Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cataracts Infantile
- Glaucoma Congenital
- Leucocoria
- Retinoblastoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Younger than 7 years
- Gender
- Both males and females
Description
This study will utilize three strata called Stratum I, Stratum II and Stratum III. STRATUM I - Infants and children known to have leukocoria who have been diagnosed with retinoblastoma, cataracts or glaucoma or other eye conditions. Participants enrolled on Stratum I of the study will have the CRADL...
This study will utilize three strata called Stratum I, Stratum II and Stratum III. STRATUM I - Infants and children known to have leukocoria who have been diagnosed with retinoblastoma, cataracts or glaucoma or other eye conditions. Participants enrolled on Stratum I of the study will have the CRADLE application used by the doctor during their appointment. The participant will look straight forward while the doctor stands about 1-3 feet away holding the device that has the CRADLE application. He or she will slowly move the device up, down, middle, right, and left - both in a lit and dimmed room. The participant will be videotaped and photographed during this appointment. The doctor will record the results as determined by CRADLE ("normal" or no leukocoria versus "abnormal" or positive for leukocoria). STRATUM II - Infants and children who are referred to an eye doctor to evaluate for leukocoria. Participants enrolled on Stratum II of the study will be asked to look straight forward while he or she uses the CRADLE application (using the best method determined from Stratum I). The doctor will also examine the participant's eyes with the ophthalmoscope method. The results from both CRADLE and the ophthalmoscope method will be recorded and compared (white eye present versus absent, and normal versus abnormal as described above). STRATUM III - Infants and children receiving treatment for retinoblastoma. For participants enrolled on Stratum III, he or she will have the same procedures as described in Stratum II. After receiving informed consent, participants will undergo evaluation by ophthalmoscope and CRADLE on Day 1. Stratum III participants only will also undergo CRADLE evaluation on Days 2, 3, and 4.
Tracking Information
- NCT #
- NCT03016156
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Carlos Rodriguez-Galindo, MD St. Jude Children's Research Hospital
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