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NCT04321538 · ClinicalTrials.gov registry record
Gocheck Kids vs. Welch Allyn Spot Vision Screener
A clinical trial of Amblyopia, sponsored by Yale University.
- Completed
- Registry status
- 227
- Enrollment target
- 1
- Study location
NCT04321538: Completed study of Amblyopia, sponsored by Yale University.
NCT04321538 is a study of Amblyopia that has completed, run by Yale University. The registered enrollment target is 227 participants, above the 156-participant average among 24 other Amblyopia trials with a reported enrollment target (46% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04321538, a study of Amblyopia, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 227 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators are conducting a prospective evaluation of the ability of two vision photoscreening devices (GoCheck Kids and the Welch Allyn Spot Vision Screener) to detect risk factors for amblyopia. Photoscreeners function similar to having a picture taken with a camera. Amblyopia is decreased vision in one or both eyes due to decreased vision development in the brain resulting from decreased visual stimulation. Children ages 1 year to less than 7 years of age referred to a pediatric ophthalmologist at Yale New Haven Health and Yale Medicine locations for a failed vision screen will be offered participation. The ability of each screening device to detect amblyopia risk factors will be compared with the results of a complete eye exam performed by the practitioner.
Primary Outcome
The sensitivity is the percentage of patients with amblyopia whose vision screen indicates they have an amblyopia risk factor. The sensitivity for the detection of amblyopia risk factors is determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens by the photoscreener (as determined by the gold standard physical exam including cycloplegic retinoscopy to look for refractive error and ocu
Conditions Studied
Interventions
- DEVICE Gocheck Kids
- DEVICE Welch Allyn Spot Vision Screener
- DIAGNOSTIC_TEST Physical Exam
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2022-12-19 |
What the finished NCT04321538 record still lists
NCT04321538 is an observational study that tracks outcomes without assigning an intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, above the 156-participant average among 24 other Amblyopia trials with a reported enrollment target (46% higher).
The record links to 1 condition, with Amblyopia appearing as the primary indexed condition, and to 3 interventions - of which Gocheck Kids is the first listed.
NCT04321538 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04321538 about?
NCT04321538 is a clinical study titled "Gocheck Kids vs. Welch Allyn Spot Vision Screener". The investigators are conducting a prospective evaluation of the ability of two vision photoscreening devices (GoCheck Kids and the Welch Allyn Spot Vision Screener) to detect risk factors for amblyopia. Photoscreeners function similar to having a picture taken with a camera. Amblyopia is decreased ...
What is the current status of trial NCT04321538?
This trial is currently completed. The enrollment target is 227 participants. The study started on 2021-02-01. Estimated completion is 2022-12-19.
What conditions does trial NCT04321538 study?
This clinical trial studies the following conditions: Amblyopia.
What interventions are being tested in trial NCT04321538?
The interventions under investigation include: Gocheck Kids (DEVICE), Welch Allyn Spot Vision Screener (DEVICE), Physical Exam (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04321538?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04321538 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amblyopia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04321538's enrollment target sits among peer trials
227 7th of 24 higher than 18 of 24 other Amblyopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amblyopia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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