Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma

NARecruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

March 15, 2018

Primary Completion Date

July 30, 2025

Study Completion Date

July 30, 2026

Conditions
RetinoblastomaCataracts InfantileGlaucoma, CongenitalLeucocoria
Interventions
OTHER

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."

OTHER

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.

Trial Locations (1)

38105-2794

RECRUITING

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER