Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Welch Allyn | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Welch-Allyn Spot Vision Screener | Diagnostic Test | photograph of the eye |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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
Not provided
Not provided
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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyle Phillips | Contact | 720-777-0524 | kyle.phillips@childrenscolorado.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045-7106 | United States |
Not provided
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |