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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Jan 6, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a smartphone application called CRADLE (ComputeR Assisted Detection of LEukocoria) to see if it can help detect leukocoria, a condition where a white reflection appears in the eye and can indicate serious eye problems, such as retinoblastoma (a type of eye cancer) or cataracts. The study has two parts: the first part will explore the best ways to use the app with patients who already have leukocoria, while the second part will compare the app’s ability to detect leukocoria against a traditional eye examination using an ophthalmoscope.

To participate in this trial, patients must meet certain criteria. They may include children diagnosed with congenital cataracts, glaucoma, or retinoblastoma who are visiting an eye doctor for the first time or are newly diagnosed. The trial is open to individuals of all ages, and those who have not received previous treatment for their eye conditions are encouraged to join. Throughout the study, participants will not have any change in their health outcomes as the focus is solely on testing the app. This research could potentially lead to better early detection of eye diseases in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria - Stratum I:
• • Patient has been diagnosed with congenital or infantile cataracts, congenital glaucoma, or retinoblastoma, and is scheduled for a visit with an ophthalmologist at St. Jude Children's Research Hospital or University of Tennessee Hamilton Eye Institute.
• • Patient with retinoblastoma is newly diagnosed, or has received \< 2 cycles of chemoreductive therapy, and has not undergone enucleation.
• • Patient with cataracts or glaucoma has not received any prior therapy.
• Inclusion Criteria - Stratum II:
• • Patient without prior diagnosis has been referred for ophthalmological evaluation, including leukocoria or other conditions.
• Inclusion Criteria - Stratum III:
• • Patient with retinoblastoma undergoing ocular salvage treatment.
• • Exclusion Criteria
• • Prior treatment for cataracts or glaucoma
• • Inability or unwillingness of research participant or legal guardian to consent.