Accuracy of the Red Reflex Test in the Pediatric Population

Sensitivity and Specificity of the Red Reflex Test for Detecting Anterior and Posterior Segment Ophthalmic Pathology 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 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.

Study Overview

• Status: Completed
• Conditions: Optic Nerve Diseases; Retinal Disease; Retinal Hemorrhage; Abnormal Vitreous Humor Morphology; Abnormal Choroid Morphology
• Intervention / Treatment: Diagnostic test: Direct ophthalmoscope

Detailed Description

Pediatric patients will be recruited through clinical practice at the designated study sites. Participants with known anterior segment or posterior segment pathology will be eligible for inclusion. Patients who have a history of disease, treatments and/or surgical procedures affecting the ability for normal pupillary reaction are excluded. An equal number of age matched participants with a normal anterior and posterior segment exam will be recruited from routine outpatient ophthalmology clinic appointments. Informed consent will be obtained and will include an option to be considered for medical photography. Participants may opt out of photography and still be included in the study. For Spanish speaking participants, an interpreter will be used for study recruitment and informed consent. A Spanish informed consent (developed by a Spanish medical translator from our English written consent) will be provided. Current estimated number of subjects required for the study is 200 total including 100 controls. Patient charts will be accessed from date of birth to patient's current age using either Cerner or Epic depending on the study site location. Examiners will include ophthalmology residents with one completed year of ophthalmology training. They will be blinded to participants' ophthalmologic history.

Pupil size will be recorded under ambient lighting conditions and the red reflex test (RRT) performed at 18 cm using a direct ophthalmoscope (Welch Allyn 11710 or similar). Each eye will then be inspected individually at 1 cm. Examiner description of the pupillary reflex in terms of color, brightness, and the presence or absence of potential anterior/posterior segment abnormality will be recorded using a standardized survey tool. The exam room lights will then be turned off and the pupils examined again with the direct ophthalmoscope according to the standard RRT procedure and results recorded.

Next, pharmacological dilation will be achieved according to standard practices. For all patients, one drop of proparacaine hydrochloride ophthalmic solution will be instilled in each eye to achieve anesthesia. For patients under 1 year old, one drop of Cyclomydril will then be instilled in each eye and followed second drop in each eye 5 minutes later. For children over 1 year of age, pharmacologic dilation will be achieved with 1 drop of Cyclopentolate 1% and 1 drop of Phenylephrine 2.5% in each eye. The RRT will be repeated by the same examiner, including the lights on and lights off portions of the exam, and the results recorded.

Subjects will be de-identified and results will be stored on a password protected Children's National Hospital computer and pertinent statistical analyses will be perform to asses our hypothesis. All statistical tests will be performed at the 5% level of significance unless otherwise stated.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RRT Group; Pediatric patients undergoing ocular screening tests	Diagnostic test: Direct ophthalmoscope; Red reflex test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of RRT with Dilation	the sensitivity and specificity of the RRT in detecting anterior segment or posterior segmented pathology following pharmacologic dilation	1 year

Collaborators and Investigators

• Sponsor: Children's National Research Institute
• Investigators: Principal Investigator: William P Madigan, MD, Children's National Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Red reflex; Posterior ocular abnormalities
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Cranial Nerve Diseases; Eye Hemorrhage; Retinal Diseases; Hemorrhage; Nervous System Diseases; Optic Nerve Diseases; Retinal Hemorrhage
• Other Study ID Numbers: Pro00011173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No