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Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
Sponsor: St. Jude Children's Research Hospital
Summary
This study seeks to determine whether a smartphone application called CRADLE (ComputeR Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria. There will be no impact on participants' health outcome. This study will be performed in two parts, each with a distinct cohort of patients. Part 1 will assess the feasibility of various techniques/conditions for using CRADLE within patients known to have leukocoria. Part 2 will estimate the sensitivity and specificity of CRADLE to detect leukocoria (using the techniques selected from information gathered in Part 1) as compared to an ophthalmoscope, within patients referred to the clinic for suspected leukocoria. PRIMARY OBJECTIVES: * To determine the most effective usage of a camera phone application (CRADLE) to maximize detection of leukocoria in patients with retinoblastoma, congenital cataracts, and glaucoma. * To estimate the sensitivity and specificity of a camera phone application (CRADLE) in detecting leukocoria.
Key Details
Gender
All
Age Range
Any - 7 Years
Study Type
INTERVENTIONAL
Enrollment
1
Start Date
2018-03-15
Completion Date
2025-09-30
Last Updated
2026-09-15
Healthy Volunteers
No
Interventions
CRADLE
A smartphone software application designed to detect leukocoria using a sophisticated photoluminic analysis. The investigator or designee will perform tests with CRADLE in separate patient cohorts with known diagnosis of retinoblastoma, congenital glaucoma, or cataracts.
Red reflex testing
Traditional red reflex testing for leukocoria using a direct ophthalmoscope on routine eye examination. Red reflex testing via direct ophthalmoscope will be performed before dilation, using the ophthalmoscope held close to the examiner's eye, focused on the pupil, viewed at 12 to 18 inches from the patient's eyes, with the room lights dimmed, in accordance with the American Academy of Pediatrics guidelines.
Locations (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, United States