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

NCT03016156 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

  • Retinoblastoma
  • Cataracts Infantile
  • Glaucoma, Congenital
  • Leucocoria

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.

Sponsors & Collaborators

Principal Investigators

  • Carlos Rodriguez-Galindo, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03016156 on ClinicalTrials.gov