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Accuracy of the Red Reflex Test in the Pediatric Population

NCT04125043 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 84

Last updated 2023-10-23

No results posted yet for this 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.

Conditions

  • Abnormal Vitreous Humor Morphology
  • Abnormal Choroid Morphology
  • Optic Nerve Diseases
  • Retinal Disease
  • Retinal Hemorrhage

Interventions

DIAGNOSTIC_TEST

Direct ophthalmoscope

Red reflex test

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • William P Madigan, MD · Children's National Research Institute

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2023-07-01
Completion
2023-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04125043 on ClinicalTrials.gov