Using a smartphone app to detect eye conditions in children
Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
This study is testing a smartphone app to see if it can help find serious eye problems in children, like cataracts and retinoblastoma, better than regular eye exams.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | N/A to 7 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT03016156 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a smartphone application called CRADLE in detecting leukocoria in infants and children. It consists of two main parts: the first part assesses the feasibility of using CRADLE in patients already diagnosed with leukocoria, while the second part compares its sensitivity and specificity against traditional ophthalmoscope methods in patients referred for suspected leukocoria. The study involves videotaping and photographing participants to gather data on the app's performance in various lighting conditions. The goal is to improve early detection of serious eye conditions such as retinoblastoma, cataracts, and glaucoma.
Who should consider this trial
Good fit: Ideal candidates include infants and children diagnosed with retinoblastoma, congenital cataracts, or congenital glaucoma, as well as those referred for evaluation of leukocoria.
Not a fit: Patients who have previously received treatment for cataracts or glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could lead to earlier and more accurate detection of serious eye conditions in children, potentially improving treatment outcomes.
How similar studies have performed: While the use of smartphone applications for medical detection is a growing field, this specific approach to detecting leukocoria using CRADLE is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Carlos Rodriguez-Galindo, MD — St. Jude Children's Research Hospital
- Study coordinator: Carlos Rodriguez-Galindo, MD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.