Pediatric Red Reflex Study

Purpose

Our Pediatric Red Reflex 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 patient'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, we aim to quantify the utility of this test as a tool for screening by comparing our findings on RRT with those of retinal photography. We 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

Eligibility

Eligible Ages
Under 3 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
RRT Group Pediatric patients undergoing ocular screening tests
  • Diagnostic Test: Direct ophthalmoscope
    Red reflex test

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20010
Contact:
Jana Bregman, MD
202-476-3015
jbregman@childrensnational.org

More Details

NCT ID
NCT04125043
Status
Recruiting
Sponsor
Children's National Research Institute

Study Contact

William Madigan, MD
202-476-3015
WMadigan@childrensnational.org