2019
Study Registration Dates
First Submitted
March 20, 2018
First Submitted That Met QC Criteria
March 20, 2018
First Posted (ACTUAL)
March 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 23, 2018
Last Update Submitted That Met QC Criteria
April 19, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-1911 SPOT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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