Smartphone App Detection for Retinoblastoma
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: St. Jude Children's Research Hospital
Disqualifiers: Prior treatment cataracts, glaucoma, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing a smartphone app called CRADLE to help detect leukocoria in children. The app takes pictures of the eyes and looks for signs of this condition. It aims to improve early detection in kids who have or might have serious eye diseases.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a smartphone app for detection, so it's unlikely to require changes to your medication.
What data supports the effectiveness of the treatment CRADLE, White Eye Detector, ComputeR Assisted Detector of LEukocoria, Red reflex testing, Red Reflex Test, Ophthalmoscope Examination for detecting retinoblastoma?
Research shows that the CRADLE app, also known as the White Eye Detector, can identify leukocoria (white pupil) in photos, detecting eye disorders like retinoblastoma up to 1.3 years before diagnosis. This app, along with red reflex testing, helps in early detection, which is crucial for better outcomes.12345
Is the smartphone app for detecting retinoblastoma safe to use?
How does the smartphone app treatment for retinoblastoma differ from other treatments?
The smartphone app treatment for retinoblastoma is unique because it allows for early detection of the condition through a simple, non-invasive method using a smartphone camera to identify leukocoria (white pupil) in photographs. This approach is more accessible and affordable compared to traditional methods that require specialized equipment and healthcare professionals.12378
Eligibility Criteria
This trial is for patients with retinoblastoma, congenital cataracts, or glaucoma who are visiting St. Jude Children's Research Hospital or University of Tennessee Hamilton Eye Institute. It includes new or minimally treated retinoblastoma cases and those referred for eye conditions like leukocoria.Inclusion Criteria
I have a diagnosis of cataracts, glaucoma, or retinoblastoma and am seeing an eye specialist at St. Jude or UT.
Stratum II: Patient without prior diagnosis has been referred for ophthalmological evaluation, including leukocoria or other conditions.
I am receiving treatment to save my eye from retinoblastoma.
Exclusion Criteria
I have had treatment for cataracts or glaucoma.
I am unable or unwilling to give consent for the study.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Initial Evaluation
Participants undergo initial evaluation using the CRADLE application and ophthalmoscope to assess leukocoria
1 day
1 visit (in-person)
Follow-up Evaluation
Participants in Stratum III undergo additional CRADLE evaluations on Days 2, 3, and 4 to compare with ophthalmoscope results
4 days
3 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after initial evaluations
3-4 weeks
Treatment Details
Interventions
- CRADLE (Behavioural Intervention)
- Red reflex testing (Procedure)
Trial OverviewThe study tests the CRADLE smartphone app's ability to detect leukocoria compared to traditional red reflex testing using an ophthalmoscope. The trial has two parts: finding the best way to use CRADLE and measuring its accuracy (sensitivity and specificity).
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Stratum III: Retinoblastoma GroupExperimental Treatment2 Interventions
A separate group of participants with known retinoblastoma and who are undergoing ocular salvage treatments will be screened with red reflex testing using direct ophthalmoscopy on Day 1. They will also undergo testing with the CRADLE software application defined as the most effect in Stratum I on Day 1 then for three additional consecutive visits which typically occur every 3 to 4 weeks.
Group II: Stratum II: Leukocoria Evaluation GroupExperimental Treatment2 Interventions
A separate group of participants who are referred for evaluation of leukocoria or any other eye condition will undergo red reflex testing testing with CRADLE on Day 1.
Group III: Stratum I: Initial Evaluation GroupExperimental Treatment1 Intervention
Initially, a small group of patients diagnosed with congenital or infantile cataracts, congenital glaucoma or retinoblastoma and who meet the eligibility criteria will undergo testing with CRADLE on Day 1.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Jude Children's Research HospitalMemphis, TN
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Who Is Running the Clinical Trial?
St. Jude Children's Research HospitalLead Sponsor
References
Smartphone-based application improves the detection of retinoblastoma. [2021]To improve and validate the smartphone-based leukocoria detection application so that non-ophthalmologists could make use of the smartphone for early detection of Retinoblastoma (RB) in young children without anesthesia and pharmacological dilatation of the pupil.
EyeScreen: Development and Potential of a Novel Machine Learning Application to Detect Leukocoria. [2022]Early diagnosis and treatment of retinoblastoma are of paramount importance for a positive clinical outcome. The most common sign of retinoblastoma is leukocoria, or white pupil. Effective, easy-to-perform, community-based screening is needed to improve outcomes in lower-income regions. The EyeScreen (developed by Joshua Meyer from the University of Michigan) Android (Google LLC) smartphone application is an important step toward addressing this need. The purpose of this study was to examine the potential of the novel use of low-cost technologies-a cell phone application and machine learning-to identify leukocoria.
Autonomous early detection of eye disease in childhood photographs. [2020]The "red reflex test" is used to screen children for leukocoria ("white eye") in a standard pediatric examination, but is ineffective at detecting many eye disorders. Leukocoria also presents in casual photographs. The clinical utility of screening photographs for leukocoria is unreported. Here, a free smartphone application (CRADLE: ComputeR-Assisted Detector of LEukocoria) was engineered to detect photographic leukocoria and is available for download under the name "White Eye Detector." This study determined the sensitivity, specificity, and accuracy of CRADLE by retrospectively analyzing 52,982 longitudinal photographs of children, collected by parents before enrollment in this study. The cohort included 20 children with retinoblastoma, Coats' disease, cataract, amblyopia, or hyperopia and 20 control children. For 80% of children with eye disorders, the application detected leukocoria in photographs taken before diagnosis by 1.3 years (95% confidence interval, 0.4 to 2.3 years). The CRADLE application allows parents to augment clinical leukocoria screening with photography.
Towards early detection of retinoblastoma. [2019]Survival rates for retinoblastoma (RB) in a region of South Africa (SA) of only 50% reflect the high frequency of late presentation, the simple reason for which is lack of effective screening. Early detection of suspected RB would significantly reduce this unacceptably high mortality rate. The SA health system has the expertise to manage a child with RB well. The issue at stake is timely referral of the affected child to one of the specialist treatment centres. Until universal screening with digital imaging becomes a reality, the red reflex test should be mandatory at discharge from all neonatal services and at all subsequent routine health supervision visits. Most RBs would then be detected early.
The detection of simulated retinoblastoma by using red-reflex testing. [2010]To determine the ability to detect simulated retinoblastoma by using the red-reflex test.
The red reflex examination in neonates: an efficient tool for early diagnosis of congenital ocular diseases. [2019]The American Academy of Pediatrics recently published recommendations for the red reflex assessment in the newborn period to detect and treat ocular disorders as early as possible, and to prevent lifelong visual impairment and even save lives. The test is technically simple to perform, non-invasive, requires minimal equipment and can detect a variety of ocular pathologies including cataracts and retinal abnormalities. No specific national guidelines exist on this issue.
Detection and Diagnosis of Retinoblastoma: Can Mobile Devices Be the Next Step Toward Early Intervention? [2022]Retinoblastoma (RB) is a common intraocular cancer in pediatric patients worldwide, and screening is routinely performed throughout the first few years of life. The diagnosis is often made clinically; however, the diagnosis can be delayed due to undetectable leukocoria because of small tumor size at the time of examination, missed appointments, non-compliance with eye examinations, or failure to perform the exam. As mobile devices continue to gain in both popularity and functionality, their use via applications and smartphone attachments for ocular examination introduces a new avenue for screening, detection, and staging of RB both inside and outside the clinical setting. Currently, research regarding mobile device use is still in its infancy, and further research is required to determine whether mobile devices could play a significant role in assisting with the diagnosis of RB. The purpose of this systematic review was to determine whether the existing literature supports the use of mobile devices by healthcare providers, specifically ophthalmologists and non-ophthalmologists, as well as by parents for the early detection of RB. A comprehensive literature search was conducted via PubMed, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science with a total of 10 studies included in the final analysis.
Use of smartphones for detecting diabetic retinopathy: a protocol for a scoping review of diagnostic test accuracy studies. [2020]Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of impaired vision in adults worldwide. Early detection and treatment for DR could improve patient outcomes. Traditional methods of detecting DR include the gold standard Early Treatment Diabetic Retinopathy Study seven standard fields fundus photography, ophthalmoscopy and slit-lamp biomicroscopy. These modalities can be expensive, difficult to access and require involvement of specialised healthcare professionals. With the development of mobile phone technology, there is a growing interest in their use for DR identification as this approach is potentially more affordable, accessible and easier to use. Smartphones can be employed in a variety of ways for ophthalmoscopy including the use of smartphone camera, various attachments and artificial intelligence for obtaining and grading of retinal images. The aim of this scoping review is to determine the diagnostic test accuracy of various smartphone ophthalmoscopy approaches for detecting DR in diabetic patients.