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NCT02536963 · ClinicalTrials.gov registry record
Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening
A clinical trial, sponsored by Rebiscan.
- Completed
- Registry status
- 318
- Enrollment target
NCT02536963: Completed study, sponsored by Rebiscan.
NCT02536963 is a clinical trial that has completed, run by Rebiscan. The registered enrollment target is 318 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02536963 has completed, sponsored by Rebiscan.
- COMPLETED
- Registry status
- 318 participants
- Enrollment target
Study Summary
Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not always manifest themselves and pediatricians are unable to reliably detect the conditions. The current health care system badly needs an accurate and effective approach toward detecting amblyopia and strabismus in preschool children. The study will be conducted in busy, ethnically and racially diverse primary care sites operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric Vision Scanner with outcomes the current standard of care.
Primary Outcome
Screening device will provide a binocularity score from 0-100. Scores ≥60 indicate "normal" exams, while scores \<60 are "refers" for amblyopia and strabismus. Device results will be compared to the gold standard eye examination performed by a pediatric ophthalmologist.
Interventions
- DEVICE Pediatric Vision Scanning device
- OTHER Reference examination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-01 |
What the finished NCT02536963 record still lists
NCT02536963 is an observational study that tracks outcomes without assigning an intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Pediatric Vision Scanning device is the first listed.
NCT02536963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02536963 about?
NCT02536963 is a clinical study titled "Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening". Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not al...
What is the current status of trial NCT02536963?
This trial is currently completed. The enrollment target is 318 participants. The study started on 2016-01. Estimated completion is 2019-01.
What interventions are being tested in trial NCT02536963?
The interventions under investigation include: Pediatric Vision Scanning device (DEVICE), Reference examination (OTHER).
Who is sponsoring clinical trial NCT02536963?
This trial is sponsored by Rebiscan, which has 9 total clinical trials registered on ClinicalTrials.gov.
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