Accuracy of the Red Reflex Test in the Pediatric Population

NCT04125043 | Completed

• 1 other identifier: Pro00011173
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Red reflex; Posterior ocular abnormalities

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of RRT

  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

  1 year

Secondary Outcomes (1)

• Sensitivity and Specificity of RRT with Dilation

  1 year

Study Arms (1)

RRT Group

Pediatric patients undergoing ocular screening tests

Diagnostic Test: Direct ophthalmoscope

Interventions

Direct ophthalmoscope DIAGNOSTIC_TEST

Red reflex test

RRT Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric patients under 18 years old recruited in clinical practice with known anterior or posterior segment pathology as well as patients without anterior or posterior segment pathology.

You may qualify if:

• Pediatric patients recruited in clinical practice with known anterior or posterior segment pathology as well as patients without anterior or posterior segment pathology

You may not qualify if:

• Patients who have a history of disease, treatments and/or surgical procedures affecting the ability for normal pupillary reaction

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Optic Nerve Diseases; Retinal Diseases; Retinal Hemorrhage

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William P Madigan, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Ophtamology

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: March 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)