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NCT04125043 · ClinicalTrials.gov registry record
Accuracy of the Red Reflex Test in the Pediatric Population
A clinical trial, sponsored by Children's National Research Institute.
- Completed
- Registry status
- 84
- Enrollment target
NCT04125043: Completed study, sponsored by Children's National Research Institute.
NCT04125043 is a clinical trial that has completed, run by Children's National Research Institute. The registered enrollment target is 84 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04125043 has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- 84 participants
- Enrollment target
Study Summary
This study is designed to investigate the sensitivity and specificity of the Red Reflex Test (RRT), with and without dilation, for early detection of ocular abnormalities in children and newborns. The RRT functions by shining a light from an ophthalmoscope into a participant's eye and noting the presence or absence of a red glow. Despite its use in pediatric clinics for years, this test at times fails to detect significant ocular diseases, especially located in the back of the eye, threatening visual development in this population. Therefore, the investigators aim to quantify the utility of this test as a tool for screening by comparing these findings on RRT with those of retinal photography. The investigators hypothesize that the sensitivity and specificity of the RRT will be sufficient for detecting anterior segment pathology but will be insufficient for detecting posterior segment pathology with or without dilation.
Primary Outcome
sensitivity and specificity of the RRT in detecting anterior segment pathology, as well as the sensitivity and specificity of the RRT in detecting posterior segment pathology
Interventions
- DIAGNOSTIC_TEST Direct ophthalmoscope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2023-08-01 |
What the finished NCT04125043 record still lists
NCT04125043 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 84 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Direct ophthalmoscope is the first listed.
NCT04125043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04125043 about?
NCT04125043 is a clinical study titled "Accuracy of the Red Reflex Test in the Pediatric Population". This study is designed to investigate the sensitivity and specificity of the Red Reflex Test (RRT), with and without dilation, for early detection of ocular abnormalities in children and newborns. The RRT functions by shining a light from an ophthalmoscope into a participant's eye and noting the pre...
What is the current status of trial NCT04125043?
This trial is currently completed. The enrollment target is 84 participants. The study started on 2020-03-01. Estimated completion is 2023-08-01.
What interventions are being tested in trial NCT04125043?
The interventions under investigation include: Direct ophthalmoscope (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04125043?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
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